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Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions
Annex 4B: Microbiological Examination of
Non-Sterile Products: Tests for Specified
Micro-organisms General Chapter
(PDF version of this document)
| This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic.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. |
For questions regarding this draft document contact (CDER) Robert King 301-796-1242, or (CBER) Christopher Joneckis 301-827-0373.
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
Draft Consensus Guideline
Q4B - Annex 4B
Evaluation and Recommendation of Pharmacopoeial Texts
for Use in the ICH Regions
ON
Microbiological Examination of Non-Sterile Products:
Tests for Specified Micro-organisms
General Chapter
Current Step 2 Version
Dated June 5, 2008
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.
Q4B -- Annex 4B
Evaluation and Recommendation of Pharmacopoeial Texts
for Use in the ICH Regions
ON
Microbiological Examination of Non-Sterile Products:
Tests for Specified Micro-organisms
General Chapter
ICH Consensus Guideline
Released for Consultation on June 5, 2008, at Step 2 of the ICH Process
1. Introduction
This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
2. Q4B Outcome
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. 2.6.13. Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms, JP 4.05 Microbiological Examination of Non-Sterile Products: II. Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms, and USP <62> Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms can be used as interchangeable in the ICH regions.
2.2 Acceptance Criteria
The proposed texts evaluated did not contain acceptance criteria.
3. Timing of Annex Implementation
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 might differ for each region.
4. Considerations for Implementation
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 with reference to 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, in accordance with the conditions set out in this annex, as fulfilling the requirements for compliance with the Ph. Eur. Chapter 2.6.13. on the basis of the declaration of interchangeability made above.
4.4 MHLW consideration: The pharmacopoeial texts referenced in Section 2 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. References Used for the Q4B Evaluation
5.1 The PDG Stage 5B sign-off document: Japanese Pharmacopoeial Forum, Volume 14, Number 4, (December 2005)
5.2 The pharmacopoeial references for Microbiological Examination of Non-Sterile Products:
Tests for Specified Micro-organisms for this annex are:
5.2.1 European Pharmacopoeia (Ph. Eur.):
6.3 Edition (official on January 2009) Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms (reference 01/2009: 20613)
5.2.2 Japanese Pharmacopoeia (JP):
4.05 Microbiological Examination of Non-Sterile Products: II. Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms as it appears in Supplement I to the Japanese Pharmacopoeia Fifteenth Edition, (September 28, 2007, The Ministry of Health, Labour and Welfare Ministerial Notification No. 316). The English version was published on January 9, 2008.
5.2.3 United States Pharmacopeia (USP):
<62> Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms official in USP 30, January 2007.
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Date created: August 22, 2008 |
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