The Standard 2012 Winter

USP Headquarters Maryland, USA

Europe/Middle East/Africa Basel, Switzerland

USP–India Private Ltd. Hyderabad, India

USP–China Shanghai, China

USP–Brazil São Paulo, Brazil

QUA L IT Y S TA NDA RDS f or Me dic ine s , Die t ar y Supplement s , and Fo o d Ing re dient s WO RL DWIDE

CEO Column2 Message from the CEO

Solving USP’s “Riddle of the Sphinx”

USP Science4 In Pursuit of Modern,

Comprehensive Compendia

5 Proposed General Chapter Addresses Subvisible Particulate Matter in Therapeutic Protein Injections

6 USP Identification Tests to Be Modernized

More...

International9 Global Public Health View, Flexible

Standards-Setting Approach Drive New Compendium

10 USP Collaborates with FDA, IPC on India Courses

11 Global Quality Standards for Biologics and Supply Chain Management the Focus of Mumbai Meeting

12 First Global Summit of Pharmacopeias Hosted in Beijing

More...

PQM Program15 PQM Assists Ethiopia in Achieving

International Laboratory Accreditation

More...

Inside USP16 Global Philanthropic Health Initiatives

Strengthened with New USP Vice President of Development

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In this Issue

VOL. 9 | ISSUE 2 | Winter 2012

Building on nearly two centuries of work dedicated to helping ensure the quality of medicines, and a mission to improve the health of people worldwide, the USP Board of Trustees pledged $1.5 million in matching funds to support the establishment of a new USP-Africa Center for Pharmaceutical Advancement & Training (CePAT) in February 2012. The center will be located in Accra, Ghana, and is intended to serve the entire sub-Saharan Africa region.

The vision for the center is to function as an integrated platform for training,

education, consulting and laboratory capabilities, offering a systematic approach to the quality control of medicines in sub-Saharan Africa. Through these services, the center will aim to address shortfalls in human and laboratory resources and supply chain control to build the capacity of African professionals in quality control and quality assurance of medicines.

Sub-Saharan Africa has the lowest life expectancy, the highest infant and under-five mortality rates, and the highest maternal mortality rate in the world. It also has the highest burden of HIV prevalence among adults, malaria mortality rate and tuberculosis prevalence. Moreover, Africa is facing an increasing burden from non-communicable diseases. “The convergence of these complex challenges will require significant new investment and growth of health services to provide the African people with the appropriate prevention and treatment interventions, especially access to good-quality medicines,” explained Mr. Brian Hendrix, USP executive vice president and chief operating officer, who is spearheading an expansion of USP’s philanthropic outreach in support of global public health.

Sub-Saharan African countries face fundamental problems that have created an environment where substandard and counterfeit medicines have flourished. These are tied to the limited resources of regulatory regimes in African nations, with a shortage of qualified personnel at national laboratories, heavy dependence on imported medicines with a lack of adequate oversight, and poor compliance with Good Manufacturing Practices in the limited cases where local manufacturing exists. “CePAT can play an important role in helping to address these challenges,” according to Mr. Hendrix.

Planned USP-Africa Center to Improve Quality of Medicines in Sub-Saharan RegionSubstandard and Counterfeit Medicines Take Health, Economic Toll

Continued on page 14. See USP-Africa Center

USP CEO Roger L. Williams is welcomed to Ghana. USP expects a new center located in the country to open in 2013.

ISO 9001:2008 Certified

The Standard Winter 20122

In this Issue ContinuedUSP Science6 USP Proposes New Standards for

Orally and Nasally Inhaled Medicines

7 Adulteration of Foods and Dietary Supplements Workshop Examines Current Vulnerabilities, the Role of Standards

8 Critical Quality Considerations for Probiotics and Other Microbial Food Cultures Offered in New Draft FCC Standards

International13 International Exchange Furthered

with USP Japan Trip

13 Chile and USP Strengthen Ties, Commitment to Quality Medicines

PQM Program15 PQM Establishes Medicines Quality

Monitoring in Yunnan, China

Inside USP16 USP Launches New Website

Message from the CEO

This edition of The Standard is the eighth in the 2010–2015 USP cycle and thus marks two years of intense volunteer and staff activity as we head toward the spring of 2015—the time of the 25th Convention and just five years shy of USP’s 200th anniversary. I like to share this column with key USP staff, and two recent issues had excellent columns on USP’s secretariats from Ms. Angela Long (fall 2011) and on USP’s philanthropic activities from Mr. Brian Hendrix (summer 2011). This column expands on that tradition in interviews on pages four and nine with two members of USP’s executive team: Dr. Praveen Tyle, executive vice president and our new chief science officer, and Dr. Srini Srinivasan, executive vice president, international science and standards.

Dr. Tyle is responsible for USP’s U.S.-based compendia for food and drugs, including the United States Pharmacopeia–National Formulary (USP–NF), while Dr. Srinivasan is responsible for the new USP Medicines Compendium (MC) as well as for our international sites. My opportunity now is to set the stage for their remarks. While my further comments here focus on drugs, I will devote upcoming columns to standards for foods and their ingredients. These topics will provide rich themes as USP heads to its Science & Standards Symposium in Boston, September 17–21, 2012, which will be entirely devoted to foods, including dietary supplements and excipients.

Turning then to drugs, I start with the somber observation that I am at times dismayed by the arguments people give on why there should not be a good public monograph with allied reference materials for all drugs moving in commerce. These range from the presence of manufacturers’ proprietary in-house quality standards (particularly when there is only one manufac-turer in a market), to resource constraints, to perceived threats to intellectual property, and other objections as well. During my 12-year tenure at USP, I have thought of such arguments against public monographs as my “riddle of the sphinx”—one that ultimately will be solved, but that has, to date, thwarted most attempts to do so. USP has worked to refute these positions, but their currency can be maintained with unusual tenacity.

Solving USP’s “Riddle of the Sphinx”

I am at times dismayed by the arguments people give on why there should not be a good public monograph with allied reference materials for all drugs moving in commerce. Roger L. Williams, Chief Executive Officer, USP

Roger L. Williams, M.D.

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Convention News

These views are not without consequences for public health. For USP–NF, approximately 50 percent of the book is either missing or needs updating, and similar observations could be made about other pharmacopeias of the world. Probably most of the medicines moving in global commerce lack good public mono-graphs and reference materials. MC was designed to help correct these deficiencies through such measures as performance-based monographs, which provide tests for critical quality attributes and acceptance criteria but do not give step-by-step instructions, thereby allowing manufacturers and regulators greatly increased flexibility. So it is a good time to ask, roughly eight months since MC’s public debut in July 2011: how is it doing?

Well, it is doing very well and we are learning a lot. In a relatively short time, 15 monographs have been finalized and another 90 are in various stages in the pipeline, through a highly efficient public process. We are learning the pleasure of working with new and enthusiastic members of the 21st Expert Committee of the Council of Experts. Many of these experts come from manufacturers outside the United States who find strong value in pharmacopeial standards as a means of instilling consumer and practitioner confidence in medicines. We are learning how to create on our own a public monograph with reference materials rather than relying solely on manufacturer donations. And last but certainly not least, we are finding that work on MC lends itself to getting new monographs and updating existing ones in USP–NF.

