AccuReg: GMP Basics

The Regulatory Clinic: December 1995
GMP Basics

Q: I am a new employee in the laboratory of a small pharmaceutical firm and this is my first job out of college. Everyone here talks about GMP, but I don't really know what it is. All I know is that it has to do with FDA regulations that we are supposed to follow. I'm afraid to ask anyone about this. Can you explain GMP for me? "Green But Willing," Philadelphia, PA

Dear "Green":

Please be assured that your plight is not uncommon. You are correct that GMPs (usually referred to as cGMPs, which stands for current Good Manufacturing Practices) are mandated by FDA. Medical product companies (companies producing drugs and medical devices) that do not adhere to GMPs are subject to legal action under the auspices of the Federal Food, Drug, and Cosmetic Act. The Act and related regulations, such as the GMPs, were developed over time as the government responded to various public health crises caused by unsafe or ineffective medical products. FDA's charge, and the purpose of GMPs, is to ensure that medical products are safe and have the "identity and strength and meet the quality and purity characteristics" that they are purported or represented to possess.

The GMPs are a quality assurance system that requires control of the drug (or device) production process from the time materials (excipients, actives, and packaging and labeling materials) are received at the plant, through production and testing, and into the commercial marketplace. Support systems such as employee training, quality assurance review and release of product, etc., are also required. The requirements of the GMPs are published in the Federal Register, but these are general and represent the minimum requirements around which a company should construct its own very specific quality program. FDA has certain expectations as to what must be covered and how matters must be handled to meet the requirements of GMP, depending on the type of product manufactured and the current state of the art in a particular industry. FDA expects manufacturers to remain current in the state of the art of manufacture, testing, and packaging of their products, usually referred to as cGMP. Interpreting the generalities and remaining current is where the GMPs can get tricky, and training and experience are needed to be able to consistently meet FDA's expectations.

The GMPs require thorough documentation. In FDA's eyes, if it is not documented, it did not happen or does not exist. Every procedure must be committed to writing and reflect the actual operating practices at the company. All critical steps in the process must be controlled and recorded in a detailed manner. Critical processes -- including manufacturing, cleaning, and test methodologies -- must be validated with documented evidence that they consistently perform their intended function such that the result of the process meets pre-determined quality attributes.

FDA conducts routine and special inspections of medical product manufacturers to determine if the company is operating in a state of compliance with cGMP requirements. The consequences of a finding that products are not manufactured to GMP range from a listing of observations on an FDA form 483 and a possible warning letter, to injunction and seizure, to criminal indictment if repeated warnings are not heeded. But legal ramifications aside, it is just good, common sense to employ a comprehensive quality system for the manufacture of any product, and the one mandated for medical products is the GMPs.

Finally, your letter raises the GMP issue of training. It is required that all employees working in a GMP-controlled area receive formal, documented training, and you should ask your supervisor to include you in the corporate training program as soon as possible.

By Nancy L. Carroll, AccuReg Associate

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