Tag Archives: Q4B

FDA Publishes Guidance on Q4B, Dissolution and Test General Chapter Annex 7(R2)

Posted on August 2, 2011 by admin| Leave a comment

FDA Publishes Guidance on Q4B, Dissolution and Test General Chapter Annex 7(R2)

Full Text Here

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.



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EMA Publish ICH Q4B Annex 7(R2) Gudiance on Dissolution Tests

Posted on January 25, 2011 by admin| Leave a comment

EMA Publish ICH Q4B Annex 7(R2) Guidance on Dissolution Tests.

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This annex is the result of the Q4B process for Dissolution Test.

The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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FDA Publish Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in ICH regions, Annex 11, Capillary Electrophoresis General Chapter

Posted on September 22, 2010 by admin| Leave a comment

FDA Publish Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in ICH regions, Annex 11, Capillary Electrophoresis General Chapter.

Full Text Here

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 the Capillary Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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FDA, the USA Drug Regulator, Published Q4B Evaluation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 14: Bacterial Endotoxins Text General Chapter

Posted on July 27, 2010 by admin| Leave a comment

FDA, the USA Drug Regulator, Published Q4B Evaluation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 14: Bacterial Endotoxins Text General Chapter.

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This annex is the result of the Q4B process for the Bacterial Endotoxins Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.6.14. Bacterial Endotoxins, JP 4.01 Bacterial Endotoxins Test, and USP General Chapter <85> Bacterial Endotoxins Test, can be used as interchangeable in the ICH regions subject to the following conditions:

Any of the three techniques can be used for the test. In the event of doubt or dispute, the gel-clot limit test should be used to make the final decision on compliance for the product being tested.

The Endotoxin Reference Standard should be calibrated to the current WHO (World Health Organization) International Standard for Endotoxin.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators, FDA, Publish Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 6: Uniformity of Dosage Unites General Chapter

Posted on May 26, 2010 by admin| Leave a comment

Drug Regulators, FDA, Publish Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 6: Uniformity of Dosage Unites General Chapter

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This annex is the result of the Q4B process for Uniformity of Dosage Units. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

Q4B OUTCOME
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. 2.9.40. Uniformity of Dosage Units, JP 6.02 Uniformity of Dosage Units, and USP General Chapter <905> Uniformity of Dosage Units, can be used as interchangeable in the ICH regions subject to the following conditions:

The Uniformity of Dosage Unit test is not considered to be interchangeable in the three regions unless the target test sample amount at time of manufacture (T) is 100% (i.e., T=100%).

Unless the 25 milligrams (mg)/25% threshold limit is met, the use of theMass/Weight Variation test as an alternative test for Content Uniformity is not considered interchangeable in all ICH regions.

For specific dosage forms which have been indicated in local text in the pharmacopoeias by enclosing the text within the black diamond symbols, application of the Uniformity of Dosage Units test is not considered interchangeable in all ICH regions.

For Mass/Weight Variation, the PDG-harmonised definition for ‘W Bar’ should be used.

If a correction factor is called for when different procedures are used for assay of the preparation and for the Content Uniformity Test, the correction factor should be specified and justified in the application dossier.

Acceptance Criteria
The acceptance criteria are harmonized between the three pharmacopoeias.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, Publish Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 6: Uniformity of Dosage Unites General Chapter

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Drug Regulators, FDA CDER, Publish Guidance on ICH Q4B Annex 10 Polyacrylamide Gel Electrophoresis General Chapter for Pharmacopoeial Texts

Posted on May 6, 2010 by admin| Leave a comment

Drug Regulators, FDA CDER, Publish Guidance on ICH Q4B Annex 10 Polyacrylamide Gel Electrophoresis General Chapter for Pharmacopoeial Texts

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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 the Polyacrylamide Gel Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulators, FDA, CDER, Publish Guidance on ICH Q4B Annex 7 Dissolution Tests General Chapter for Pharmacopoeial Texts

Posted on May 5, 2010 by admin| Leave a comment

Drug Regulators, FDA, CDER, Publish Guidance on ICH Q4B Annex 7 Dissolution Tests General Chapter for Pharmacopoeial Texts

full text here

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 the Dissolution Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, CDER, Publish Guidance on ICH Q4B Annex 7 Dissolution Tests General Chapter for Pharmacopoeial Texts

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulators, FDA, CDER, Publish Guidance on ICH Tablet Friability Q4B Annex 9

Posted on May 4, 2010 by admin| Leave a comment

Drug Regulators, FDA, CDER, Publish Guidance on ICH Tablet Friability Q4B Annex 9

Full Text Hear

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 the Tablet Friability General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, CDER, Publish Guidance on ICH Tablet Friability Q4B Annex 9

