In April, the FDA released a Guidance Document, entitled, “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs) – Questions and Answers – Guidance for Industry.” The document is intended to “provide guidance regarding good manufacturing practice (GMP) for the manufacturing of APIs under an appropriate system for managing quality…and help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.”
The Guidance reads that although the manufacturer’s quality unit is responsible for establishing a system to release or reject raw materials, intermediates, packaging, and labeling materials, testing does not need to be performed by the quality unit and can be performed at a qualified third-party laboratory. Testing frequency for validating of supplier materials and finished products as well as environmental monitoring and residue analysis is left up to the quality unit. A risk-based approach is recommended for determining testing specifications and frequency.
Regarding identity testing of materials, the document states,” (f)or incoming production materials, identity tests and related methods should be used as described in the relevant sections of a pharmacopoeia monograph, in an approved regulatory filing, or in an in-house specification (including method/analytical procedure). When available, a discriminating test should be considered for identification testing. The visual examination of a label or the material is not considered sufficient.”
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