Technical Report Series articles from January 1 2009

Technical Report Series archives from January 1 2009

2. General policy.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 2.1 Collaboration with international organizations and agencies 2.1.1 The Global Fund to Fight AIDS, Tuberculosis and Malaria The Expert Committee was informed that the main objective of the Global Fund to Fight AIDS, Tuberculosis and...

3. Joint session with the Expert Committee on Biological Standardization.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... During the meeting, a joint session was held with the Expert Committee on Biological Standardization (ECBS) at which a number of matters of common interest, set out below, were discussed. The Expert Committee on Specifications for...

4. Quality control--specifications and tests.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 4.1 The International Pharmacopoeia The Committee was pleased to note that the First Supplement to the Fourth Edition of The International Pharmacopoeia had recently been published in both book form and electronically (as a replacement...

5. Quality control--International Reference materials (International Chemical Reference Substances and International Infrared Reference Spectra).(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 5.1 Annual reports of the WHO Collaborating Centre The Committee noted with appreciation the work of the WHO Collaborating Centre for Chemical Reference Substances as presented in its report for 2007. It was noted that the number of...

6. Quality control--national laboratories.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 6.1 External Quality Assurance Assessment Scheme With a view to continuing the promotion of quality assurance in pharmaceutical quality control laboratories in WHO Member States, four test series in phase 4 of the proficiency testing scheme...

7. Quality assurance--good manufacturing practices.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 7.1 Good manufacturing practices for biologicals The Committee supported collaboration between the two Expert Committees (Specifications for Pharmaceutical Preparations, and Biological Standardization) in the area of GMP for biologicals....

8. Quality assurance--new approaches and risk analysis.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 8.1 Information sharing and collaboration Strategies on how best to cope with the increasing need for inspections by national and regional bodies had been discussed in many forums. This topic had also been discussed during several WHO...

9. Quality assurance--distribution and trade of pharmaceuticals.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce The WHO Certification Scheme for finished pharmaceutical products was an international voluntary agreement to provide assurance to countries...

10. Quality assurance--stability.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... The revised working document on Draft Stability testing of active pharmaceutical ingredients and finished pharmaceutical products was presented to the Expert Committee. A brief history of this guidance document and the various related...

11. Prequalification of priority essential medicines and devices.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 11.1 Prequalification Programme managed by WHO The Prequalification Programme, set up in 2001, is a service provided by WHO to facilitate access to medicines for HIV/AIDS, malaria and tuberculosis, which met unified standards of quality, safety...

12. Prequalification of quality control laboratories.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)(Brief article)
January 1, 2009... The prequalification of quality control laboratories is undertaken by WHO together with UNICEF, UNAIDS, UNFPA and UNITAID and with the support of the World Bank. The procedure started in 2004 when participation was limited to laboratories in...

13. Prequalification of active pharmaceutical ingredients.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)(Brief article)
January 1, 2009... 13.1 Procedure for prequalification of active pharmaceutical ingredients The need for quality assurance of APIs, as requested by Member States, was discussed by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its...

14. Regulatory guidance.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 14.1 Specific regulatory guidance on paediatric medicines Based on recommendations made by the Expert Committee at its forty-second meeting, a paper was prepared to provide guidance on the formulation of paediatric medicines. The guidance...

15. Nomenclature, terminology and databases.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 15.1 Quality assurance terminology The database, available on the WHO quality assurance web site: http://www.who.int/medicines/areas/quality_safety/quality_assurance/en/was presented to the Committee. The Committee emphasized the importance...

16. Miscellaneous.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 16.1 Draft WHO Medicines Strategy 2008-2013 Late in 2007 the Director-General announced her intention to combine the Department of Medicines Policy and Standards and the Department of Technical Cooperation for Essential Drugs and Traditional...

17. Summary and recommendations.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... On the occasion of the 60th anniversary of the World Health Organization, the WHO Expert Committee on Specifications for Pharmaceutical Preparations was able to look back on its existence and activities even before that date. The first meeting...

Acknowledgements.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... Special acknowledgement was made by the Committee to Mrs W. Bonny, Dr S. Kopp, Ms C. Mendy, Ms M.-L. Rabouhans and to Dr L. Rago, Quality Assurance and Safety: Medicines, Essential Medicines and Pharmaceutical Policies, WHO, Geneva, Switzerland,...

Annex 2: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 1. Introduction 1.1 Objectives of these guidelines 1.2 Scope of these guidelines 1.3 General principles 2. Guidelines 2.1 Active pharmaceutical ingredient 2.1.1 General 2.1.2 Stress testing 2.1.3 Selection of...

Appendix 1: Long-term stability testing conditions as identified by WHO member states.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)(World Health Organization)
January 1, 2009... In order to be able to reduce the amount of stability testing required, the number of different long-term testing conditions must be reduced to a sufficient extent. This approach was proposed by Paul Schumacher in 1972 (1) and by Wolfgang Grimm...

Appendix 2: Examples of testing parameters.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... Section I for active pharmaceutical ingredients In general, appearance, assay and degradation products should be evaluated for all active pharmaceutical ingredients (APIs). Other API parameters that may be susceptible to change should also be...

Appendix 3: Recommended labelling statements.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 1. Active pharmaceutical ingredients The statements that should be used if supported by the stability studies for active pharmaceutical ingredients (APIs) are listed in Table 1. 2. Finished pharmaceutical products The statements that...

Annex 3: Procedure for prequalification of pharmaceutical products.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 1. Introduction 2. Glossary 3. Purpose and principles 4. Steps of the procedure 5. Invitation for expressions of interest 6. Data and information to be submitted 7. Screening of dossiers submitted 8. Dossier assessment 9....

Annex 4: Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products.(WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS)
January 1, 2009... 1. Introduction A significant part of the quality of a finished pharmaceutical product (FPP) is dependent on the quality of the active pharmaceutical ingredients (APIs) used for its production. Under the World Health Organization (WHO)...