Guía ICH Q10
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BLOGS FARMACEUTICOS
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Formulation tools for pharmaceutical development - [image: https://www.facebook.com/#!/pages/Formulation-tools-for-pharmaceutical-development/802258473124226] I would like share with you my new Book *Form...
sábado, 8 de agosto de 2009
Automatizacion en control de los Procesos
La diferencia entre PAT y el control de procesos
Many Pharmaceutical Manufacturers Have Been Dragging Their Heels on Adopting Process Analytical Technology (PAT) Techniques for Years, but Now the Pressure Is On
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Many Pharmaceutical Manufacturers Have Been Dragging Their Heels on Adopting Process Analytical Technology (PAT) Techniques for Years, but Now the Pressure Is On
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lunes, 27 de julio de 2009
Acuerdo entre Agencias reguladoras sanitarias
La US Food and Drug Administration (FDA), la Australian Therapeutic Goods Administration (TGA) y el European Directorate for the Quality of Medicines and Health Care (EDQM) han establecido un acuerdo bilateral de confidencialidad, para compartir entre todos ellos información restringida sobre inspecciones a fabricantes de principios activos y de excipientes.
Estos acuerdos tiene como objetivo, facilitar la participación de las tres organizaciones en un proyecto piloto conjunto para harmonizar y racionalizar las prácticas de inspección internacionales, y el alcance de estos acuerdos incluye el intercambio de información interna y confidencial, relacionada con principios activos y excipientes utilizados en la fabricación de medicamentos.
Aquí también podéis consultar la lista de acuerdos de confidencialidad que tiene actualmente FDA con otras organizaciones.
Estos acuerdos tiene como objetivo, facilitar la participación de las tres organizaciones en un proyecto piloto conjunto para harmonizar y racionalizar las prácticas de inspección internacionales, y el alcance de estos acuerdos incluye el intercambio de información interna y confidencial, relacionada con principios activos y excipientes utilizados en la fabricación de medicamentos.
Aquí también podéis consultar la lista de acuerdos de confidencialidad que tiene actualmente FDA con otras organizaciones.
jueves, 18 de junio de 2009
Quo vadis GMP?
The USA have already made suggestions for updating the US-American GMP rules through their initiative "cGMP for the 21st Century". But what about Europe? The EC GMP Guide Part I dates back to the 80s. Part II (ICH Q7) is a product of the 90s. Even these two parts show obvious differences in comparable chapters. Revisions of various annexes have been conducted until today or are pending (e.g. Annexes 2 and 11). Changes have also been made to some chapters of the Guide itself (e. g. introduction of the Product Quality Review and of Risk Management in Chapter 1).
What comes next?
Perhaps the new GMP Guide of the Canadians could give us a hint to this? As a PIC/S member country and also as a country with a Mutual Recognition Agreement on GMP with the EU, Canada's GMP rules should also be of interest to the EU. Quite recently (8 May 2009) the Canadians' new GMP Guide was published. It comes into force on 8 November 2009. Details on the changes with regard to the original version of 2002 can be found here.
The now very comprehensive Guide consists of 102 pages (including 4 appendices, acronym list, glossary and references) in PDF format and has a slightly different structure than the EC GMP Guide. The manufacture of sterile medicinal products has e.g. been directly integrated into the Guide. The contents, however, are quite similar to those of Annex 1 (sometimes even the wording is identical).
The following list represents the table of contents of the 2009 version of the Canadian GMP rules:
