cGMP and it’s Importance in Herbal Preparations 2010

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cGMP AND IT·S IMPORTANCE INcGMP AND IT·S IMPORTANCE IN

HERBAL PREPARATIONS.HERBAL PREPARATIONS.

Dr.Ajmal Nasir

Executive Director Technical Executive Director Technical

Highnoon Laboratories Pakistan (Pvt.) ltd Highnoon Laboratories Pakistan (Pvt.) ltd



J an 2010 Dr Ajmal Nasir

[email protected].

WHAT ARE

GMPs?

Regulations describing the methods,equipment,

Facilities,and controls to produce,

Human &veterinary products(21CFR 210-211)

Medical devices (21CFR 820)

Processed foods (21CFR 100)

In U.S called cGMP to addDynamism in expectations.




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HI I

K U

First official document in anada in 1957

current MP in 1980·s

STATUS I PAKISTAN.

riginally based upon best industry practices.

Evolved with improvement of technology

and practices.

First MP regulation in 1963.

Mandatory for Medicine & evices.

Not mandatory for Herbal Preparations.




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WHY cGMP? Q ALITY

SAFETY

EFFICACY

P RITY

CONSISTENCY

STABILITY




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BASIC ELEMENTS OF

cGMP. DEFINED Q ALITY POLICY.

Q ALITY ASS RANCE SYSTEM.

DEFINED MAN FACT RING PROCESS.

VALIDATED PROCED RES.

TRAINED Q ALIFIED STAFF. ADEQ ATE SPACE& PREMISES.

S ITABLE EQ IPMENT &SERVICES.




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CORRECT MATERIALS & PAC AGING.

S ITABLE STORAGE & TRANSPORTATION.

PROPER SANITATION & EQ IPMENT

MAINTENANCE.

PROPER MAN FACT RING RECORD.

RE CALL PROCED RE.

COMPLAINT HANDLING.

BASIC ELEMENTS OF

cGMP.




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COMMON REQ IREMENTS

OF

VARIO S cGMPS.

Proper design,maintenance and cleaning of equipment.

Written and approved operating procedures.

Independent Quality nit (Q.A / Q.C)

Committed and well trained personnel and Management.

There are differences depending on regulatory bodiesThere are differences depending on regulatory bodies

e.g Training is required by Canada, .S.and E.C GMPs.e.g Training is required by Canada, .S.and E.C GMPs.

FDA requires Annual product review . Not required byFDA requires Annual product review . Not required by

Canada.Canada.




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What are

HERBAL PREPARATIONS

(Traditional Herbal Medicines). THM

are finished drugs used for self

medication.

Documented in folkloric literature.

May contain Herbal based or

Chemically defined excepients in

addition to active substance.




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Herbal ingredients include aerial or

underground parts of plants, or other plant

material, or combination thereof, whether in crude state or as plant preparations.

Plant material may include juices, gums,fatty oils, essential oils and any other

substances of this nature.

What are

HERBAL PREPARATIONS

Contd.




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DO WE NEED TO IMPLEMENTDO WE NEED TO IMPLEMENT

SAME STANDARDSSAME STANDARDS

FORFOR

HERBAL PREPARATIONS ?HERBAL PREPARATIONS ?




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YES YES , IT IS ESSE NTIAL.

Herbals are used by same end user.

Has to be safe pure and efficacious.

As old as 5000 years back in History.

80 % of world population uses THM




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ADVANTAGES WITH cGMP

CONSISTENT QUALITY.CONSISTENT QUALITY.

BETTER CONTROL.BETTER CONTROL.

MINIMUM OF LOSSES.MINIMUM OF LOSSES.

NO REGULATORY /QUALITY ISSUES.NO REGULATORY /QUALITY ISSUES.




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G IDELINES AND STANDARDS

WHO General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine , WHO/EDM/TRM/2000.1,

WHO Geneva, 2000 (19 Swiss Francs)

Guidelines for the Appropriate use of Herbal Medicines (ISBN 92 9061 124 3), WHO Regional Publications, Western

Pacific Series No. 23, WHO Regional Office for the Western Pacific, Manila, 1998 (7.50 Swiss Francs)

Guidelines for the assessment of herbal medicines *, **, (ISBN 92 4 120863 5), WHO Technical Report Series, No.863, WHO Geneva, 1996 (35 Swiss Francs) ± these guidelines are also included in Quality Assurance of Pharmaceuticals: A compendium of guidelines and related materials, Volume 1.

Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products *, **,Annex 8 of (ISBN 92 4 120863 5), WHO Technical Report Series, No. 863, WHO Geneva, 1996 (35 Swiss Francs) ±these guidelines are also included in Quality Assurance of Pharmaceuticals: A compendium of guidelines and related

materials, Volume 2, Good manufacturing practices and inspection.

Guidelines for Training Traditional Health Practitioners in Primary Health Care, WHO/SHS/DHS/TRM/95.5, WHOGeneva, 1995

Research guidelines for evaluating the safety and efficacy of herbal medicines (ISBN 92 9061 110 3), WHO RegionalOffice for the Western Pacific, Manila, 1993 (7.50 Swiss Francs)

W HO/IUCN/WWF Guidelines on the Conservation of Medicinal Plants *, ** (ISBN 2 8317 0136 8), IUCN, Gland,Switzerland, 1993

Report of the Consultation on AIDS and Traditional Medicine: Prospects for Involving Traditional Health Practitioners

( F rancistown, Botswana, 23-27 July 1990), WHO/TRM/GPA/90.1, WHO Geneva, 1990




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Quality control of Herbal medicines

Guidelines

W HO monographs on selected medicinal plants (3 volumes) (ISBN 92 4 154517 8),WHO Geneva, 1999 (92 Swiss Francs)

Quality control methods for medicinal plant materials (ISBN 92 4 154510 0), WHOGeneva, 1998 (35 Swiss Francs)

Basic tests for drugs: pharmaceutical substances, medicinal plant materials and dosage forms (ISBN 92 4 154513 5), WHO Geneva, 1998 (26 Swiss Francs)

Guidelines for the Appropriate use of Herbal Medicines (ISBN 92 9061 124 3), WHORegional Publications, Western Pacific Series No. 23, WHO Regional Office for theWestern Pacific, Manila, 1998 (7.50 Swiss Francs)

Regulatory Situation of Herbal Medicines: a worldwide review , WHO/TRM/98.1,WHO Geneva, 1998

Good manufacturing practices: supplementary guidelines for the manufacture of

herbal medicinal products *, **, Annex 8 of (ISBN 92 4 120863 5), WHO TechnicalReport Series, No. 863, WHO Geneva, 1996 (35 Swiss Francs) ± these guidelines arealso included in Quality Assurance of Pharmaceuticals: A compendium of guidelinesand related materials, Volume 2, Good manufacturing practices and inspection.

The International Pharmacopoeia , Third Edition Volumes 1, 2, 3, 4




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Global a s well a s lo cal

Quali ty Compe ti tion .

CHALLANG ES

Emerging Guideline s.

Re stri cted Marke ts.




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RECOMMENDATIONS

A concerted effort by Manufacturers

and Regulators.

Standardization of Preparations

and Herbs.

Q.C methods for Herbs.

Awareness among growers and

Collectors.




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Documents

cGMP and it’s Importance in Herbal Preparations 2010