These new opportunities have the capacity to protect all stakeholders, including manufacturers as well as practitioners, patients and regulatory agencies such as the U.S. Food and Drug Administration. This could happen by helping combat counterfeit or substandard medicines and by providing a com-mon standard that follow-on or generic versions of a pioneer drug can follow. USP does not engage in market access decisions and works to protect confidential commercial and trade secret information. MC respects these commitments yet allows expan-sion of good drug monographs with reference materials both within and outside the United States. It thus synergizes with and supplements the already strong donor activity now ongoing in the United States.

Does this sound too good to be true? Perhaps, but what a wonderful world it would be if USP could finally solve its “riddle of the sphinx” in ways that would advance not only its pharmacopeias but also those of other countries and regions, not to mention The International Pharmacopoeia of the World Health Organization. Global public health would surely be strengthened through such collaboration. I encourage readers to proceed to interviews with Drs. Tyle and Srinivasan to get a broader picture of what USP is doing to advance standards for foods and drugs in this very complicated world in which we live. u

USP Welcomes New Convention Members

Organizations Representing Consumers and Public Interest•Alzheimer’sAssociation•AmericanAutoimmuneRelatedDiseasesAssociation•AmericanCancerSociety•AmericanChildhoodCancerOrganization•AmericanHeartAssociation•ArthritisFoundation• BillandMelindaGatesFoundation•ConsumerFederationofAmerica•ConsumersInternational• FamiliesUSA•GlobalHealthCouncil• InternationalAllianceofPatients’Organizations•NationalCouncilonPatientInformationandEducation•NationalOsteoporosisFoundation•WilliamJ.ClintonFoundation

Non-Governmental Standards-Setting Bodies•AccreditationCouncilforPharmacyEducation•AssociationfortheAdvancementofMedicalInstrumentation•ASTMInternational•ClinicalandLaboratoryStandardsInstitute• PharmacyCompoundingAccreditationBoard•URAC

Academic Institutions•ChicagoStateUniversityCollegeofPharmacy•NOVASoutheasternUniversityCollegeofOsteopathic

Medicine

Health Practitioner Professional and Scientific Associations•AmericanSocietyforNutrition

Manufacturer and Trade Associations•ChinaNationalFoodIndustryAssociation

Governmental Bodies•NationalInstituteofNutritionandFoodSafety,People’sRepublicofChina

Delegates Invited to CoC Listening Tour Dinners

The Council of the Convention (CoC) has embarked on a listening tour to understand issues of importance to Conven-tion member organizations. Through in-person meetings, the CoC will learn what delegates and executive officers see on the healthcare horizon and how USP can play a meaningful role. To facilitate broad participation, events will be held in various locations. The first dinner was held March 10 in conjunction with the American Pharmacists Association’s 2012 Annual MeetinginNewOrleans.ThesecondeventisscheduledforJune in Chicago, in conjunction with the American Medical Association’s 2012 Annual Meeting. Feedback will be posted at uspgo.to/listeningtour and will inform the CoC as it begins todevelopResolutionsforconsiderationatthe2015USPMembership Meeting. u


USP Science

In Pursuit of Modern, Comprehensive CompendiaIn the following Q&A, Dr. Praveen Tyle, new USP executive vice president and chief science officer, provides his vision for USP–NF, his take on the value of standards and challenges facing USP in its standards-setting activities.

Q: USP–NF have been transformed over nearly 200 years to reflect modern realities and the evolution in the way medicines are produced and delivered to patients. In what

direction do you see USP–NF headed at this stage, and what do you hope to bring to that direction?

A: USP’s ultimate goal—for USP–NF and for its other com-pendia—is to provide a public standard for every article in commerce. This has advantages for all parties, including economic benefits and, most important from our perspec-tive, public health benefits. I will add that the organization is equally concerned that USP’s standards are up-to-date and reflective of modern expectations—from using current technology employed across the pharmaceutical industry to addressing present-day challenges and threats, such as economically motivated adulteration.

Regardingthelatter,amajorfocustodayismodernizingcurrent monographs. In particular, we are looking to make the assay and identification tests in monographs more specific, stability-indicating and better capable of indicating adulteration. This approach is practical and efficient, and also better protects patients, in that greater specificity does not put us in the position of chasing every potential adulterant. That would be a losing battle—adding an endless number of tests to confirm the absence of x or y adulterant. Beyond the expense, it does not take into account the next adulterant lurking around the corner. Better describing what a substance is, as opposed to what isn’t there, is what we are seeking to accomplish. We additionally must ensure that general chapters reflect current industry practice and provide effective technology for assessing the quality of drugs, excipients and packaging materials.

In the area of missing monographs—probably our most formidable challenge—USP would greatly benefit from in-creased industry engagement. I would appeal to our industry colleagues to encourage them to donate monographs and reference materials. There are tangible benefits for com-panies in doing so, as their in-house standard becomes the basis for the eventual public standard to which they will have to comply. USP has increasing capabilities for developing standards without innovator donations, but that traditional model is straightforward and offers benefits to all.

Q: What do you see as the true value of a USP standard?

A: USP’s public standards allow independent parties to assess the quality of pharmaceutical ingredients, products and excipients—without the need to turn to either the U.S. Food and Drug Administration (FDA) or the innovator/generic that produces the material—by providing a publicly agreed upon specification (the monograph and its tests and accep-tance criteria) and materials to verify those specifications are met. With more materials coming from overseas and the ever-increasing complexity of the supply chain, there is an escalating need for independent tests, specifications and materials to help ensure consistent quality that the American public expects. We cannot compromise on such attributes when these products are being commercialized within our borders.

Q: What are the biggest challenges for USP–NF?

A: I see two main challenges. The first is the large number of monographs that require modernization, which I have discussed. The other is how to handle missing monographs when our donors, mostly the innovator industry, have resource and financial constraints. This is the more challenging task.

Q: How can USP address these challenges?

A: While USP is more equipped now than ever before to work independently to update the compendia, the organization’s needs are also as great as they have ever been. As such, we want to explore partnerships with our industry stakeholders and FDA. For example, working with these parties on modernization of both prescription and over-the-counter monographs for drug substances, and to obtain monographs and methodologies for drug products and their components where none exists now. This also encompasses updating and adding new general chapters to include key technologies that either are not well described or are completely absent from USP–NF, to ensure that we are enabling the right technology and not hindering innovation or novel testing procedures. We are also developing our contacts with manufacturers to help them understand the role that missing monographs play in potentially jeopardizing public health.

Praveen Tyle, Ph.D.

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Q: Globalization and adulteration have received the attention of Congress, FDA and various watchdog groups. How can USP standards play a role as concerns about poor-quality medicines mount?

A: There are various ways: up-to-date monographs and reference materials so the standards are public and verifi-able; guidelines that assist with distribution in a global supply chain per General Chapters <1079> Good Storage and Shipping Practices and the new draft <1083> Good Distribution Practices—Supply Chain Integrity; workshops on hot topic areas such as supply chain integrity to get maximum industry and regulatory input into how USP should play in these areas; and spectral library work to potentially provide some immediate screening capabilities to assist in identifying items that should be removed from commerce.

Q: As their role in law is far more limited, what do you see as the benefits of the Food Chemicals Codex (FCC) and the

USP Dietary Supplements Compendium (DSC), and are there evolutions taking place in these compendia as well?

