FDA Announces Availability of Final Guidance - Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports The Food and Drug Administration is announcing the availability of a final guidance for industry titled, "Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports." This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA generally considers to have a minimal potential to adversely affect the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. The number of CMC manufacturing supplements for BLAs has increased over the last several years. In keeping with a risk-based approach to CMC review, FDA has evaluated the types of changes that have been submitted in postapproval manufacturing supplements and determined that certain changes being reported generally present minimal risk to the quality of the product. Under FDA regulations, such minor changes in the product, production process, quality controls, equipment, facilities, or responsible personnel must be documented by applicants in an annual report. This guidance applies to biological products that fall under one of the following categories: therapeutic DNA plasmid products, therapeutic synthetic peptide products of 40 or fewer amino acids, monoclonal antibody products for in vivo use, and therapeutic recombinant DNA-derived products. It also applies to combination products licensed under a BLA, where the biological product constituent part falls under one of these categories. The guidance does not apply to blood or blood components, blood-derived products, in vitro diagnostics, cellular and gene therapy products, or vaccines and related products; however, a BLA holder for any other naturally derived biological product should discuss with FDA whether the recommendations in this guidance apply to their BLA. The guidance, which finalizes the draft guidance of the same title dated August 2017, focuses on reporting mechanisms. For information about change management within the pharmaceutical quality system, see International Council for Harmonisation (ICH) guidances for industry Q9 Quality Risk Management (June 2006), Q10 Pharmaceutical Quality System (April 2009), and Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (September 2016). |
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