Sterile drug products produced by Aseptic processing — Current good manufacturing practice

This white paper by the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is intended to help manufacturers meet the requirements in the agency's current good manufacturing practice (cGMP) regulations (2l CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing. It describes the types of information and data that should be included in drug applications to demonstrate the efficacy of a manufacturer's sterilization process, and complements the submission guidance by describing procedures and practices that will help enable a sterile drug manufacturing facility to meet cGMP requirements relating, for example, to facility design, equipment suitability, process validation and quality.

The guidance addresses primarily finished drug product cGMP issues and 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.

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