A: These compendia play a key role in establishing standards for food ingredients and dietary supplements. While voluntary (unless a dietary supplement is labeled “USP”), DSC monographs set a standard for quality that should be aspired to and allow independent parties to assess off-the-shelf materials against the USP standard of quality. While FCC is not an “official compendium” in the United States, it is recognized and is enforceable in more than 200 U.S. regulations and in other countries. USP is continuing to assess these compendia and, with dietary supplements, is considering broadening the scope to include traditional medicines marketed outside of the United States. With FCC, USP is evaluating ways to extend the reach and appeal of this compendium so manufacturers and others see it as an authoritative source for quality standards for food ingredients and will want to comply with these standards to demonstrate their materials are of the highest quality. u

In response to issues initially raised by stakeholders from the biotechnology community, USP has developed a proposed new general chapter on particulate matter for biopharmaceutical injections. Particulate matter in injections consists of undissolved particles (other than gas bubbles)that are unintentionally present in a drug product. Proposed new General Chapter <787> Subvisible Particulate Matter in Therapeutic Protein Injections will be published in Pharmacopeial Forum 38(3) [May–June 2012].

General Chapter <787> has been developed as an alternative to General Chapter <788> Particulate Matter in Injections. When General Chapter <788> was first developed for USP–NF, it was designed to address the control of subvisible particles associated with small molecule injections. General Chapter <787> specifically addresses the unique requirements of therapeutic protein injec-tions. However, either chapter can be used by manufacturers.

General Chapter <788> outlines two procedures for quantifying particulate matter in small molecule drug injections—a light

Proposed General Chapter Addresses Subvisible Particulate Matter in Therapeutic Protein Injections

obscuration method and a microscopic analysis method. While light obscuration is the preferred method when addressing biologics, the method as outlined in <788> poses some technical hurdles for biopharmaceuticals. For example, biologics are typi-

cally delivered as viscous, highly concentrated formulations that can trap air bubbles if they are not handled properly. This, in turn, can lead to inaccurate particulate matter readings.

“Another concern with many protein therapies has to do with factors that can lead to aggregation, breakage or agglomeration of a drug product,” said Dr. Desmond Hunt, USP senior scientific liaison. The method outlined in General Chapter <788> allows for sonication to remove air bubbles. While sonication works well for

small molecule injectables, it may be problematic for therapeutic proteins. “Sonication can, through a number of mechanisms, lead to artificially high particulate matter readings. The hope is that this proposed new general chapter will help address some of these issues, especially as more biologics enter the therapeutic market,” explained Dr. Hunt. u


USP Science

For the first time, key players in the aerosols industry came together to discuss the challenges and limitations surrounding orally and nasally inhaled medicines during a workshop at USP headquartersinRockville,Md.,December12–13,2011.Withanemphasis on new and revised USP standards of interest to the aerosol community, the workshop also focused on technologies used to measure the quality of orally and nasally inhaled drug medications. These drugs are well accepted in the treatment of local nasal and lung diseases. USP is expanding its work in this area.

USP has defined the taxonomy of the pharmaceutical dosage forms and classified the dosage forms based on the route of administration. The taxonomy has three tiers: the first is the route of drug administration (e.g., topical), the second is the type of the dosage form (e.g., tablet) and the third is the type of the drug release (e.g., immediate release). Aerosol products can be particularly difficult to set standards for as most of them do not technically become a drug until they are released from their containers. General Chapter <5> Inhalation and Nasal Drug Products—General Information and Product

USP Proposes New Standards for Orally and Nasally Inhaled MedicinesQuality Tests focuses on product quality tests such as identification, assay, and impurities for inhalation and nasal drug products. This is a new general chapter designed to be a companion to General Chapter <601> Product Performance Tests—Nasal and Inhalation Aerosols, Spray and Powders. This general chapter focuses on the product performance tests for these products and includes aerosol particle size determina-tion and delivered-dose uniformity. Quality tests assess the integrity of the dosage form, whereas performance tests assess drug release and other attributes that relate to in vivo drug performance. Taken together, quality and performance tests ensure the identity, strength, quality and purity of the pharmaceutical dosage form.

Dr. Anthony Hickey, a member of the USP General Chapters- Dosage Forms Expert Committee, noted that these general chapters are not an attempt to replace or add to regulatory requirements, but rather aid in assessing the quality and performance of these products. Comments on the general chapters are currently under review by the Aerosols Subcommittee of the Expert Committee. u

USP Identification Tests to Be ModernizedAs USP’s monograph modernization efforts continue to move forward, identification tests are a key consideration for many USP–NF monographs slated to incorporate more modern methods. When looking at the quality of a medicine or its components, an identification test truly is the first barrier for determining if that product has been adulterated or is considered to be counterfeited. Compendial identity or identification tests verify the identity of articles as they are purported to be, and fail-ure to meet the requirements of all specified procedures of a test means that an article is mislabeled and/or adulterated. In brief, once a product fails an identification test, there is no reason to proceed with any further testing for strength, quality or purity.

Due to its wide-reaching impact on modernization, General Chapter <191> Identification Tests—General is a high priority for the USP General Chapters-Chemical Analysis Expert Committee. Mentioned in hundreds of monographs, <191> is one of the top 10 most-referenced general chapters in the USP–NF. In light of the general chapter’s link to adulterated and counterfeit product identification, the U.S. Food and Drug Administration (FDA) also has taken a strong interest in revision activities for <191> and has made it a priority for an existing FDA-USP working group dedicated to modernization.

When applying identification tests to pharmaceutical products, traditional methods have relied heavily on wet chemistry tests (e.g., acid-base testing, precipitation tests and complex formation) or classic flame tests (e.g., tests for the presence of sodium, potassium, calcium and others). What many of these tests have

in common is that they rely on human observation of properties like color, making them highly subjective and, thus, less reliable.

Over time, 44 identification tests have been incorporated into GeneralChapter<191>.Nineteenofthe44testsinvolvesub-stances now considered to be unsuitable due to environmental or safety concerns (e.g., chloroform in bromide identification). Ratherthanreviewing—andpossiblyrevising—thesetestsoneat a time, the Expert Committee is taking a more comprehensive approach to their evaluation. One possible direction would be to look at instrumental procedures that could replace traditional identification procedures.

Given the large variety in size, capability and resources among pharmaceutical and related companies, USP is aware that not all are in a position to readily adopt instrumental approaches for identification. In fall 2011, USP surveyed current needs and practices of manufacturers. Of approximately 400 responses, a majority (92 percent) reported using wet chemistry for identification, with 64 percent of those also using additional testing methods. When asked to explain how General Chapter <191> could be improved or modernized, 68 percent provided feedback, with the most common suggestion pointing to addi-tion of modern techniques or clarifying procedures.

ResultsofthesurveywillhelpshapeUSP’sthinkingaboutfuturerevisions to General Chapter <191>. A new Expert Panel will be charged with evaluating the results of the survey and providing recommendations to the Expert Committee on ways to move forward. u

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Adulteration of Foods and Dietary Supplements Workshop Examines Current Vulnerabilities, the Role of Standards

To meet modern-day tastes and demands of consumers, the food and dietary supplement industries are accelerating global sourcing and manufactur-ing while utilizing increasingly innovative, functional and natural ingredients. As the complexity of supply chains grows with more distant sourcing of ingredients, so do the risks posed by adulteration. The extent of adulteration, the emergence of promising detec-tion techniques and the role that

quality standards can play were among the areas of focus of a USP workshopheldNovember16–17,2011,inRockville,Md.

