USA – Q4B Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use

This annex is one in a series of guidance documents that describe the evaluations and
recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.

This annex is the result of the Q4B process for Microbiological Examination of Nonsterile
Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for
Pharmaceutical Use. The proposed texts were submitted by the Pharmacopoeial Discussion
Group (PDG). For each regulatory region, the pharmacopoeial text is nonmandatory and is
provided for informational purposes only. This revision, Q4B Annex 4C(R1), adds the Health
Canada interchangeability statement in section IV.E (4.5).

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required…