Draft Guidance on current good manufacturing practice for Medical gases


The US FDA has issued a draft guidance on Current Good Manufacturing Practice (CGMP) for medical gases. The regulatory authority expects the industry to respond before August end. This guidance is intended to assist manufacturers of medical gases in complying with applicable CGMP regulations (21 CFR parts 210 and 211).Medical gases are generally regulated as finished pharmaceuticals and are subject to CGMP requirements regardless of the processing stage. Compliance with applicable new norms helps to ensure the safety, identity, strength, quality, and purity of medical gases. This is because medical gases that are not manufactured, processed, packed, or held according to applicable CGMP requirements can cause serious injury or fatality.This guidance applies to medical gases that meet the definition of a drug under section 201(g)(1) of the FD&C Act, including those that are recognized in the United States Pharmacopeia-National Formulary (USP-NF). Gases for industrial applications or non-drug medical applications are not part of the guidance. Medical gases are generally considered finished drug products.The establishment of an effective quality system reflects the principle that quality should be built into the product; testing alone cannot ensure product quality. 21 CFR 211.22 provides that the quality control unit has the authority needed to create, monitor, and implement a quality system. The quality unit's responsibilities and procedures must be in writing and its procedures must be followed. https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm070270.pdf
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