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IPEC QA Guide & Template –Content, application and benefit for industry
Dr. Johanna EiseleEvonik Industries AG
Amsterdam, June 2014
June 2014, Johanna Eisele, Evonik Industries AG2
• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements • IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers • Quality agreements with distributors
Agenda
June 2014, Johanna Eisele, Evonik Industries AG3
Why quality agreements?
• Beneficial in supply relationship
• Create a quality partnership
• Mutual understanding of expectations
• Know and understand products / processes involved
• Clearly defines and assign quality responsibilities and activities
• Based on quality procedures in place
• In some jurisdictions required for manufacturing under contract
June 2014, Johanna Eisele, Evonik Industries AG4
• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements • IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers • Quality agreements with distributors
Agenda
June 2014, Johanna Eisele, Evonik Industries AG5
Regulatory requirements
EU:• EMEA refers to a quality agreement as a „technical
agreement“• Required in legislation such as Directive 2003/94/EC (Article
12) and EU GMP Guide• Refers to contract manufacturing,
contract analyses, etc.• Does not refer to supply of goods USA:• Assumed for contract manufacturing, draft guideline May
2013
There are no legal requirements for QA between buyers and suppliers of excipients!
June 2014, Johanna Eisele, Evonik Industries AG6
EU GMP guideline -2013 draft of chapter 5
• Newly introduced Point 5.33 is about the minimal requirements concerning the subcontracting of the testing of starting materials by the manufacturers of the medicinal product to the approved starting material manufacturer
• Formal agreement should be signed between the two parties.
• Special attention should be paid to the distribution in order to ensure that the initial test results remain valid even after the transport
• (…..)No Action on this draft for some time…..
June 2014, Johanna Eisele, Evonik Industries AG7
• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements • IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers • Quality agreements with distributors
Agenda
June 2014, Johanna Eisele, Evonik Industries AG8
Objectives of quality agreements
Buyer and Supplierdefine obligations
Supplier adoptsadditional
responsibilities
Buyer and Supplieragree on joint
definition of quality with regard on
excipients supplied
Buyer adopts additional
responsibilitiesQuality agreements complement
supply/commercial agreements
June 2014, Johanna Eisele, Evonik Industries AG9
Objectives of quality agreements
Buyer and Supplierdefine obligations
Supplier adoptsadditional
responsibilities
Buyer and Supplier agree on joint
definition of quality with regard on
excipients supplied
Buyer adopts additional
responsibilitiesQuality agreements complement
supply/commercial agreements
A quality agreement does not replace the qualification or an
audit of the supplier!
June 2014, Johanna Eisele, Evonik Industries AG10
Objectives of quality agreements
Define!Why and with whom to execute quality agreements?Buyer: • Key suppliers / critical suppliers• Key materials / critical materials
Supplier:• Key accounts• Key development partners• Key external service providers
June 2014, Johanna Eisele, Evonik Industries AG11
• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements• IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers • Quality agreements with distributors
Agenda
June 2014, Johanna Eisele, Evonik Industries AG12
Negotiation of quality agreements –who should be involved?
• Quality Assurance staff of supplier and buyer• Legal department of supplier and buyer
Case to case: • Sales and Account Managers (recommended)• Regulatory Affairs• Production • Quality Control
Define: who gets in the lead for negotiations?
June 2014, Johanna Eisele, Evonik Industries AG13
What influences negotiation?
Time period of negotiation
Complexity andrichness of details
Staff involved in review
and negotiation
June 2014, Johanna Eisele, Evonik Industries AG14
What influences negotiation?
Supplier’s Q-SystemISO 9001 IPEC GMP
USP <1078>
Supplier(Manufacturer /
Distributor)Suppliers Sites, Legal counsel
QA, other Personnel
Buyer’s Q-SystemUS, EU or WHO
-GMP
BuyerBuyer Sites Legal Counsel
QA, other Personnel
Content of QA
- Complexity - Term- Sites
What influences negotiation?
• Observe consistency to existing or planned supply agreements
• Liability and liability caps should be addressed and have to be agreed on.
• A quality agreements is a fully-fledged legal contract applicable to contract partners as legal entities.
• A quality agreement is more than a contract between quality departments.
Copenhagen - September 2012, Johanna Eisele, Evonik Industries AG15
June 2014, Johanna Eisele, Evonik Industries AG16
• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements• IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers • Quality agreements with distributors
Agenda
June 2014, Johanna Eisele, Evonik Industries AG17
The IPEC QA guide and template
• To improve communication between excipient users and suppliers
• Template designed as a common starting point to create quality agreements
• Templates addresses fundamental quality issues specific to the manufacture and use of excipients
• Intended to reduce time and effort needed to complete a Quality Agreement
Download IPEC Guidance documents for free at http://www.ipec-europe.org/
June 2014, Johanna Eisele, Evonik Industries AG18
IPEC‘s quality agreement template
• Flexible model for crafting quality agreements
• Tool box “Build you own quality agreement”
• Defines appropriate topics that should be addressed in a quality agreement related to excipients.