Discussions about the scope of adulteration in the dietary supplementsarenakickedoffthemeeting,withDr.RichardKo of Herbal Synergy pointing to the various mechanisms of contamination that exist—including the addition of pharma-ceuticals or other artificial ingredients, and substitution with different herbs or the same herb with inferior quality. He also provided real-life examples of the dire harm that adulterated supplements can pose to consumers, refuting the notion that this does not represent a serious public health problem.

Dr. Amy Eichner of the U.S. Anti-Doping Agency impressed upon the workshop’s largely industry audience the consequences to athletes (and all consumers) of adulterated supplements, and whymanufacturersintheaudience“needtocare.”Notingthatthese supplements are “next to your good product” on store shelves, Dr. Eichner said that adulterated supplements are not the fringe problem that many want to portray them as. Using the example of methylhexaneamine, which, although banned, is used in many sports supplements and often labeled as geranium oil, she said such adulteration is rampant.

Dr. Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs, further stressed the need for industry to take this problem seriously and join FDA in its work. Dr. Fabricant pointed to weight loss, sexual enhancement and body-building supplements as the most frequently adulterated products, and described increasing vigilance by the agency. Dr. Fabricant further spoke of the sometimes flagrant advertising of illegal ingredients and the need for responsible segments of industry to report bad players, noting that he saw anabolic steroid ingredients being promoted at a booth at a major industry trade show.

Teeing up the issue of adulteration in food ingredients, Dr. Jonathan DeVries, chair of USP’s Food Ingredients Intentional

Adulterants Expert Panel, said that food adulteration is typically economically motivated. He offered an overview of current work and future topics to be tackled by the Expert Panel. The panel is seeking to prioritize new and revised monographs based on risk, with identified vulnerable ingredients including stevia-based sweeteners, natural colors, infant formula ingredients, cocoa powder, sea salt and others. A current major initiative of the panel is one focused on skim milk powder. This ongoing USP-industry collaborative research project, through a USP advisory group, is evaluating the utility of different rapid non-targeted methods for discriminating authentic/pure skim milk powders from those that have been adulterated. The intention of this project is to create a tool box of rapid authentication methods, confirmatory methods, and new total protein methods along with reference materials to help prevent economically motivated adulteration of skim milk powder.

Otherspeakerscoveredauthenticityoffoodingredients.Newapproaches for possible food ingredient standards in the Food Chemicals Codex (FCC) for juice concentrates—in particular pomegranate juice concentrate—spices and natural colors were presented and discussed in detail. Quality standards to define the authenticity of food ingredients remain one of the ongoing chal-lenges to the food industry and a major opportunity for FCC.

The second day of the workshop was principally dedicated to the range of analytical approaches being employed to detect adulteration, including quantitative nuclear magnetic reso-nance, which may be used as a targeted approach for identifying known adulterants and non-targeted approach for unknown constituents; high-performance thin-layer chromatography, an automated technique that can be used qualitatively and quanti-tatively to detect adulterants; and chromatographic fingerprint-ing, which includes multiple techniques for authentication including microscopic, chemical and genetic. The second half of the day included two breakout sessions, one focused on dietary supplements and one focused on food ingredients, to discuss specific needs of these segments and recommendations for how USP can play a valuable role.

Closing the workshop, USP summarized suggestions that emerged from the breakouts. For dietary supplements, these ranged from creating a general information chapter describing methods and tools to screen for adulterants, to various ways to enhance USP’s monographs, to modifying USP’s verification program to include screening for adulteration, particularly in sports supplements. For foods, ideas included partnering with other groups (e.g. trade associations, government agencies) to exchange information, to establishing a mechanism for sharing analytical methods within industry (e.g. using the skim milk powder project as a model), to holding recurring workshops on adulteration. Look to upcoming issues of The Standard for updates on this work. u

FDA’s Daniel Fabricant discussed adulterated dietary supplements.


USP Science

With strong consumer interest in probiotics—and new manufacturer innovations for incorporating these ingredients into a broader array of food products—new standards to help ensure the quality of probiotic food ingredients were proposed in December 2011. The draft stan-dards, which will be included in the Food Chemicals Codex (FCC), offer comprehensive information that is essential when utilizing probiotics as food ingredients, including testing to confirm the identity upon which probiotic product safety and health claims are based.

Essential quality specifications such as identification and enu-meration (microbe count), as well as intended uses in food, safety, regulatory status, and purity of probiotics and other microbial food cultures, are included in the new FCC Appendix, titled Microbial Food Cultures Including Probiotics. These specifica-tions were proposed in the December FCC Forum.

Proper identification with probiotics is important because safety studies are most often based on the genus/species or strain level, so it is critical that manufacturers know exactly which microorganism they are incorporating into their food product to ensure safety. Identification also is important in supporting purported health claims. Given that many different strains of microorganisms are cultured and have been tested and used in foods, any supporting studies for justifying health claims are at the specific strain level. For any claimed health benefit, manufacturers should be able to confirm that what they are using in a probiotic food product is indeed the strain tested. Enumeration is similarly important because any claimed health effects supported by study trial data would also be specific to the level of intake.

Future standards development work at USP will potentially include individual monographs for specific probiotic strains, combined with more prescriptive details for identification and enumeration of the microorganisms of interest. USP will be hosting a workshop with the Institute of Food Technologists

Critical Quality Considerations for Probiotics and Other Microbial Food Cultures Offered in New Draft FCC Standards

on May 9–10, 2012, to ascertain stakeholder needs to drive its future standards work. More information is available at www.usp.org/meetings-courses/workshops.

Other proposed standards in the FCC Forum included:

Steviol Glycosides—Newstandardsforthepopular natural stevia sweeteners. An FCC monograph forhigh-purityRebaudiosideAalreadyexists, but the new Steviol Glycosides monograph covers a broader range of stevia-derived ingredients including mixtures of different steviol glycosides, which are being increasingly utilized in foods and beverages. An important component of the standard is a newly developed method capable of separating and measuring all nine glycosides, which has been difficult in the past. USP will have seven reference standards to support the monograph in the future.

Benzoates—Modernized standards for three benzoates to help address concerns about economically motivated adulteration. Widely used as preservatives, the three ingre-dients—calcium benzoate, potassium benzoate and sodium benzoate—were modernized with more specific identification tests and/or assay tests. In sourcing commercially available samples of calcium benzoate, USP laboratory staff was able to detect the adulteration of a commercial sample of allegedly pure calcium benzoate with calcium propionate by using the modernized monograph’s purity criteria. This is the goal of modernizing such monographs—to create effective tools to deal with the threat of economically motivated adulteration by better specifying what should be present without testing for specific known adulterants.

Infant Formula Ingredients—Continuing a commitment to develop monographs for infant formula ingredients, standards were proposed for chromic chloride and sodium selenate anhydrous—sources of minerals chromium and selenium, respectively, used in baby formula. This follows the addition of a variety of infant formula ingredients in the FCC over the past several years. For these infant formula ingredients, no known standards exist in any other compendium. u

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USP International

Global Public Health View, Flexible Standards-Setting Approach Drive New Compendium

In the following Q&A, Dr. Srini Srinivasan, USP executive vice president, inter-national sites and standards, explains how the USP Medicines Compendium may benefit developing countries and advance harmonization.

Q: What does USP envision as the ultimate use—and benefit—of the USP Medicines Compendium?

