Description
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.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2Specific container sampling requirements for batches
Subject to mandatory recall provisions
Stakeholders
3Responsible for declaring acceptable market names on labels.
Assist sponsors in the nonclinical evaluation
Evaluates selected pharmacopoeial texts for recognition
Regulatory Context
Regulatory Activities
3Submissions supported by clinical trial data.
Regulatory mechanisms for method changes
Handling compendial changes
Document Types
1The PDG Stage 5B sign-off document: Japanese Pharmacopoeial Forum
Technical Details
Substances
1Should not have antibacterial or antifungal properties
Testing Methods
1Test performed at release
Standards & References
External Standards
6Japanese Pharmacopoeia Sterility Test
Sterility testing may be performed in accordance with USP <71>.
European Pharmacopoeia Sterility monograph
United States Pharmacopeia sterility test text
Japanese Pharmacopoeia sterility test text
European Pharmacopoeia sterility test text
Specifications
1limits for solid state form and particle size; Tightening acceptance criteria; Numerical limits or ranges for tests
ICH References (2)
Sterility Test General Chapter evaluation for interchangeability
Evaluation and Recommendation of Pharmacopoeial Texts
See Also (8)
- Advanced Manufacturing Technologies Designation Program
- Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers
- Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry
- Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products: Guidance for Industry
- Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry: Guidance for Industry
- CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports
- Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry: Guidance for Industry
- Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry: Draft Guidance for Industry