Selected WHO publications of related interest

Basic Tests for Drugs
Pharmaceutical Substances, Medicinal Plant Materials and Dosage Forms
1998, iii + 91 pages [E, F*, S*]
ISBN 92 4 154513 5
Sw.fr. 26.-/US$23.40
In developing countries: Sw.fr. 18.20
Order no. 1150462

Describes tests for 23 pharmaceutical substances and 58 pharmaceutical dosage forms, most of which are included in the WHO Model List of Essential Drugs. Basic tests for confirming the identity of four commonly used medicinal plant materials are also included.

Basic Tests for Pharmaceutical Dosage Forms
1991, v + 129 pages [C, E, F, S]
ISBN 92 4 154418 X
Sw.fr. 24.-/US$21.60
In developing countries: Sw.fr. 16.80
Order no. 1150359

Sets out rapid screening tests required to verify the identity of some 150 pharmaceutical dosage forms in common use. The tests, which are simple and readily applicable, make it possible to confirm the identity of pharmaceutical substances in tablet, capsule, solution, lotion and other forms in those cases where quality is in doubt. The basic tests may also be applied to determine whether gross degradation has occurred despite high standards of packaging.

“... describes simple tests of powerful use in the primary detection of degradation, tampering, adulteration, and counterfeiting... admirably serves its purpose...”

- Journal of the Royal Society of Health

Basic Tests for Pharmaceutical Substances
1986, 210 pages [Ar, C, E, F, S]
ISBN 92 4 154204 7
Sw.fr. 34.-/US$30.60
In developing countries: Sw.fr. 23.80
Order no. 1150245

Presents simplified tests for verifying the identify of pharmaceutical substances and detecting gross degradation. The 321 substances covered represent the majority of drug substances contained in the WHO Model List of Essential Drugs as well as a number of other widely used drug substances. For each, tests have been devised to serve as a simple and readily applicable method of verification of identity when a fully equipped laboratory is not available.

“... will serve as a useful component of the WHO programme for quality assurance in the pharmaceutical supply system...”

- Indian Journal of Hospital Pharmacy

The International Pharmacopoeia, Third Edition
Volume 1: General Methods of Analysis
1979, 223 pages [E, F, S]
ISBN 92 4 154150 4
Sw.fr. 24.-/US$21.60
In developing countries: Sw.fr. 16.80
Order no. 1151091

Describes 42 methods and procedures for the quality control of pharmaceutical substances and dosage forms.

“... a very useful laboratory aid...”

- International Journal of Crude Drug Research

The International Pharmacopoeia, Third Edition
Volume 2: Quality Specifications
1981, 342 pages [E, F, S]
ISBN 92 4 154151 2
Sw.fr. 36.-/US$32.40
In developing countries: Sw.fr. 25.20
Order no. 1152091

Contains quality specifications for 126 pharmaceutical substances included in the WHO Model List of Essential Drugs. The specifications are especially suited to quality control in developing countries.

“... deserves due international recognition as a basis for standardising drug quality control procedures...”

- The Pharmaceutical Journal

The International Pharmacopoeia, Third Edition
Volume 3: Quality Specifications
1988,407 pages [E, F, R, S]
ISBN 92 4 154215 2
Sw.fr. 64.-/US$57.60
In developing countries: Sw.fr. 44.80
Order no. 1153091

Presents quality specifications for 157 widely used pharmaceutical substances. Monographs are based on sound, classical chemical methods appropriate for use in small and medium-sized laboratories.

“... helps enhance the applicability of the Pharmacopoeia to a large range of laboratory settings...”

- Journal of Pharmacy Technology

The International Pharmacopoeia, Third Edition
Volume 4: Tests, Methods, and General Requirements; Quality Specifications for Pharmaceutical Substances, Excipients, and Dosage Forms
1994, xv + 343 pages [E, F, S]
ISBN 92 4 154462 7
Sw.fr. 85.-/US$76.50
In developing countries: Sw.fr. 59.50
Order no. 1154091

A collection of recommended quality specifications and methods of analysis for selected pharmaceutical products, excipients, and dosage forms.

WHO Expert Committee on Specifications for Pharmaceutical Preparations
Thirty-fourth Report
Technical Report Series, No. 863
1996, vi + 194 pages [E, F, S*]
ISBN 92 4 120863 5
Sw.fr. 35.-/US$31.50
In developing countries: Sw.fr. 24.50
Order no. 1100863

Sets out a series of twelve international guidelines and other recommendations intended to assist national drug regulatory authorities and manufacturers in the quality control of pharmaceutical products. Concerns addressed include the need to ensure that pharmaceutical products moving in international commerce are of acceptable quality, that generic drugs are therapeutically equivalent to innovator products, and that drugs retain their quality, safety, and efficacy throughout their designated shelf-life, particularly under the extreme climatic conditions often found in developing countries. The report also responds to the need to extend previously issued WHO guidelines for good manufacturing practices (GMP) to cover several special circumstances.

WHO Expert Committee on Specifications for Pharmaceutical Preparations
Thirty-fifth Report
Technical Report Series. No. 885
1999, vi + 156 pages [E, F*, S*]
ISBN 92 4 120885 6
Sw.fr. 35.-/US$31.50
In developing countries: Sw.fr. 24.50
Order no. 1100885

Provides a progress report on a number of WHO activities intended to support a comprehensive approach to the quality assurance of pharmaceutical products. Although the report has global relevance, its guidance is of particular importance in countries attempting to establish or strengthen a regulatory framework for pharmaceutical products. All recommendations share the ultimate goal of helping regulatory authorities safeguard the health of patients by protecting them from substandard or counterfeit products.

World Health Organization
Marketing and Dissemination
CH-1211 Geneva 27, Switzerland
Tel.: +41 22 791 2476, fax: + 41 22 791 4857
Email for orders: bookorders@who.ch