• Manufacturer Template: Designed for use between the original manufacturer and either the end user or a distributor.
• Distributor Template: Designed for use between the distributor and the end user.
June 2014, Johanna Eisele, Evonik Industries AG19
Pitfall: parties to conclude a QA
Liability insurance terms often prevent direct quality agreements between original manufacturer and end user when the material is purchased via distributor.
Manufacturer Distributor End user
End user
June 2014, Johanna Eisele, Evonik Industries AG20
• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements• IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers • Quality agreements with distributors
Agenda
June 2014, Johanna Eisele, Evonik Industries AG21
Content of quality agreements (1)
Introduction and Purpose• Scope• Define product(s)• Define quality criteria (IPEC GMP, EXCiPACT™,
ISO 9001, USP<1078>, etc.)• Responsibilities for quality activities • Sites involved• Use of third parties• Assignment of responsibilities• Choice of Law and other legal clarification• Compliance
June 2014, Johanna Eisele, Evonik Industries AG22
Content of quality agreements (2)
• Manufacture, testing, packaging, labelling, release• Documentation and records• Storage and distribution• Change control• Non-Conformance• Auditing• Quality contacts• Clarification of liability• Signatories – authorized to sign?• References• List of attachments
June 2014, Johanna Eisele, Evonik Industries AG23
• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements• IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers• Quality agreements with distributors
Agenda
June 2014, Johanna Eisele, Evonik Industries AG24
Quality agreements with manufacturer
• Contract with the original manufacturer of an excipient
• Executed with buyer, end user or distributor
• Original manufacturer: the company that manufactures a material to the stage at which it is designated as a pharmaceutical starting material.
June 2014, Johanna Eisele, Evonik Industries AG25
Quality agreement with a manufacturer – case study
• Evonik Industries AG Product Line Pharma Polymers & Services
• Manufacture of acrylic copolymers EUDRAGIT® (excipient in oral and dermal dosage forms)
• Backward integrated for raw materials (i.e. monomers)
• ISO 9001 / 14001 / BS OSHAS, EXCiPACT™ certified
– Last ISO Certificate February 2012 (first audited 1993)
• In place and certified according to ISO 9001:
– Quality Manual, Central Audit System, Central Purchase and Supplier Evaluation, Central Analytical Department, …
June 2014, Johanna Eisele, Evonik Industries AG26
How to approach?
• As of 2004 increasing demand to sign quality agreements
• Multi-national and small companies
• In 2004 / 2005 Evonik started to elaborate: what would be the contents of quality agreements?
• Involved parties: QA, Regulatory, Representative of Account managers, Legal Department, Sales and Distribution.
• Educate the organization!
• Be resource efficient
• Flexible template is used
June 2014, Johanna Eisele, Evonik Industries AG27
• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements• IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers• Quality agreements with distributors
Agenda
June 2014, Johanna Eisele, Evonik Industries AG28
• Distributor: handles the excipient after the point at which the excipient is transferred outside the control of the original manufacturer
• Any supplier other than the original manufacturer.
Examples: • Re-processors, Re-packagers, • Transport and warehousing companies• Forwarding agents• Brokers, traders• But also distributing legal entities of the original
manufacturer.
Quality agreements with distributors (1)
June 2014, Johanna Eisele, Evonik Industries AG29
Quality agreements with distributors (2)
• Contents similar to quality agreements with original manufactures
• To be adopted for Good Distribution Practices• To be adopted depending on the activities of the distributor
(Re-packaging? Re-Labelling? Re-analysis?)• Distributor shall have quality agreement in place with original
manufacturer.
June 2014, Johanna Eisele, Evonik Industries AG30
How to prepare a quality agreement?
• Supplier may consider to prepare a quality agreement in advance based on the IPEC template
• Parties should verify if quality responsibilities may require action
• Ensure that the obligations of the agreement are consistent with the quality systems of both supplier and buyer
• Modify template with care
• Seek legal counsel
• Ensure effective implementation at both parties
• Observe life cycle of quality agreement
June 2014, Johanna Eisele, Evonik Industries AG31
Quality Agreement – Life Cycle
Expiration QA
Amendments
Staff involved
Negotiation
Signatures QA
Content QA
Contracts in place
Negotiate subsequent QA
June 2014, Johanna Eisele, Evonik Industries AG32
Summary
• Quality agreements foster a successful and trustful cooperation between supplier and buyer
• IPEC template allows to build and prepare an appropriate agreement
• Quality agreements should correctly describe actual procedures.
• Quality agreement are legally binding documents / contracts.
• Negotiation and maintenance of quality agreements involve various departments including legal.