TABLE OF CONTENTS
1.0 Introduction
2.0 Purpose
3.0 Scope
4.0 Quality Management
4.1 Guiding Principle
4.2 Relationship among Quality Elements
4.2.1 Quality Assurance
4.2.2 Good Manufacturing Practices (GMP) for Drugs
4.2.3 Quality Control .
5.0 Regulation
Sale
Premises
Equipment
Personnel
Sanitation
Raw Material Testing
Manufacturing Control
Quality Control Department
Packaging Material Testing
Finished Product Testing
Records
Samples
Stability
Sterile Products
Medical Gases
Appendix A Internationally Harmonized Requirements for Batch Certification
Appendix A1 Content of the Fabricator's/Manufacturer's Batch Certificate for Drug/Medicinal Products Exported to Countries under the Scope of a Mutual Recognition Agreement (MRA)
Appendix B
Acronyms
Glossary of Terms
Appendix C Annexes to the Current Edition of the Good Manufacturing Practices (GMP) Guidelines
References
Health Products and Food Branch Inspectorate - Operational Centres
The structure of the Canadian GMP Guide is very helpful for the reader, since - apart from the actual regulation - he or she also finds the corresponding rationale for this regulation as well as its interpretation. The requirements on equipment are e.g. described in a concise manner (cleanable, not contaminating the product, functional). The rationale then explains among others which types of contamination (dust, rust …) can occur for which reasons (misuse of the equipment, poor maintenance …). Finally, the interpretation requires among other things that validated CIP equipment must be easy to dismantle for periodic verification. Such detailed requirements cannot be found explicitly e.g. in the EC GMP Guide.
In the following you will find some examples for notable features of the new Canadian GMP rules:
For the identity testing of raw materials, a composite sample from 10 containers at the most is acceptable if a potency test is performed on this composite sample taking account of the mass balances. These concrete specifications are not to be found like this in the EC GMP Guide.
The responsibility for the timely performance of the annual Product Quality Review lies with quality control. This is certainly due to the fact that there is no Qualified Person defined in the Canadian regulations.
Archived documents have to be accessible within 48 hours. Such a concrete requirement cannot be found in the EC GMP Guide.
Metal surfaces of water systems should at least have "316 stainless steel" quality and should be passivated. We do not know such concrete requirements on water systems in official regulations in Europe.
The extent of revalidation work on water systems should be determined jointly by staff from quality control, engineering, production and further involved departments. In this context, the EC GMP Guide does not include such a concrete list of departments either.
Conclusion: The new Canadian GMP Guide is indeed worth reading and also provides detailed information on general GMP rules. In this respect, it could also give guidance to European firms where national or European GMP legislation does not specify any details. Naturally, this document is not legally binding for European companies.
Does it indicate where GMP is heading? For this, the alterations seem too moderate. From this perspective, the document rather represents a rung on the ladder of GMP evolution and may be seen as the Canadian authority's contribution to the Darwin anniversary year.
Here you can find the 2009 version of the Canadian GMP rules.
What comes next?
Perhaps the new GMP Guide of the Canadians could give us a hint to this? As a PIC/S member country and also as a country with a Mutual Recognition Agreement on GMP with the EU, Canada's GMP rules should also be of interest to the EU. Quite recently (8 May 2009) the Canadians' new GMP Guide was published. It comes into force on 8 November 2009. Details on the changes with regard to the original version of 2002 can be found here.
The now very comprehensive Guide consists of 102 pages (including 4 appendices, acronym list, glossary and references) in PDF format and has a slightly different structure than the EC GMP Guide. The manufacture of sterile medicinal products has e.g. been directly integrated into the Guide. The contents, however, are quite similar to those of Annex 1 (sometimes even the wording is identical).
The following list represents the table of contents of the 2009 version of the Canadian GMP rules:
TABLE OF CONTENTS
1.0 Introduction
2.0 Purpose
3.0 Scope
4.0 Quality Management
4.1 Guiding Principle
4.2 Relationship among Quality Elements
4.2.1 Quality Assurance
4.2.2 Good Manufacturing Practices (GMP) for Drugs
4.2.3 Quality Control .
5.0 Regulation
Sale
Premises
Equipment
Personnel
Sanitation
Raw Material Testing
Manufacturing Control
Quality Control Department
Packaging Material Testing
Finished Product Testing
Records
Samples
Stability
Sterile Products
Medical Gases
Appendix A Internationally Harmonized Requirements for Batch Certification
Appendix A1 Content of the Fabricator's/Manufacturer's Batch Certificate for Drug/Medicinal Products Exported to Countries under the Scope of a Mutual Recognition Agreement (MRA)
Appendix B
Acronyms
Glossary of Terms
Appendix C Annexes to the Current Edition of the Good Manufacturing Practices (GMP) Guidelines
References
Health Products and Food Branch Inspectorate - Operational Centres
The structure of the Canadian GMP Guide is very helpful for the reader, since - apart from the actual regulation - he or she also finds the corresponding rationale for this regulation as well as its interpretation. The requirements on equipment are e.g. described in a concise manner (cleanable, not contaminating the product, functional). The rationale then explains among others which types of contamination (dust, rust …) can occur for which reasons (misuse of the equipment, poor maintenance …). Finally, the interpretation requires among other things that validated CIP equipment must be easy to dismantle for periodic verification. Such detailed requirements cannot be found explicitly e.g. in the EC GMP Guide.
