FDA – Sterile Drug Products Produced by Aseptic Processing — cGMP

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This guidance document discusses selected issues and does not address all aspects of aseptic processing. For example, the guidance addresses primarily finished drug product CGMP issues
while only limited information is provided regarding upstream bulk processing steps. This guidance updates the 1987 Aseptic Processing Guideline primarily with respect to personnel qualification, cleanroom design, process design, quality control, environmental monitoring, and review of production records. The use of isolators for aseptic processing is also discussed.

Although this guidance document discusses CGMP issues relating to the sterilization of components, containers, and closures, terminal sterilization of drug products is not addressed. It is a well-accepted principle that sterile drugs should be manufactured using aseptic processing only when terminal sterilization is not feasible. However, some final packaging may afford some unique and substantial advantage (e.g., some dual-chamber syringes) that would not be possible if terminal sterilization were employed. In such cases, a manufacturer can explore the option of adding adjunct processing steps to increase the level of sterility assurance.

A list of references that may be of value to the reader is included at the conclusion of this
document.

 

Download PDF here

Continue at: https://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf

 

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