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

Format:

Book

Government document

Author/Creator:

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting (37th : 2001 : Geneva, Switzerland)

Series:

Technical report series (World Health Organization) ; 908.

WHO technical report series, 0512-3054 ; 908

Language:

English

Subjects (All):

Drugs--Standards--Congresses.

Drugs.

Drugs--Specifications--Congresses.

Pharmaceutical industry--Quality control--Congresses.

Pharmaceutical industry.

Physical Description:

1 online resource (145 p.)

Edition:

1st ed.

Place of Publication:

Geneva : World Health Organization, 2003.

Language Note:

English

Summary:

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available international chemical reference substances and international infrared spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guideli

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 (GMP)

7. Quality assurance

inspection

8. Quality assurance

distribution and trade-related

9. Quality assurance

risk analysis

10. Quality assurance

drug supply

11. Quality assurance

storage

12. International Nonproprietary Names (INNs) Programme

13. Miscellaneous

Annex 1. Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products

Annex 2. The International Pharmacopoeia: revised concepts and future perspectives

Annex 3. Guidelines on good manufacturing practices for radiopharmaceutical products

Annex 4. Good manufacturing practices for pharmaceutial products: main prinicples

Annex 5. Model certificate of good manufacturing practices

Annex 6. Guidance on good manufacturing practices (GMP): inspection report

Annex 7. Application of hazard analysis and critical control point (HACCP) method to pharmaceuticals

Annex 8. Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies

Annex 9. Guide to good storage practices for pharmaceuticals.

Notes:

Description based upon print version of record.

ISBN:

1-280-01133-5

92-4-068157-4

9786610011339

OCLC:

191039475