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Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex 8 Sterility Test General Chapter for ICH Regions

Posted on January 8, 2010 by admin| Leave a comment

Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex 8 Sterility Test General Chapter for ICH Regions

Full Text Here

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 the Sterility Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex 8 Sterility Test General Chapter for ICH Regions

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Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex5 Disintegration Test General Chapter for ICH regions

Posted on January 7, 2010 by admin| Leave a comment

Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex5 Disintegration Test General Chapter for ICH regions

Full Text Here

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 Disintegration Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex5 Disintegration Test General Chapter for ICH regions

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Drug Regulators, FDA, Publish Q4B Evaluation and Recommendations for Pharmacopeial Texts for use in ICH regions, Annex 12: Analytical Sieving General Chapter

Posted on December 24, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Q4B Evaluation and Recommendations for Pharmacopeial Texts for use in ICH regions, Annex 12: Analytical Sieving General Chapter

Full Text Here

This annex is the result of the Q4B process for the Analytical Sieving General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.9.38. Particle-size Distribution Estimation by Analytical Sieving, JP 3.04 Particle Size Determination entitled Method 2. Analytical Sieving Method, and USP General Chapter Particle Size Distribution Estimation by 107 Analytical Sieving, can be used as interchangeable in the ICH regions.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194501.pdf

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, Publish Q4B Evaluation and Recommendations for Pharmacopeial Texts for use in ICH regions, Annex 12: Analytical Sieving General Chapter

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Drug Regulators, FDA, Publish Q4B Evaluation and Recomendations for Pharmacopeial Texts for use in ICH regions, Annex 11: Capillary Electrophoresis General Chapter

Posted on December 23, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Q4B Evaluation and Recomendations for Pharmacopoeial Texts for use in ICH regions, Annex 11: Capillary Electrophoresis General Chapter

Full Text on Request

This annex is the result of the Q4B process for the Capillary Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the analytical procedures described in the official
pharmacopoeial texts, Ph.Eur. 2.2.47. Capillary Electrophoresis, JP General Information 4. Capillary Electrophoresis, and USP General Information Chapter <1053> Biotechnology-derived Articles – Capillary Electrophoresis,1 can be used as interchangeable in the ICH regions.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, Publish Q4B Evaluation and Recomendations for Pharmacopeial Texts for use in ICH regions, Annex 11: Capillary Electrophoresis General Chapter

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ICH – Press Release

Posted on December 3, 2009 by admin| Leave a comment

ICH – Press Release

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The International Conference on Harmonisation (ICH) Steering Committee and its expert working groups met in St. Louis, Missouri from October 24-29, 2009. The main achievements are outlined below.

This meeting was highlighted by progress made in the area of safety of pharmaceutical products. The S9 Guideline, “Non-clinical Evaluation of Anticancer Pharmaceuticals”
reached Step 4. This Guideline addresses non-clinical data requirements for pharmaceutical products intended to treat cancer in patients with late stage or advanced disease. The guideline aims to accelerate development and availability of drugs for these patients with unmet medical need while safeguarding patients’ safety. In addition, the S6 Guideline, “Revision of Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals” reached Step 2. This Guideline outlines a reduced duration and number of studies involving animals and could have a major impact on the use of animals in safety testing of pharmaceutical products. ICH remains committed to the “3 R’s” agenda, which is reducing/refining/replacing animal testing in the drafting of new or revision of existing guidelines.

In addition, ICH Safety experts participated in a one day “Safety Brainstorming Session” to discuss any current gaps in ICH safety guidelines and identified several potential  new topics.

There was major progress in the harmonization of pharmacopoeial texts in the three regions which will reduce testing requirements in the three regions. Three Annexes to the Q4B Guideline (Annex 7: Dissolution, Annex 9: Tablet Friability, and Annex 10: Polyacrylamide Gel Electrophoresis) reached Step 4 and another two (Annex 11: Capillary Electrophoresis and Annex 12: Analytical Sieving) reached Step 2. The ICH Quality Implementation Working Group is developing a training program for workshops that will be held in the three ICH regions that will cover the ICH Guidelines Q8, Q9 and Q10 with the aim of achieving globally consistent implementation of ICH
Guidelines Q8, Q9 and Q10. This training will consist of case studies representing the four phases of the life cycle of a pharmaceutical product. The workshops will be held in Brussels in June 2010, in Washington, D.C. in October 2010 and in Tokyo in November 2010.

