Tag: Laboratory controls Sterile Pharmaceutical Drug Products

Guidance for Sterile Pharmaceutical Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. X. LABORATORY CONTROLS 21 CFR 211.22(b) states that “Adequate laboratory facilities for the testing and approval (or rejection) of components, pharmaceutical drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.”…