ICH Draft Guidance
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter
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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
Draft Consensus Guideline
Q4B - Annex 3
Evaluation and Recommendation of Pharmacopoeial Texts
for Use in the ICH Regions ON Test for Particulate Contamination: Sub-Visible Particles
Current Step 2 Version
Dated November 1, 2007
At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Steering Committee to the regulatory authorities of the three ICH regions (the European Union, Japan and the USA) for internal and external consultation, according to national or regional procedures.
Released for Consultation on November 1, 2007, at Step 2 of the ICH Process
| This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. |
- Introduction
- Q4B Outcome
- Timing of Annex Implementation
- Considerations for Implementation
- References used for the Q4B Evaluation
This annex is the result of the Q4B process for Test for Particulate Contamination: Sub-Visible Particles. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
2.1. Analytical Procedures
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the official pharmacopoeial texts, Ph.Eur. 20919 Particulate Contamination: Sub-visible Particles, JP 6.07 Insoluble Particulate Matter Test for Injections, and USP <788> Particulate Matter in Injections General Chapter can be used as interchangeable in the ICH regions given the following:2.1.1 Instrument calibration and system suitability measurements should follow regional GMP requirements.
2.2. Acceptance Criteria
Except for nominal 100-milliliter (mL) parenteral products, the acceptance criteria are interchangeable. At the 100-mL nominal volume, the criteria specified in JP are more stringent than those in the other two pharmacopoeias; therefore, the criteria are not interchangeable at that volume.
When this annex is implemented (incorporated into the regulatory process at ICH Step 5) in a region, it can be used in that region. Timing may differ for each region.
4.1 General consideration: When sponsors or manufacturers change their existing methods to the implemented Q4B-evaluated pharmacopoeial texts that are referenced in Section 2.1 of this annex, any change notification, variation, and/or prior approval procedures should be handled in accordance with established regional regulatory mechanisms pertaining to compendial changes.
4.2 FDA consideration: Based on the recommendation above, and in accordance with the conditions set forth in this annex, the pharmacopoeial texts referenced in Section 2.1 of this annex can be considered interchangeable. However, FDA might request that a company demonstrate that the chosen method is acceptable and suitable for a specific material or product, irrespective of the origin of the method.
4.3 EU consideration: For the European Union, the monographs of the Ph. Eur. have mandatory applicability. Regulatory authorities can accept the reference in a marketing authorisation application, renewal or variation application citing the use of the corresponding text from another pharmacopoeia as referenced in Section 2.1, in accordance with the conditions set out in this annex, as fulfilling the requirements for compliance with the Ph. Eur. Chapter, Particulate Contamination: Sub-visible Particles: 20919, on the basis of the declaration of interchangeability made above.
4.4 MHLW consideration: The pharmacopoeial texts referenced in Section 2.1 of this annex can be used as interchangeable in accordance with the conditions set out in this annex. Details of implementation requirements will be provided in the notification by MHLW when this annex is implemented.
5.1 The PDG Stage 5B sign-off document: Japanese Pharmacopoeial Forum, Volume 13, Number 3 (August 2004)
5.2 The pharmacopoeial references for Particulate Matter for this annex are::
5.2.1 European Pharmacopoeia (Ph. Eur.): 5th Edition (official on January 2005) Particulate Contamination: Sub-visible Particles (reference 01/2005: 20919)
5.2.2 Japanese Pharmacopoeia (JP): 6.07 Insoluble Particulate Matter Test for Injections as it appears in the JP Fifteenth Edition (March 31, 2006, The Ministry of Health, Labour and Welfare Ministerial Notification No. 285). The method was changed in September 2007 to correct a sentence in the introduction as underlined in the text that is appended.
5.2.3 5.2.3 United States Pharmacopeia (USP): <788> Particulate Matter in Injections, Revision Bulletin, April 4, 2007