The ICH gene therapy experts met to begin work on the 1st ICH Guideline on “Viral and Gene Therapy Vector Shedding and Transmission”.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators Publish Q4B Annex9 & 10

Posted on September 30, 2009 by admin| Leave a comment

FDA Publishes Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions – Annex 9: Tablet Friability General Chapter

This annex is the result of the Q4B process for the Tablet Friability General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Full Text Here

FDA Publishes Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in ICH Regions – Annex 10: Polycrylamide Gel Electrophoresis General Chapter

This annex is the result of the Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter.  The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the official pharmacopoeial texts, the section in Ph.Eur. 2.2.31.  Electrophoresis entitled “Sodium Dodecyl Sulphate Polyacrylamide Gel Electrophoresis (SDS PAGE)”, JP General Information 23. SDS-Polyacrylamide Gel Electrophoresis, and USP <1056> Biotechnology-derived Articles – Polyacrylamide Gel Electrophoresis, can be used as 120 interchangeable in the ICH regions.

Full Text Here

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Development Regulations – Q4B Annex

Posted on July 16, 2009 by admin| Leave a comment

Drug Regulator, EMEA, publishes input into ICH Q4B Tablet Friability

EMEA publishes ANNEX 6 TO NOTE FOR EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON TABLET FRIABILITY GENERAL CHAPTER (EMEA/CHMP/ICH/379801/2009)

Analytical Procedures

The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.9.7. Friability of Uncoated Tablets, JP General Information 26. Tablet Friability Test, and USP <1216> Tablet Friability, can be used as interchangeable in the ICH regions.

Acceptance Criteria

For interchangeability, the loss of mass for a single determination should be not more than 1.0 percent, unless otherwise specified in the dossier. When three determinations are conducted, then the mean loss of mass for the three determinations should be not more than 1.0 percent, unless otherwise specified in the dossier.

EMEA publishes input into ICH Q4B Polyacrylamide Gel Electrophoresis

EMEA publshes ANNEX 6 TO NOTE FOR EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON POLYACRYLAMIDE GEL  ELECTROPHORESIS GENERAL CHAPTER (EMEA/CHMP/ICH/381133/2009)

Analytical Procedure

The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the official pharmacopoeial texts, the section in Ph.Eur. 2.2.31. Electrophoresis entitled “Sodium Dodecyl Sulphate Polyacrylamide Gel Electrophoresis (SDS-PAGE)”, JP General Information 23. SDS-Polyacrylamide Gel Electrophoresis, and USP <1056> Biotechnology-derived Articles – Polyacrylamide Gel Electrophoresis, can be used as interchangeable in the ICH regions.

Acceptance Criteria

The texts evaluated did not contain acceptance criteria

EMEA Publishes ICH input Q4B Sterility Test

The EMEA Publishes ANNEX 6 TO NOTE FOR EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON STERILITY TEST GENERAL CHAPTER (EMEA/CHMP/ICH/645592/2008)

Analytical Procedure

The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the official pharmacopoeial texts, Ph. Eur. 2.6.1. Sterility, JP 4.06 Sterility Test, and USP <71> Sterility Tests, can be used as interchangeable in the ICH regions subject to the conditions detailed below. Testing conditions for medical devices, such as sutures, are outside the scope of the ICH recommendation.

  • Diluting and rinsing fluids should not have antibacterial or antifungal properties if they are to be considered suitable for dissolving, diluting, or rinsing an article under test for sterility.
  • When testing liquid parenteral preparations with a nominal volume of 100 milliliters in batches of more than 500 containers, the test is considered interchangeable if the minimum number of containers selected is either 20 or is 2 percent of the total number of containers, whichever is lower.

Acceptance Criteria

The acceptance criteria are harmonized between the three pharmacopoeias.

EMEA Publishes ICH input on Q4B Disintigraion Test

The EMEA Publishes ANNEX 5 TO NOTE FOR EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON DISINTEGRATION TEST GENERAL CHAPTER (EMEA/CHMP/ICH/308895/2008)

Analytical Procedure

The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that for tablets and capsules, the official pharmacopoeial texts, Ph. Eur. 2.9.1. Disintegration of Tablets and Capsules, JP 6.09 Disintegration Test, and USP <701> Disintegration, can be used as interchangeable in the ICH regions subject to the conditions detailed below. Testing conditions for specific dosage forms are outside the scope of the harmonization of this chapter.

  • For tablets and capsules larger than 18 millimeters (mm) long for which a different apparatus is used, the Disintegration Test is not considered to be interchangeable in the three regions.
  • The Disintegration Test is not considered to be interchangeable in the three regions for dosage forms referred to in the regional compendia as delayed-release, gastro-resistant, or enteric-coated.
  • Product-specific parameters such as media and the use of discs should be specified in the application dossier.

Acceptance Criteria

Acceptance criteria are outside the scope of the harmonization of this chapter and should be specified in the application dossier.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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