What is Current Good Manufacturing Practices Compliance (cGMP)?

In the United States, Current Good Manufacturing Practices (cGMP) are the Food
and Drug Administration’s (FDA) formal regulations regarding the design,
monitoring, control, and maintenance of manufacturing processes and facilities. The
word “current” was added to signal to companies that they needed to remain up to
date with the latest technologies, not rely on what was a good practice ten years
ago.

cGMPs are followed by pharmaceutical and biotechnology companies to ensure that

their items are manufactured to specific requirements including identity, strength,
quality, and purity. Good Manufacturing Practices are regulated by the Food and
Drug Administration (FDA).

There are a number of federal regulations that relate to cGMP which, if not
followed, can lead to criminal penalties. There are two specific regulations that
relate to pharmaceutical manufacturers, one for biological products, and a
regulation that regulates electronic records and electronic signatures.

It is important to note that CGMPs are minimum requirements. Many

pharmaceutical manufacturers are already implementing comprehensive, modern
quality systems and risk management approaches that exceed these minimum
standards.

Importance of cGMP

A consumer usually cannot detect (through smell, touch, or sight) that a drug
product is safe or if it will work. While CGMPs require testing, testing alone is not
adequate to ensure quality. In most instances, testing is done on a small sample of
a batch (for example, a drug manufacturer may test 100 tablets from a batch that
contains 2 million tablets), so that most of the batch can be used for patients rather
than destroyed by testing. Therefore, it is important that drugs are manufactured
under conditions and practices required by the cGMP regulations to assure that
quality is built into the design and manufacturing process at every step. Facilities
that are in good condition, equipment that is properly maintained and calibrated,
employees who are qualified and fully trained, and processes that are reliable and
reproducible, are a few examples of how cGMP requirements help to assure the
safety and efficacy of drug products.

If the failure to meet CGMPs results in the distribution of a drug that does not offer
the benefit as labeled because, for example, it has too little active ingredient, the
company may subsequently recall that product. This protects the public from
further harm by removing these drugs from the market. While FDA cannot force a
company to recall a drug, companies usually will recall voluntarily or at FDA’s
request. If a company refuses to recall a drug, FDA can warn the public and can
seize the drug.

Code of Federal Regulations (CFR)

The Code of Federal Regulations (CFR) is a codification of the general and

permanent rules of the federal government. The CFR contains the complete and
official text of the regulations that are enforced by federal agencies.

The CFR is divided into 50 titles that represent broad areas subject to Federal
regulations. Each title is divided into chapters that are assigned to various agencies
issuing regulations pertaining to that broad subject area. Each chapter is divided
into parts covering specific regulatory areas. Each part or subpart is then divided
into sections — the basic unit of the CFR.

cGMP and the Pharmaceutical Industry

The CFR’s that relate to cGMP in the pharmaceutical and biotechnology companies
are:

21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing,

Processing, Packing, or Holding of Drugs; General Part (includes the definitions that
are used in the regulations such as batch, lot, etc.).

21 CFR Part 211 – Current Good Manufacturing Practice for Finished

Pharmaceuticals

21 CFR Part 600 – Biological Products: General (contains key definitions,

establishment standards, establishment inspection requirements and adverse
experience reporting requirements).

21 CFR Part 11 – Electronic Records; Electronic Signatures (defines the criteria

under which electronic records and electronic signatures are considered to be
trustworthy, reliable and equivalent to paper records. Part 11 also applies to
submissions made to the FDA in electronic format.)

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