Technical Report Series articles from April 2006

Technical Report Series archives from April 2006

WHO Expert Committee on specifications for pharmaceutical preparations: Geneva, 24-28 October 2005.
April 1, 2006... Members * Professor I. Addae-Mensah, Professor of Chemistry, University of Ghana, Legon, Accra, Ghana Dr H. Beltramini, Director, Planification and Institutional Relations--Drugs, Food and Medical Devices, National Administration,...

Annex 1: list of available International Chemical Reference Substances and International Infrared Reference Spectra.
April 1, 2006... 1. International Chemical Reference Substances International Chemical Reference Substances (ICRS) are established upon the advice of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are supplied primarily for...

Annex 2: supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms.(Table)
April 1, 2006... 1. Introduction 2. Scope of document 3. Glossary 4. Protection 4.1 Products and personnel 4.2 Air filtration 4.3 Unidirectional airflow 4.4 Infiltration 4.5 Cross-contamination 4.6 Temperature and...

Annex 3: supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines.(Table)
April 1, 2006... Introduction General Glossary 1. Quality assurance in the manufacture of herbal medicines 2. Good manufacturing practice for herbal medicines 3. Sanitation and hygiene 4. Qualification and validation 5....

Annex 4: supplementary guidelines on good manufacturing practices: validation.(Table)
April 1, 2006... 1. Introduction 2. Scope 3. Glossary 4. Relationship between validation and qualification 5. Validation 5.1. Approaches to validation 5.2. Scope of validation 6. Qualification 7. Calibration and verification 8. Validation...

Annex 4: supplementary guidelines on good manufacturing practices: validation.(Appendix 6-Appendix 7)
April 1, 2006... Appendix 6 Qualification of systems and equipment 1. Principle 2. Scope 3. General 4. Design qualification 5. Installation qualification 6. Operational qualification 7. Performance qualification 8. Requalification 9....

Annex 5: good distribution practices for pharmaceutical products.
April 1, 2006... 1. Introduction 2. Scope of the document 3. Glossary 4. Organization and management 5. Personnel 6. Quality management 7. Premises, warehousing and storage 8. Vehicles and equipment 9. Shipment containers and...

Annex 6: a model quality assurance system for procurement agencies (Recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products).(Table)
April 1, 2006... Introduction Glossary Module I. General requirements for procurement agencies Introduction I.1 Physical resources I.1.1 Premises I.1.2 Equipment I.1.3 Materials and consumables I.1.4 Financial...

Annex 6: a model quality assurance system for procurement agencies (Recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products).
April 1, 2006... Module IV Receipt and storage of purchased products Introduction The procurement agency should ensure that the pharmaceutical products purchased are received and stored correctly and in compliance with applicable legislation and...

Annex 6: a model quality assurance system for procurement agencies (Recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products).
April 1, 2006... Appendix 7 Example of a standard operating procedure for screening and assessing product information 1. Title Assessing product files Signature Date Prepared by 9 May 2005 Authorized...

Annex 7: multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability.
April 1, 2006... 1. Introduction 2. Glossary 3. Documentation of equivalence for marketing authorization 4. When equivalence studies are not necessary 5. When in vivo equivalence studies are necessary and types of studies required ...

Annex 8: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms.(World Health Organization)
April 1, 2006... Introduction 1. Background 2. WHO revisions to the criteria for Biopharmaceutics Classification System classification 3. WHO extensions to the scope of application of the biowaiver 4. WHO additional criteria for...

Annex 9: additional guidance for organizations performing in vivo bioequivalence studies.
April 1, 2006... Introduction 1. Scope 2. Glossary 3. Organization and management 4. Computer systems Hardware Software Data management 5. Archive facilities 6. Premises 7. Clinical phase 8. Clinical...