A: USP envisions, and is developing the USP Medicines Compendium (MC) as, a compendium for use by manufacturers and regulatory agencies around the globe. Its uniqueness lies in the fact that the performance-based monographs specified in the compendium, along withUSPReferenceStandards,allowgreaterflexibilitythatmanufacturers might use to demonstrate conformance to publicstandards.Regulatoryagenciesindevelopingnations,many of which have resource constraints, can use these standards for determination of conformance to acceptable and safe public standards. This is further facilitated by the commitment of USP to ensure ongoing availability of its reference standards. USP hopes to provide public standards in MC for all those drugs and drug products that are legally marketed in developing nations—even those where no standards exist in any of the major pharmacopeias. The independent nature of the compendium supports manu-facturers who are exporting to other developing nations by citing conformance to MC standards.

Q: Why is it important for USP to develop standards at the international level?

A: Major pharmacopeias in developed nations generally focus their attention on establishing public standards for drugs that treat diseases most relevant to their populations. In less-developed countries, due to resource constraints, national pharmacopeias have fallen behind in the establish-ment of public standards, even for drugs that are on the World Health Organization’s Essential Medicines List. Further, when documentary standards are not supported by the ready availability of reference standards for con-formance assessment, regulatory control of spurious and counterfeit drugs becomes a difficult task. Due to the global nature of MC, the focus is on establishing public documen-tary and reference standards for chemical and biological medicines that are relevant to diseases prevalent in all countries, with a priority on those under-served nations.

Q: How does MC fit in with USP’s domestic activities (specifically USP–NF)? Are there synergies among the compendia?

Srini Srinivasan, Ph.D.

A: Although MC is focused on drugs approved outside the United States, the systems and processes used in the compendium derive their strength from USP’s extensive history of setting standards for more than 190 years. The process by which documentary and reference standards are established is the same as that of USP–NF. The Expert Committee responsible for MC is an integral part of the USP Council of Experts. MC generally relies on USP–NF for non-monograph text such as general chapters. The reference procedures and impurity standards developed for MC have the potential to be introduced into USP–NF. The procedure development processes developed for MC could find direct application in modernization efforts that are underway in USP–NF. Many of the unique needs of MC have provided a new perspective that may better allow us to identify and correct gaps in USP–NF monographs and general chapters. Ultimately, MC and USP–NF each provide opportunities to inform and improve the other in synergistic ways.

Q: In what direction do you hope to take MC?

A: USP hopes that MC will provide credible public standards for chemical and biological medicines, and reference stan-dards for drug substances as well as process and degradation impurities of concern—all of which will contribute to protecting public health. Until this point, MC has focused on drug substances and some drug products available in the marketplace. In the near future, MC will be moving to incorporate excipients monographs and reference standards. USP also hopes that manufacturers that are exporting drug substances and products to other countries will adopt MC standards for their registration for market access purposes, thus providing regulatory agencies in those countries with a tool to combat the ever-increasing menace of counterfeit and substandard drugs. MC’s purpose will have been achieved when more and more regulatory agencies around the globe accept these standards.

Q: MC has been billed an “experiment” by USP. What is meant by that, and why is this experiment necessary?

A: The term “experiment” was used initially because MC was the vehicle to test our concept of a performance-based monograph that includes tests, criteria-based procedures, acceptance criteria, a reference procedure (including reference materials suitable for use as comparison standards


USP International

in MC tests and assays) and acceptable procedures. The performance-based monograph differs from the traditional USP approach, which relies on a sponsor-supplied analytical method with validation data. The feasibility of developing a reference procedure that is independent of the source of the drug substance tested needed to be assessed in the labora-tory for various articles. The feasibility studies established that reference procedure development is indeed viable and found to work satisfactorily and acceptable to the Expert Committee that authorizes MC monographs for final publication.

Q: Is there anything you’ve learned since launching MC that you’ve been surprised by?

A: Indeed, we have learned a lot during this process. Whenever you have the opportunity to consider all the underlying assumptions of the rules and processes of a pharmacopeia that has grown and changed dramatically over the past 190 years, there are bound to be surprises. We have found that we are working with a completely different group of users than with USP–NF. These users have not had the benefit of years of experience to fall back upon, and therefore, we have found that the educational needs are much greater for MC than for USP–NF. We have found that starting an Expert Committee in another country was no more difficult than forming a new Expert Committee in the United States. However, we discovered that certain policies relating to

the impurities, performance standards for the oral solid dosage forms and the details of the performance-based monographs have needed a great deal of attention and time for development.

Q: How does MC support not only USP–NF but also the other pharmacopeias of the world?

A: The performance-based monographs that characterize MC may, in our opinion, provide the most effective means to achieve global harmonization. MC standards are freely available to all pharmacopeias of the world for consideration or incorporation as appropriate. MC is also dedicated to creating reference standards for process impurities and degradation products for every drug substance monograph. These standards have parallels in pharmacopeias that do not have the infrastructure or resources to create these stan-dards. These reference standards create the basis for global comparisons of drug substances. The monographs provide modern methods for regulatory testing that are designed and intended to be broadly applicable to a wide variety of synthetic processes. As we are in the process of continually revising existing USP–NF monographs, the MC monograph approach is under consideration for use in USP–NF. Since MC is a web-based publication free for all users including regulatory agencies and other pharmacopeias, USP will encourage other pharmacopeias to consider adopting MC monographs into their national pharmacopeias. u

USP Collaborates with FDA, IPC on India CoursesIn the first offering of its kind in the country, officials from the U.S. Food and Drug Ad-ministration (FDA) joined USP in conduct-ing two pharmacopeial education courses in India in January 2012. Offered in Mumbai and Hyderabad, close to 200 professionals

attended the two-day courses on Pharmaceutical Waters.

Three FDA officials from the agency’s India office participated intheprogram—Ms.ReginaBrown,policyanalyst,Mr.MichaelCharles, investigator, and Dr. Albinus D’Sa, deputy country director. Both FDA and USP have a strong presence in the country, and cooperation on the courses resulted from discus-sions about how the two groups could work together.

The quality of source water used in pharmaceutical manufac-turing is a key area of concern for FDA, which is why it was chosen as the focus of the first course. Several other topics such as Good Manufacturing Practices and rapid testing procedures

have been jointly identified and may result in future educational offerings by USP and FDA.

Participants came away from the course with an understanding of the official requirements in water monographs and related general chapters in USP–NF; the impact of unit operations on water quality and chemistry; and the signs and symptoms that indicate potential contamination, among other critical areas.

In a separate partnership, USP conducted a pharmacopeial education course on Effectively Using the Pharmacopeia with the Indian Pharmacopoeial Commission (IPC) on February 2, 2012,inNewDelhi.Nearly100peopleparticipated.Thepar-ticipants gained an overview of the theory, practice, history and legal status of the Indian Pharmacopoeia and USP–NF, as well as an understanding of standards development processes. The course is a result of an existing Memorandum of Understanding (MOU) between USP and IPC. The two groups work together in a variety of other ways as guided by the MOU, including joint scientific meetings and scientist exchange programs. u

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India’s role as a leading figure in global phar-maceutical manufacturing brought together nearly 400 regulators, manufacturers and other stakeholders in global public health at the 11th Indian Pharmacopoeia Commission (IPC)-USP Science & Standards Symposium on February 22–23, 2012, in Mumbai. The symposium addressed ways that science and quality standards can help ensure good quality medicines in India and throughout the world.

The symposium focused on two important areas for India’s pharmaceutical sector—global quality standards for biologic medicines and supply chain management. Also highlighted were efforts related to the USP Medicines Compendium (MC)—USP’s free, online compendium comprising quality standards for medicines moving in interna-tional commerce.

