Direct Links to important GMP Sterile & Aseptic Processing Guidelines

This guidance relates to the time between the product and time of administration ot the patient

Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.

These guidelines relate to all microbiology laboratories involved in sterility Testing; detection, isolation, enumeration and identification of microorganisms and assay activities, whether they are independent or a department or unit of a pharmaceutical manufacturing facility.

This guideline provides guidance on the documentation expected for sterile products in the quality dossier for a marketing authorisation application or a variation application for a medicinal product, (called quality dossier throughout the guideline), and the selection of appropriate methods of sterilisation for sterile products. Although, terminal sterilisation using a reference condition of the European Pharmacopoeia (Ph. Eur) is the method of choice whenever possible, this guideline provides information on when other terminal sterilisation processes, sterilising filtration or aseptic processing, (either alone or when combined with an additional terminal microbial reduction process), could be accepted as an alternative to a reference terminal sterilisation process.