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This annex is the result of the Q4B process for the Bulk Density and Tapped Density of Powders 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. 2.9.34. Bulk Density and Tapped Density of Powders, JP 3.01 Determination of Bulk and Tapped Densities, and USP General Chapter <616> Bulk Density and Tapped Density of Powders, can be used as interchangeable in the ICH regions subject to the following conditions:

For Bulk Density Method 2, the tolerance of the cup volume should be 16.39 ±0.20 milliliters (mL).
For Tapped Density Method 3, the test conditions, including tapping height, should be specified in the results.
For Measures of Powder Compressibility, if V10 is used, it should be clearly stated in the results.

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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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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 <786> Particle Size Distribution Estimation by Analytical Sieving, can be used as interchangeable in the ICH regions.

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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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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, can be used as interchangeable in the ICH regions.

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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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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).
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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“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.”

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).

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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“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.”

Full Text Here

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

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The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use, steering committee and expert working groups met in Yokohama in June (6th to 11th) and a number of highlights are outlined  below. What the ICH agree will shape the regulations to come.

Non-Clinical Safety

A significant milestone was achieved in Yokohama with the finalization of the revision of the M3 Guideline “Non-clinical Safety Studies for the Conduct of Human Clinical Trials and for Marketing Authorizations”. The new M3 Guideline promotes more rapid discovery and development of innovative medicines, by reducing the reliance on animals required in drug development studies. These efforts continue ICH’s commitment to the 3Rs (Reduction, Refinement and Replacement) of animal testing.

Clinical Safety and Efficacy

The ICH Guideline E16 “Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions” reached Step 2. The guideline provides recommendations on the context, structure and format of regulatory submissions for genomic biomarker qualification in order to facilitate submission and review of biomarker qualification data among regions. Public comments on the ICH Guideline E2F “Developmental Safety Update Reports” have been taken into account and made good progress toward Step 4. The guideline will harmonize the requirements for annual clinical trial reporting to the regulators in the three regions and will provide an additional level of protection for patients in clinical trials.

Quality of Pharmaceuticals

Progress was made on the harmonization of pharmacopoeia texts in the three regions, which will reduce testing requirements for the industry. Two annexes to the Q4B Guideline (Annex 5 on “Disintegration Test” and Annex 8 on “Sterility Test”) reached Step 4 and another two (Annex 9 on “Tablet Friability” and Annex 10 on “PAGE”) reached Step 2. The Quality Implementation Working Group delivered a set of Q&As to answer questions arising from the Q8, Q9, and Q10 Guidelines. Also of note, was a meeting of the Q11 Expert Working Group “Development and Manufacture of Drug Substances,” covering both chemical and biological substances with wider participation from some non-ICH countries. Work on the topic continued to progress.

The next ICH meeting will be held in St. Louis, MO, USA from October 24-29, 2009.

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