The meeting was part of a continuing USP effort with the government of India and the IPC to promote access to good quality medicines—not only those being exported but also those intended for the people of India. Coincident with the 11th Symposium, USP and IPC also hosted additional meetings, including joint conclaves between the two pharmacopeial bodies and meetings of the Expert Committee responsible for MC.

Co-sponsors for the symposium were the Association of Biotechnology Led Enterprises, the Bulk Drug Manufacturers Association, the Indian Drug Manufacturers Association, the Indian Pharmaceutical Association and the Organization of Pharmaceutical Producers of India.

The event opened with a keynote address delivered by Mr. Pankaj Patel, chief executive officer of Zydus Cadila, and a guest lecture by Mr. K.V. Subramaniam, chief executive officer of RelianceLifeSciences—apartofRelianceGroup,oneofIndia’slargest private sector enterprises. Mr. Subramaniam discussed biosimilar products—biologic drugs manufactured to be similar in therapeutic impact to innovator products—and the role that

Global Quality Standards for Biologics and Supply Chain Management the Focus of Mumbai Meeting

Indian manufacturers play in today’s biologics market. Other speakers on the topic of biologics included Dr. Ivana Knezevic of the World Health Organization (WHO) quality and safety of biologicals group, presenting on WHO’s approaches to biologicandbiosimilarmedicines,andDr.NoraDellepiane,who addressed the vaccine prequalification program of WHO.

In addition to vaccines, meeting topics covered therapeutic proteins, another important class of drugs for India’s growing biologics manufacturing sector; strategic perspectives on biotechnology products in developing countries; the role of bioassays in biosimilarity; and the replacement of animal studies for potency testing of human vaccines. Speakers represented

suchorganizationsastheNa-tional Institute for Biological Standards and Control (United Kingdom),theCentralResearchInstitute (Kasauli), and the Serum Institute of India (Pune) as well as Indian manufacturers, Biocon and Biological Evans.

In a presentation track dedicated to supply chain management, speakers included USP Expert Committee members currently involved in the development of USP General Chapter <1083> Good Distribution Practices—Supply Chain Integrity. This is a first-of-its-kind USP general

chapter in USP–NF, designed to encourage comprehensive public standards on supply chain issues across the pharmaceutical industry.

Additional symposium session topics related to supply chains were cold chain management; pharmacopeial advances in packaging standards; storage and shipping of pharmaceuticals; and synergies between supply chain management and risk management. Speakers presented on behalf of various organiza-tionsincludingPfizer,Dr.Reddy’sLaboratories,BioBridge, the U.S. Food and Drug Administration (India) and the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL).Establishedin2004,PHARMEXCILhasplayed an important role in addressing trade- and export-related issues that specifically impact the Indian pharmaceutical industry, including the development of barcode technologies to help protect pharmaceutical exports from India against the threat of adulteration and counterfeiting. u

From left: Dr. Satya Dash, Association of Biotechnology Led Enterprises; Dr. Williams, USP; Dr. B. Suresh, IPC.


USP International

First Global Summit of Pharmacopeias Hosted in BeijingOrganized and hosted by the Chinese Pharmacopoeial Commission (ChP), and co-hosted by USP and the World Health Organization (WHO), the first-ever Global Sum-mitofthePharmacopeiastookplaceinBeijing,China,fromNovember17–18,2011.

Representativesfrom16pharmacopeias—includingWHO’sInternational Pharmacopoeia—and one regulatory authority attended the inaugural event. The goal of the summit was to provide participants with an opportunity to engage in in-depth discussions on topics of shared interest, including the establishment of internationally harmonized pharmacopeias and related methods for collaboration; strengthening existing collaborations among pharmacopeias; and information-sharing mechanisms.

In attendance were Mr. Wu Zhen, deputy commissioner of China’s State Food and Drug Administration;Dr.RogerL.WilliamsofUSP;Mr.WangLifeng,secretarygeneralofChP; Dr. Herbert Schmidt, technical officer, quality assurance and safety: medicines of WHO; and officials from the regulatory agencies of 16 nations.

The summit began with a general introduction of each country or region’s pharmaco-peia, which included overviews on organizational structures, missions, descriptions of standardsandtheirrelationshipstoregulations.Roundtableexchangesamongpartici-pants on topics of interest included discussions on standards for biologics, Traditional Chinese Medicines, homeopathic medicines and herbal mixtures; “green” practices to support pharmacopeial standards; strategic approaches of The International Phar-macopoeia relative to other pharmacopeias; harmonization benefits and challenges; interchangeability of analytical instrument methods; and monograph updating and development.

Additionally, Dr. Williams provided an overview of the USP Medicines Compendium —USP’s free, online compendium comprising quality standards for medicines moving in international commerce. Mr. Wang Ping, deputy secretary general of ChP, discussed a ChP proposal to develop an index of world pharmacopeial standards for drug substances and products. Follow-on actions were considered, which included an offer by ChP to host the next summit in China in conjunction with the biannual scientific symposium hosted by USP and ChP in late 2012.

At the end of the summit, a majority of the participants reached an agreement to continue pursuing global pharmacopeial collaborations through the promotion of safe medication and quality standards, establishing the Global Summit of the Pharmacopeias as a platform for continued dialogues and effective collaborations among pharmacopeias. The second summitisplannedforSeptember2012inXian.u

Representatives from 16 pharmacopeias took part in the summit.

Participating organizations and their pharmacopeias were:

Administración Nacional de Medicamentos, Alimentos y Technología Médica – Argentine Pharmacopoeia

Agência Nacional de Vigilância Sanitária – Brazilian Pharmacopoeia

British Pharmacopoeia Commission – British Pharmacopoeia

Chinese Pharmacopoeial Commission – Chinese Pharmacopoeia

European Directorate for the Quality of Medicines & HealthCare – European Pharmacopoeia

Federal Institute for Drugs and Medical Devices – German Pharmacopoeia

Indian Pharmacopoeia Commission – Indian Pharmacopoeia

Indonesian Pharmacopoeia Commission – Indonesian Pharmacopoeia

World Health Organization – International Pharmacopoeia

Ministry of Health, Labour and Welfare/Pharmaceutical and Medical Devices Agency, Japan – Japanese Pharmacopoeia

Republican State Enterprise National Centre for Expertise of Drugs, Medical Products and Equipment – State Pharmacopoeia of the Republic of Kazakhstan

Comisión Permanente de la Farmacopea de los Estados Unidos Mexicanos – Mexican Pharmacopoeia

Saudi Arabia Food and Drug Administration

Bureau of Drug and Narcotic, Department of Medical Sciences – Thai Pharmacopoeia

State Administration of Ukraine on Medicinal Products – Ukrainian State Pharmacopoeia

United States Pharmacopeial Convention – United States Pharmacopeia–National Formulary

Vietnamese Pharmacopoeia Commission – Vietnamese Pharmacopoeia

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International Exchange Furthered with USP Japan TripProfessional, Cultural Highlights Mark Trip for USP’s Kevin Moore

As part of continued efforts to strengthen and expand upon USP’s relationship with the Japanese Pharmacopoeia (JP) and related regulatory and industry groups, Dr. Kevin Moore, USP scientific liaison, spent 10 days in Japan this past winter. Dr. Moore is USP’s primary contact with JP in trilateral harmonization activities that also include the European Pharmacopoeia (under the Pharmacopeial Discussion

Group, or PDG). The trip was unique for USP and focused on learning more about these organizations and ways that USP can improve its collaborations with them. Dr. Moore learned firsthand about Japan’s Pharmaceuticals and Medical Devices Agency’s (PMDA), its structure and culture, as well as about the Japan Pharmaceutical Excipients Council (IPEC–Japan), and numerous other laboratories, universities and organizations.

