FDA GMP

The FDA GMP stands for “good manufacturing practice.” The GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that should be observed during manufacturing. The GMP is part of the FDA approval process.

GMP is part of a quality system covering the manufacture and testing of:

• Active pharmaceutical ingredients
• Diagnostics
• Foods
• Pharmaceutical products
• Medical devices

The FDA GMP guidelines outline those aspects of production and testing that can impact the quality of a product. There are many guidelines and I describe some of them here.

• Manufacturing processes should be clearly defined and controlled. The processes need validation to ensure consistency and compliance with specifications.
• Any changes to the manufacturing process need evaluation and validation, if necessary.
• Instructions and procedures are written in clear and unambiguous language.
• Operators need training to carry out and document the procedures and processes.
• Records made during manufacture demonstrate that all the steps required by the defined instructions were in fact taken. The quantity and quality of the drug was as expected. Deviations require investigation and documentation.
• Records of manufacture should enable the complete history of a batch of products be retained in a comprehensive and accessible form.
• Distribution should minimize risk to their quality.
• A system should be available to recall any batch of drug from sale or supply.
• Complaints about marketed drugs receive examination, the causes of the quality defects, if any, require investigation, and appropriate measures need attention with respect to the defective drugs.

When a company is setting up its quality program and manufacturing processes, there are many ways to fulfill GMP requirements. It is incumbent on the company to determine the most effective and efficient quality processes.

The US FDA enforces the GMPs based on the Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938. The FDA regulations use the phrase “current good manufacturing practice” (cGMP) that describe the guidelines. As of June 2010, the cGMP requirements apply to all manufacturers of dietary supplements. A dietary supplement is a food supplement, such as vitamins.

The World Health Organization (WHO) has a version of GMP that pharmaceutical regulators use in over one hundred countries worldwide. The European Union’s GMP enforces similar requirements to WHO GMP as does the FDA version in the US.

There are other good-practice systems similar to the GMP system.

• Good laboratory practice (GLP) for laboratories conducting non-clinical studies, e.g. toxicology and pharmacology studies in animals.
• Good clinical practice (GCP) for hospitals and clinicians conducting clinical trials on new drugs in humans.
• Good regulatory practice (GRP) for the management of regulatory commitments, procedures, and documentation.

There is a “good automated manufacturing practice” (GAMP) that is a trademark of the International Society for Pharmaceutical Engineering. It is a set of principles and procedures that help ensure that pharmaceutical products have the required quality. GAMP covers all aspects of production including the raw material, the facility and the training of the staff.

The FDA GMP is the gold standard for the manufacture of drugs, and now, dietary supplements. These guidelines exist in all manufacturing countries of the world.

Written by: Margaret Stenerson

10 5 2010