FDA Good Manufacturing Practice Guidance for APIs

FDA released a guidance “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients ” on 9/24/01.Although directed towards API manufactuers the validation sections provide explanations that seem relevant to Drug and Device Manufacturers in general.

This guidance is consistent with the ICH’s version posted separately.

Section V.D of this guideline is a specific section with some basic requirements for computerized system.

Section XII of the guideline is on Validation in general. Qualification of equipment is discussed including Design Qualification(DQ), Installation Qualification(IQ), Operational Qualification(IQ), and Process Qualification(PQ). In addition conditions under which prospective, concurrent, and retrospective valdation approaches can be used is explained. .
Section 12.6 discusses revalidation and states conditions under which periodic revalidation is not necessary.

Although this guidleline is for APIs it is likely the concepts are valid for qualification and validation represent current thinking in other applications as well.

The full guideline is at the link provided.

SoftwareCPR keywords: Drug, OTSS, process validation

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

Corporate Office

Partners located in the US (CA, FL, MA, MN, TN) and Italy.