Dr. Moore’s trip began in Tokyo with a meeting of IPEC–Japan. There, Dr. Moore learned about the makeup of the group, its eight committees and its function within the Japanese phar-maceutical industry. Dr. Moore also met with representatives from JP who participate in PDG and addressed issues of mutual importance.Laterinhistrip,Dr.MoorevisitedtheNationalInstituteofHealthSciences(NIHS)inTokyo,thePMRJLabora-tory in Osaka, Kyoto University, and the Pharmaceutical Society of Japan to hear about their activities and provide background information on USP.

Mr.NobuoUemura,whospent16monthsatUSPasPMDA’sInternational Liaison officer, hosted Dr. Moore for part of the trip and the two attended several cultural events, including two baseball games —one in Tokyo and one in Osaka. Baseball is a common interest of both Dr. Moore and Mr. Uemura, and during Mr. Uemura’s time at USP they attended a few Wash-ingtonNationalsgamestogether.Dr.Moorewasquitetakenwith the vast differences between the atmosphere of American and Japanese baseball. In Japan, the crowd was almost always engaged in team chants, with each player having his own personalized chant with different musical accompaniments.

Toward the end of his trip, Dr. Moore was the guest of Dr. Shigenori Harada, who was previously the PDG representative from PMDA, now retired. Highlighting the deep importance of the USP-PMDA relationship, Dr. Harada remarked that the letter sent to him by USP upon his retirement was framed on his desk at home. The Jidai Matsuri Festival was also a highlight for Dr. Moore. The festival, which celebrates the founding of the capital in Kyoto approximately 1,200 years ago, featured a parade of traditional Japanese costumes throughout history. It lasted ap-proximately five hours and included roughly 2,000 performers.

USP is currently hosting Dr. Tetsuya Kusakabe from PMDA. Dr. Kusakabe has been at USP since August 2011 as the Interna-tional Liaison officer, the role previously held by Mr. Uemura. u

Chile and USP Strengthen Ties, Commitment to Quality MedicinesFurther strengthening their mutual commitment to improving the quality and safety of medicines in Chile and in the United States, the Chilean Phar-macopoeia Foundation (CPF) and USP signed a Memorandum of Understanding (MOU)inNovember2011.TheMOUis designed to increase awareness of the importance of the quality and safety of medicines; promote cooperation between CPF and USP; and identify areas of mutual interest and potential collabora-tion. Professor Marcela Escobar, CPF’s directorypresident,andDr.RogerL.Williams, USP’s chief executive officer, signed the MOU during aceremonyatUSP’sheadquartersinRockville,Md.

“The pharmaceutical industry has grown into a complex global network, making partnerships between official standards-setting bodies increasingly important to help ensure the quality of medi-cines,” said Dr. Williams. “I am pleased to further strengthen

this network by formalizing our partner-ship and look forward to working with CPF in efforts to protect and improve public health.”

“Chile and the United States share the common goal of improving the quality of medicines in both of our countries, and in the region, and it is our hope that this partnership will help us do just that,” said Professor Escobar. “This is an exciting alliance and one that I am certain will be fruitful for both pharmacopeias and the patients and practitioners we serve.”

The MOU details potential areas of collaboration between the two pharmacopeias such as the development of reference mate-rials for testing to demonstrate compliance with pharmacopeial standards; adoption or adaptation of USP–NF and the Chilean Pharmacopeia; and the exchange of scientific staff and informa-tion through programs such as joint meetings and courses, visiting scientists and publications. u

USP’s Dr. Williams and CPF’s Professor Escobar sign the MOU in Rockville, Md.

Kevin Moore, Ph.D.


USP was greeted by a tribal delegation in Ghana in a ceremony full of tradition.

USP International

USP-Africa Center Continued from front cover.

A 2009 report by the U.S. Agency for International Development (USAID) and USP pointed to the ubiquity of poor-quality medicines. In it, roughly one-third of the selected antimalarials in three African nations tested was found to be substandard. Such medicines result in severe patient outcomes including death, and additionally contribute to the growth of drug-resistant disease parasites.

CePAT is the outcome of a pilot Technical Assistance Program (TAP) that USP launched last year in six countries. Under the program, USP provided trainings as well as its documentary and reference standards for free or at reduced pricing. During a regional training session in Ghana with the national laboratories of five participating African countries, it became clear that there was a need for a more permanent presence that could deliver training on-demand,tailoredtolocalneeds.“RatherthanhavingUSPemployees from the United States conduct isolated courses on specific topics, we believe a more sustainable approach is to train local experts, fostering a knowledge base and thus equip-ping African chemists to further train others to create a lasting regional solution,” explained Mr. Hendrix.

USP has worked in specific African countries through grants from USAID (the Promoting the Quality of Medicines, or PQM, program and predecessor programs) for decades, and the center will complement and build upon this work. This will mark a significant scaling-up of independent USP activity in the region. While the USAID grants have allowed USP to make tremendous strides in advancing the quality of antimalarial, antituberculosis and antiretroviral medicines, CePAT will not be limited to medicines treating those diseases but will focus on stimulating systemic changes that can be sustained locally.

“One of the key challenges the development community faces is that most programs are based on ‘vertical’ funding—meaning it is disease-specific. With CePAT, we intend to transcend this sort of model, strengthening the infrastructure of countries as a whole so our work will impact all medicines,” noted Dr. Patrick Lukulay, USP vice president of global health impact programs.

USP’s $1.5 million pledge will supplement funding from outside donors to cover construction, instrumentation and staffing costs, and to subsidize local use of the center for the first three years. Based on external funding obtained and other relevant factors, CePAT will be subject to final Board approval. USP expects the center to become self-sustaining after three years through the variety of services it will provide to local manufac-turers, regulators and others. These are envisioned to include trainings on topics such as quality control and current Good Manufacturing Practices; quality control testing services for donor agencies, procurement organizations or local manufac-turers; and consulting services on supply chain integrity and laboratory design, among other offerings.

Africa Trip

USPleadership,includingDr.RogerL.Williams,chiefexecutiveofficer; Mr. Hendrix; Dr. Srini Srinivasan, executive vice presi-dent, international science and standards; Ms. Angela Long, senior vice president, global alliances and organizational affairs; and Dr. Lukulay, laid local groundwork for the center during a weeklong trip to Africa in December 2011. The group visited three countries—Ghana, South Africa and Ethiopia—meeting with government officials and other key stakeholders to introduce the concept, seek input and explore possible partner-ships. Across these meetings, the idea was greeted with much enthusiasm.

The trip commenced in Ghana, where the USP team was welcomed by a tribal delegation in a ceremony full of tradi-tion. This included acrobatics, dancing, fire-eating and the presentation of kente cloth. USP donated five laptops to be used in local schools. Following this ceremony, the group took time to explore some of the country’s history, including a visit totheinfamousElminaCastleandits“DoorofNoReturn.”Established in 1482, this was a major trading outpost in the Atlantic Slave Trade for roughly three centuries.

