How GMPs Change

GMPs change when the regulations change, but they also change in other informal and formal ways. In past warning letters, FDA has said,

We acknowledge that the CGMP regulations are not explicit [for example in this particular Warning Letter] about annual stability testing. However, it should be noted that the CGMP regulations are not all inclusive and that what determines a manufacturing practice to be “current” and “good” is if it can be considered feasible and valuable.

Industry practice is one of the things that form the basis of “feasible and valuable” – other firms are doing it (“feasible”) and they are achieving better levels of control of products, processes, and information used to make a decision about a product or process (e.g., laboratory testing data).   This is an example of an informal change – an evolution of improved technology or better practices.

A more formal way of presenting FDA’s expectations to industry is through its guidance documents, which FDA has defined as “current agency thinking”.

Some examples of guidance documents that help interpret or present FDA’s current thinking on CGMP topics include:

• Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (Finalized, 2006) [PDF]

• Investigating Out-of-Specification Test Results for Pharmaceutical Production (Finalized, 2006) [PDF]

• Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (Finalized, 2006) [PDF]

• Part 11, Electronic Records; Electronic Signatures — Scope and Application (Finalized, 2003) [PDF]

• PAT (Process Analytical Technology) — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Finalized, 2004) [PDF]

• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (Finalized, 2004) [PDF]

• Testing of Glycerin for Diethylene Glycol (Finalized 2007) [PDF]