WHO Expert Committee on Specifications for Pharmaceutical Preparations : thirty-ninth report.

Format:

Book

Government document

Author/Creator:

WHO Expert Committee on Specifications for Pharmaceutical Preparations, Corporate Author.

Contributor:

World Health Organization.

WHO Expert Committee on Specifications for Pharmaceutical Preparations 2004 : Geneva, Switzerland)

Series:

Technical report series (World Health Organization) ; 929.

WHO technical report series ; 929

Language:

English

Subjects (All):

Drugs--Standards--Congresses.

Drugs.

Pharmacopoeias--Congresses.

Pharmacopoeias.

Drugs--Quality control--Congresses.

Physical Description:

1 online resource (149 p.)

Edition:

1st ed.

Place of Publication:

Geneva : World Health Organization, 2005.

Language Note:

English

Summary:

This report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices, inspection, distribution and trade, and other aspects of quality assurance of pharmaceuticals, and regulatory issues. Several annexes include an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products, and draft guidelines for registration of fixed-dose combination medicinal products.

Contents:

Preliminaries; Contents; 1 Introduction; 2 General policy; 3 Quality control specifications and tests; 4 Quality control International Reference Materials; 5 Quality control national laboratories; 6 Quality assurance good manufacturing practices; 7 Quality assurance inspection; 8 Quality assurance distribution and trade related; 9 Quality assurance risk analysis; 10 Quality assurance stability; 11 Quality assurance drug supply; 12 Regulatory guidance on interchangeability for multisource medicines; 13 Fixed dose combination products for priority communicable diseases

14 International Nonproprietary Names15 Summary and recommendations; Acknowledgements; International Chemical Reference Substances and International Infrared Reference Spectra1; Good manufacturing practices: requirement for the sampling of starting materials amendment; WHO Good Manufacturing Practices water for pharmaceutical use; WHO guidelines for sampling of pharmaceutical products and related materials; Guidelines for registration of fi

Notes:

"WHO Expert Committee on Specifications for Pharmaceutical Preparations, Geneva, 25-29 October 2004"--P. v.

Includes bibliographical references.

ISBN:

1-280-43616-6

9786610436163

92-4-068156-6

OCLC:

476035356