cGMP’s GC-A

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GMPs

For PharmaceuticalManufacturing

PART -ADr.Ajmal NasirDirector Technical

BF BiosciencesLahore

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2

GMP

Good Management Practice

Get More ProfitGive More Production

GMP Garrison Military Police

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What is a GMP?

Recognized worldwide for the

control and management of

Manufacturing and testing of

foods, pharmaceuticals,

medical devices

http://en.wikipedia.org/wiki/Current_good_manufacturing_practice

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Good Manufacturing Practices (GMP)could be described as " Conformance

with codes of practice, industrystandards, regulations and laws

concerning production, processing,handling, labeling and sale of foods/drugs decreed by industry, local,

state, national and international bodieswith the intention of protecting the

public from illness, productadulteration and fraud.Codex Alimentarius Committee .

What is a GMP?

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Today GMPs mean a process

must be performed according

to industry standards.

What is a GMP?

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OBJECTIVES

To understand:

Where the regulations comefrom,

Who has enforcement authority,

And why you need to comply

Fundamentals", "Benefits and KeyParts of cGMPs

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WHY WERE GMPs INITIATED

Regulations Dont

HappenOn Their Own

Events Precipitate Them

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Medicine men competed with thecircuses, the minstrel shows, and "wild

west" performers to entertain thepublic and to sell their products .

Hamlin's Wizard Oil was one of the mostpopular and spectacular drugs of the

big touring medicine shows.

This liniment (for minor aches andpains) was sold long after the showshad eased.

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Hamlin's Wizard Oil

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SNAKE OIL?

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1906 book by Upton SinclairThe Jungle

exposed the dangers involved inthe meat packing industryHelped drive public opinion tosupport a new law passed by

Congress

Food Drug and Cosmetic Act Shocking disclosures of

insanitary conditions in meat-packing plants,

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Use ofpoisonous preservatives anddyes,

Cure-all claims for worthless anddangerous patent medicines


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Despite these laws, there was a cavalier attituderegarding drugs and medicines.

Chemical preservatives and toxic colors were virtuallyuncontrolled.

Sanitation was primitive

Ice was principal means of refrigeration

Milk was unpasteurized and cows were not tested fortuberculosis

Pioneers of bacteriology were just starting their stringof victories over infectious diseases


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Thousands of so-called patent medicines

such as Kick-a-poo Indian Sagwa and

Warner's Safe Cure for Diabetes were

available

Medicines containing opium, morphine,

heroin, and cocaine were sold without

restriction and their labels gave no hint of

their presence


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Kick-a-poo Indian Sagwa

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Kick-a-poo Indian Sagwa

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Warner's Safe Cure forDiabetes

THE PERIOD

WAS

GOLDEN AGE

OF

QUACKERY

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Labels did not list ingredients andwarnings against misuse werenonexistent

The information the public receivedcame frequently from bitterexperience.

1906 Spurred by Dr. Wileys efforts,

the Food and Drugs Act was passed onJune 30 Signed by President TheodoreRoosevelt


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WHAT ARE cGMPS?

Current Good Manufacturing PracticesCome from:

The Food Drug and Cosmetic Act

Rules set up by the FDA that drug manufacturers needsto follow in order to ensure that a safe and effectiveproduct is manufactured

WHO

Various drug Regulatory authorities ofDeveloped countries like Japan ,Canada,Germany Australia.

Many countries has adopted various cGMPS .

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TIME LINE OF REGULATIONS

1202

King John of England

Assize of Bread

1820

USP was established

First compendium of standard drugs for US

1848

Drug Importation Act

Requires U.S. Customs Service to stop entry of adulterated drugs from overseas

1862

President Lincoln appoints a chemist, Charles M. Wetherill, to serve in new Department of Agriculture

Beginning of Bureau of Chemistry, the predecessor of the Food and Drug Administration

1898

Association of Official Agricultural Chemists (AOAC International) establishes Committee on FoodStandards headed by Dr. Wiley

1902The Biologics Control Act is passed to ensure purity and safety of serums, vaccines, and similar productsused to prevent or treat diseases in humans

1937Elixir of Sulfanilamide, containing diethylene glycol, kills 107 persons, many of whom are children

1962

Thalidomide found to cause birth defects in thousands of babies born in western Europe Aroused publicsupport for stronger drug regulation

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HISTORY OF GMPs

First GMP regulation in 1962.

First official document in Canada in 1957

Current GMP in 1980s

Originally based upon best industrypractices.

Evolved with improvement of technologyand practices.

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1962 Drug Amendments

Congress instructed FDA to require that all

drugs be produced according to

Good Manufacturing Practices (GMP)

The word current was later added to make it cGMP

to imply that the regulation allows for changing

technology in attaining GMPs

HOW WERE GMPs INITIATED

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1978

cGMPs were rewritten to deal with

personnel and facilities, processes andproducts

1973US Supreme Court upholds 1962 drug

effectiveness law and endorses FDA tocontrol products by Regulationsrather than Litigation


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1978 cGMPs were rewritten to deal with

personnel and facilities, processes andproducts

1988

FDA officially established as an agency ofthe Department of Health and Human

Services

Commissioner officially appointed by thePresident


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1997

FDA Modernization Act

Required consistent and efficientregulatory requirements


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GMPs continue to evolve,

partially due to mistakes

and partially based on

companies wanting

more guidance.

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THE LESSON?

Do the right thing


cGMP’s GC-A

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