The FDAs New cGMP Initiative

In August 2002, the FDA announced a new initiative to cGMP. The initiative is called Pharmaceutical cGMPs for the 21st Century A Risk-Based Approach. It is a 2 year program, and there are three goals to this initiative  

A steering committee was formed and the FDA has been working on this initiative with industry groups. The following are the five principles for guiding the initiative  

The risk-based approach merges science-based policies and standards with an integrated quality system. This is to ensure that the FDA s resources are directed to address those areas that are considered to have higher risks for example, companies with previous compliance problems, new companies with unknown history, and processes requiring aseptic procedures. 

There are three steps to implementing the risk-based approach  

Regulatory authorities such as the FDA have prepared guidelines on comparability protocol, Comparability Protocols—Chemistry, Manufacturing and Controls Information, to enable manufacturers to follow a plan to establish and substantiate that changes to postapproval processes do not affect drug quality. 

Harmonized Tripartite Guideline Q1A Stability Testing of New Drug Substances and Products (November 2000) sets out the guidelines for testing the stabilities of new drug substances. 

The ICH has specified storage conditions to evaluate drug stability as part of the submission data for drug approval (Table 9.6). 

Study Storage condition Minimum period covered by data at submission 

Chapter 9 Good Manufacturing Practice Regulatory Requirements 

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