In the following you will find some examples for notable features of the new Canadian GMP rules:
For the identity testing of raw materials, a composite sample from 10 containers at the most is acceptable if a potency test is performed on this composite sample taking account of the mass balances. These concrete specifications are not to be found like this in the EC GMP Guide.
The responsibility for the timely performance of the annual Product Quality Review lies with quality control. This is certainly due to the fact that there is no Qualified Person defined in the Canadian regulations.
Archived documents have to be accessible within 48 hours. Such a concrete requirement cannot be found in the EC GMP Guide.
Metal surfaces of water systems should at least have "316 stainless steel" quality and should be passivated. We do not know such concrete requirements on water systems in official regulations in Europe.
The extent of revalidation work on water systems should be determined jointly by staff from quality control, engineering, production and further involved departments. In this context, the EC GMP Guide does not include such a concrete list of departments either.
Conclusion: The new Canadian GMP Guide is indeed worth reading and also provides detailed information on general GMP rules. In this respect, it could also give guidance to European firms where national or European GMP legislation does not specify any details. Naturally, this document is not legally binding for European companies.
Does it indicate where GMP is heading? For this, the alterations seem too moderate. From this perspective, the document rather represents a rung on the ladder of GMP evolution and may be seen as the Canadian authority's contribution to the Darwin anniversary year.
Here you can find the 2009 version of the Canadian GMP rules.
sábado, 13 de junio de 2009
Nuevos requerimientos para el Agua Purificada
Current Ph.Eur. Requirements on Pharmaceutical Water
With the Supplement 6.3 to the European Pharmacopoeia, some changes with regard to water for pharmaceutical use came into force in 2009. They affect water for injection (WFI), highly purified water (HPW) as well as purified water (PW).
Basically, the changes are the same for all three water qualities. WFI is an exception; in the section on sterilised water for injection, the tests for oxidizable substances and ammonium are also concerned. For both testing procedures, there is now a distinction between containers larger or smaller than 50 ml.
What is identical for all three water qualities is the introduction of the new section on microbiological monitoring. Apart from mentioning the action value of 100 CFU/ml respectively 10 CFU/100 ml (limits unchanged), exact types of test strains, growth conditions and the agar to be used have been taken over.
The more detailed description of conductivity measurement, too, can be found in all three qualities. With regard to the conductivity cell, there is now a note that the cell constant has to be certified by the supplier and that this has to be calibrated regularly against a certified reference solution or against a conductivity cell with certified cell constant.
However, the most important change is certainly the long-awaited cancellation of the test for heavy metals, since this test point is covered by the conductivity measurement. This also concerns all three water qualities mentioned, with the exception that the test can only be dropped for purified water in case conductivity testing fulfils the requirements on WFI (bulk). This is a further step towards a harmonisation with the American pharmacopoeia (USP).
With the Supplement 6.3 to the European Pharmacopoeia, some changes with regard to water for pharmaceutical use came into force in 2009. They affect water for injection (WFI), highly purified water (HPW) as well as purified water (PW).
Basically, the changes are the same for all three water qualities. WFI is an exception; in the section on sterilised water for injection, the tests for oxidizable substances and ammonium are also concerned. For both testing procedures, there is now a distinction between containers larger or smaller than 50 ml.
What is identical for all three water qualities is the introduction of the new section on microbiological monitoring. Apart from mentioning the action value of 100 CFU/ml respectively 10 CFU/100 ml (limits unchanged), exact types of test strains, growth conditions and the agar to be used have been taken over.
The more detailed description of conductivity measurement, too, can be found in all three qualities. With regard to the conductivity cell, there is now a note that the cell constant has to be certified by the supplier and that this has to be calibrated regularly against a certified reference solution or against a conductivity cell with certified cell constant.
However, the most important change is certainly the long-awaited cancellation of the test for heavy metals, since this test point is covered by the conductivity measurement. This also concerns all three water qualities mentioned, with the exception that the test can only be dropped for purified water in case conductivity testing fulfils the requirements on WFI (bulk). This is a further step towards a harmonisation with the American pharmacopoeia (USP).
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