New FDA Regulation of Pharmaceutical Manufacturing

This initiative aims at ensuring that regulatory review, compliance and inspection policies are based on state-of-the-art pharmaceutical science, and do not impede rapid adoption of new technological advances by the pharmaceutical industry.

Among other things, the agency has issued five new guides designed to enhance the consistency and coordination of its drug quality regulatory programs. These include:

--A guidance for FDA regulated industry on the use of electronic records and signatures.

--A draft guidance on a process for resolving disputes arising over scientific and technical issues related to pharmaceutical current good manufacturing practices (cGMP).

--A draft guidance on the aseptic processes used in the manufacture of sterile drugs, emphasizing current science and risk-based approaches.

--A draft guidance on preparation and use of a comparability protocol for assessing chemistry, manufacturing and control changes to protein drug products and biological products.

A draft guidance for Process Analytical Technology (PAT) - a framework for allowing regulatory processes to more readily adopt state-of-the-art technological advances in drug development, production and quality assurance.

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