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FDA draft CMC guidance could cut down on red tape

Published on 30/06/10 at 10:51am

The FDA has published draft guidance aimed at alleviating the burden on pharmaceutical companies of notifying the agency of minor changes to their manufacturing processes.

The Post-approval Manufacturing Changes Reportable in Annual Reports document (which can be downloaded here) focuses on chemistry, manufacturing and controls (CMC) changes that the US regulator considers to have minimal potential to have an adverse effect on product quality.

So, rather than requiring individual notification to the agency, the guidance proposes to allow companies to bundle these changes into a single, annual report which will cut down the workload for companies and the regulatory authority.

Around 40 CMC changes are listed in the guidance, broadly broken down into six categories as follows:

Components and composition: An example is the use of a new supplier of inactive ingredients with a minimal effect on product performance;

Manufacturing sites: For example, making an additional product in an already-approved multiple-product manufacturing area

Manufacturing process: For instance, replacing a piece of equipment with another of the same design and operating principle

Specifications: One example given is a change in the approved analytical procedure, provided the revised method provides equivalent or increased assurance of quality

Container/closure system: It should be possible to use a contract manufacturing organisation to wash a drug product stopper, provided the license holder certifies the washing process is validated

Miscellaneous: This category could include extending a product's expiry based on real-time stability data from pilot scale batches following an approved stability protocol

The document stresses that the list is a guide only - license holders must still evaluate changes to determine whether they could have an impact on the "identity, strength, quality, purity or potency" of a drug product.

The move comes after an increase in the number of CMC changes to New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) being submitted to the FDA in recent years, which has encouraged the agency to adopt a risk-based approach to overseeing them.

Comments on the draft guidance should be submitted by September 23.

Phil Taylor

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