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US FDA clarifies what constitutes 'minor' change to biologic production process

By Gareth MacDonald+



The US FDA has sought to clarify when biologics firms should inform it about minor changes to manufacturing processes in draft guidance this week.

The US Food and Drug Administration (FDA) draft guidance  sets out what changes to manufacturing processes and facilities, production equipment and storage systems it considers to be “minor.”

The FDA said: “The number of CMC manufacturing supplements for BLAs has continued to increase over the last several years.

In connection with FDA’s Pharmaceutical Product Quality Initiative and our risk-based approach to CMC review, we have 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 current FDA guidelines biologics license application holders are required to assess the impact of and report all postapproval changes. However, the way they must report them varies based on the scale of the change.

Drug firms that plan to make “major” changes to production processes must seek FDA approval before shipping any products made through the new process.

Moderate changes – those deemed to have moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug – must be logged with the agency 30 days before product is distributed.

Minor changes to production processes, in contrast, need only be recorded in an annual report submitted to the FDA.

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