What Is CGMP Manufacturing?

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cGMP is an acronym of "current Good Manufacturing Practices." cGMP is a form of standardized protocol used in the manufacture of pharmaceuticals, food and medical devices. cGMP was designed to ensure that processes performed, equipment used, in-process testing and end process testing comply within the standards through proper traceable documentation.

Agency that Enforces and Ensures cGMP Protocol

The FDA enforces cGMP in the United States.

The Food and Drug Administration are the primary overseers of cGMP in the United States. Over 100 countries have mandatory compliance rules regarding good manufacturing processes.

How cGMP Is Enforced

Bread Palletizing--Machines to twist ties must be documented.

Random and scheduled audits are done from time to time by the governing authority to ensure that companies are complying with cGMP. Many companies use private auditors or hire full-time individuals or groups to oversee the process internally to ensure governing audits will be passed.

Some Rules of cGMP

Every function of the manufacturing process is guided by cGMP. Equipment used must be tested and calibrated on a regular schedule, sterile environments must be regulated and raw materials must meet cGMP standards. Lot traceability of every component is also necessary.

Employee Training in cGMP is Required

Employees must be trained and certified in cGMP practices and documentation including: janitorial, clean room setup, contamination avoidance, testing, random sampling, labeling, bottling, packaging and instructions.

Failure to Meet cGMP Standards

Miscarriages of procedure must be thoroughly documented, traced to the exact cause, and corrected or aborted. Product recalls should never happen if cGMP manufacturing is followed, but even the tiniest mistake must be documented and/or reported to the governing authority in its precinct.