In 2002, FDA launched an initiative entitled, “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach” to encourage the implementation of a modern, risk-based pharmaceutical quality assessment system.
In an effort to support that initiative, FDA released a draft guidance document titled “Request for Quality Metrics: Guidance for Industry” in July of 2015. This draft guidance document includes the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research’s (CBER) proposal on the data and quality metrics they intend to collect to support continuous improvement in the pharmaceutical manufacturing industry.
This guidance document applies to drug manufacturers, but does not apply to those organizations not required to register under Section 510 of the FD&C Act. FDA has extended the comment period for this guidance document to November 27, 2015. Therefore, it is critical for pharmaceutical manufacturers to understand the quality metrics described in the guidance document and report comments and concerns to FDA through www.regulations.gov.
Who does the draft guidance document apply to?
The document applies to establishments that are engaged in the manufacture, preparation, propagation, compounding, or processing of finished dosage forms (FDFs) of covered drug products or active pharmaceutical ingredients (API) used in the manufacture of covered drug products.
With respect to the guidance document, a covered drug product includes: a product that is subject to an approved application under section 505 of the FD&C Act or under section 351 of the PHS Act; products that are marketed pursuant to an OTC monograph; and products that are marketed unapproved drug product.
Who is exempt from the requirements in the guidance document?
The draft guidance document on quality metrics for pharmaceutical manufacturers includes a list of establishments that are not required to comply with the contents of the guidance document. This includes the following organizations:
• Establishments that are not required to register under Section 510 of the FD&C Act and regulations FDA has issued at 21 CFR 207.10
• Compounders operating under section 503A or registered as outsourcing facilities under section 503B of the FD&C Act
• Medical gas manufacturers
• Positron emissions tomography manufacturers
• Manufacturers of blood and blood components for transfusion, vaccines, cell therapy products, gene therapy products, allergenic extracts, human cells, tissues, cellular and tissue-based products and non-recombinant versions of plasma-derived products
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