While in Ghana, the group met with key officials in the country, including The Honorable Joseph Yieleh-Chireh, former minis-ter of health; Major General Smith, minister of defense; and Dr. Stephen Opuni, chief executive officer of the Ghana Food and Drugs Board. From there, the group traveled to South Africa for another series of meetings, including the Medicine Control Council. They ended the trip in Ethiopia, where they met with government officials including Minister of Health Kebede Worku and a group from the Food, Medicine and Health Care Administration and Control Authority.

According to Ms. Long, the trip enabled “face-to-face interac-tions that assist in building trust, friendship and relationships that will open the doors to meaningful collaborations. The establishment of CePAT represents the next phase in USP’s long and rich history of advancing public health, and we are very pleased to take part in what we believe will be a lasting contribu-tion to the region.” u

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PQM Program

To better ensure the quality of medicines in Ethiopia, the country’s medicines quality control laboratory—the

Product Quality Assessment Directorate (PQAD)—attained the internationally recognized ISO/IEC 17025:2005 accreditation for testing and calibration laboratories in December 2011. PQAD serves as the technical wing of the Ethiopian Food, Medicine and Health Care Administration and Control Authority (FMHACA), protecting the quality of food and medicines both before market authorization and while they are on the Ethiopian market.

PQAD’s partners that assisted the laboratory in achieving this accreditation include the U.S. Agency for International Development and the Promoting the Quality of Medicines (PQM) program in Ethiopia, which is implemented by USP with funding provided by the U.S. President’s Emergency Plan forAIDSRelief.PQMworkswithregulatoryauthoritiesindeveloping countries around the world to safeguard the quality of medicine.

ACLASS, an internationally recognized accrediting body based in Washington, D.C., awarded PQAD the ISO/IEC accreditation for seven key analytical tests. This accreditation certifies that PQAD is providing valid and trustworthy data to the Ethiopian Ministry of Health. PQAD is the first medicine quality control

PQM Assists Ethiopia in Achieving International Laboratory Accreditation

laboratory under a Ministry of Health in sub-Saharan Africa to obtain this accreditation by a U.S.-based internationally recog-nized accrediting body. While PQM has assisted laboratories in Southeast Asia and South America qualify for similar accredita-tion, this is the first PQM-assisted laboratory in sub-Saharan Africa to achieve accreditation.

“The ISO/IEC 17025:2005 accreditation positions PQAD among Africa’s elite laboratories in the area of pharmaceutical quality control,” said Mr. Denekew Yehuleu Alamneh, director-general of FMHACA. “With this achievement, we have demonstrated our ability to produce reliable results that will give authorities—within Ethiopia and internationally—confidence in decisions impacting the health of patients.”

“Much of the laboratory work essential to medicines quality testing entails complex methods and procedures that must be followed meticulously to ensure accurate results. The impor-tance of this accuracy cannot be overstated,” said Dr. Patrick Lukulay, USP vice president of global health impact programs. “With this accreditation, PQAD demonstrates that its technical operations and administrative systems are functioning at the highest quality levels by international standards, producing accurate, valid results that can be trusted by the international community.” u

PQM Establishes Medicines Quality Monitoring in Yunnan, ChinaDr. Souly Phanouvong, PQM manager, Asia programs, joined by World Health Organization (WHO) collaborators and local partners from the State Food and Drug Administration (SFDA), toured several sites in the Yunnan province of China to develop a plan for establishing medicines quality monitoring (MQM) in the region. The group met with local health authorities in Kunming, Tengchong, Bao Shan city,Yingjiangcounty,Ruilicountyand Dehong city to discuss conducting a baseline survey on the quality of antimalarial medicines in those areas.

During visits to health facilities and pharmacies, they gathered information on malaria incidence and control ef-forts at the county level, the availability of antimalarial medicines and the chal-lenges the local health and authorities are facing. The team also tried to learn if there were concerns about medicines quality and, if so, what should be done about

it. To varying degrees, malaria is still a health concern in all the cities and counties visited. In general, there were a very limited quantity and selection of antimalarials available at retail pharma-

cies and clinics or in stock at village and community health centers. Public health facilities have been challenged in implementing the malaria control program because many villagers and malaria patients still go to private pharmacies—which do not always comply with the government treatment regimen—for their medicines.

As a result of this trip, SFDA, Yunnan FDA, Yunnan Food and Drug Quality Laboratory, WHO and PQM developed a plan to conduct a base-line survey of antimalarials. It clearly defines

roles and responsibilities for each key stakeholder and will produce a

valid survey—the first step in establishing an improved MQM program in Yunnan province. u

Dr. Phanouvong conducts a visual inspection in a local pharmacy.

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Inside USP

Global Philanthropic Health Initiatives Strengthened with New USP Vice President of DevelopmentUSPwelcomedMs.ReemaJweied-GuegelasvicepresidentofdevelopmentinJanuary2012.In this role, Ms. Jweied-Guegel is leading the newly formed development department, which is tasked with making USP’s standards broadly available to all countries and obtaining philan-thropic funding to support current and future global health initiatives.

“AsUSPdevelopsitsphilanthropicefforts,aleaderlikeReemawhopossessessuchextensiveglobal experience was a natural fit,” said Mr. Brian Hendrix, executive vice president and chief operating officer at USP. “She will be building on the strong foundation USP has established with programs that help combat substandard and counterfeit medicines in developing countries and also seek philanthropic funding to help USP increase its global reach and impact. I welcome ReematoUSPandIlookforwardtoherexpertiseguidingUSP’scharitableoutreach.”

Ms. Jweied-Guegel has more than 17 years of experience in the nonprofit sector. Prior to joining USP, Ms. Jweied-Guegel served for eight years as the senior vice president at the U.S.-Jordan Business Alliance, an organization founded under the auspices of His Majesty King Abdullah II. There, she worked to further the economic relationship between the United States and Jordan through outreach to companies in key sectors. Ms. Jweied-Guegel has also served as a senior advisor to the Business Council for International Understanding as well as the executive director ofmarketingandstrategicdevelopmentattheNationalU.S.-ArabChamberofCommerce. Ms. Jweied-Guegel received her master of business administration in marketing from George Washington University, where she was inducted into the international honor society Beta Gamma Sigma. She is a graduate of the 2003 Leadership America class and currently sits on the Steering Committee for the Arab American Institute Foundation’s Khalil Gibran Spirit of Humanity Awards. u

USP Launches New WebsiteOffering faster, simpler access to a wealth of information about the quality of drugs, foods and dietary supplements, USP launched itsnewwebsiteatwww.usp.orginFebruary2012.Redesignedtoprovide updated and expanded content as well as greatly enhanced navigation, the new site provides quick access to resources tailored to volunteers, manufacturers, practitioners, patients, consumers and regulators.

Specific, new website features and updates include:

Ability to connect with USP about ways to get involved, joining in the social media conver-sation, attending USP meetings and workshops, and pharmacopeial education courses.

Significant expansion of the Mandarin Chinese, Portuguese and Spanish language versions of the website.

Elaboration of the “Around the World” section with information on USP’s international locations, regional activities, exchange programs and the USP Medicines Compendium.

Newnavigationprovidingeasyaccesstoinformationonstandards-settingactivities, international outreach and other USP public health initiatives.

Standards-setting information organized by focus: monographs for medicines, dietary supplements, food ingredients and physical reference standards.

Information sorted by role or interest: manufacturers, regulators, healthcare providers, patients and consumers, and members and volunteers. u

Documents

The Standard 2012 Winter