WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. General policy
Open this folder and view contents3. Quality control - specifications and tests
View the document4. Quality control - international reference materials
Open this folder and view contents5. Quality control - national laboratories
Open this folder and view contents6. Quality assurance - good manufacturing practices
Open this folder and view contents7. Quality assurance - inspection
Open this folder and view contents8. Quality assurance - distribution and trade-related
Open this folder and view contents9. Quality assurance - risk analysis
Open this folder and view contents10. Quality assurance - drug supply
Open this folder and view contents11. Quality assurance - storage
View the document12. International Nonproprietary Names (INNs) programme
Open this folder and view contents13. Miscellaneous
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the documentAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Open this folder and view contentsAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
Open this folder and view contentsAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
View the documentAnnex 5 Model certificate of Good Manufacturing Practices
View the documentAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
View the documentAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Open this folder and view contentsAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Close this folderAnnex 9 Guide to good storage practices for pharmaceuticals1
View the document1. Introduction
View the document2. Glossary
View the document3. Personnel
View the document4. Premises and facilities
View the document5. Storage requirements
View the document6. Returned goods
View the document7. Dispatch and transport
View the document8. Product recall
View the documentReferences
View the documentBibliography
View the documentAppendix Storage and labelling conditions2
View the documentBack cover
 

Appendix Storage and labelling conditions2

2 The text was adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its 34th meeting (WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-Fourth report. Geneva, World Health Organization, 1996, Annex 5 (WHO Technical Report Series No. 863).


Normal storage conditions

Storage in dry, well-ventilated premises at temperatures of 15 - 25 °C or, depending on climatic conditions, up to 30 °C. Extraneous odours, other indications of contamination, and intense light must be excluded.

Defined storage instructions

Drug products that must be stored under defined conditions require appropriate storage instructions. Unless otherwise specifically stated (e.g. continuous maintenance of cold storage) deviation may be tolerated only during short-term interruptions, for example, during local transportation.

The use of the following labelling instructions are recommended:

On the label

Means

“Do not store over 30 °C”

from +2 °C to +30 °C

“Do not store over 25 °C”

from +2 °C to +25 °C

“Do not store over 15 °C”

from +2 °C to +15 °C

“Do not store over 8 °C”

from +2 °C to +8 °C

“Do not store below 8 °C”

from +8 °C to +25 °C

“Protect from moisture”

no more than 60% relative humidity in normal storage conditions; to be provided to the patient in a moisture- resistant container.

“Protect from light”

to be provided to the patient in a light-resistant container.

SELECTED WHO PUBLICATIONS OF RELATED INTEREST

The international pharmacopoeia, third edition.

Volume 1: general methods of analysis. 1979 (223 pages)

Volume 2: quality specifications. 1981 (342 pages)

Volume 3: quality specifications. 1988 (407 pages)

Volume 4: tests, methods, and general requirements: quality specifications for pharmaceutical substances, excipients, and dosage forms. 1994 (358 pages)

Volume 5: tests and general requirements for dosage forms. Quality specifications for pharmaceutical substances and dosage forms. (in press)

Basic tests for drugs: pharmaceutical substances, medicinal plant materials and dosage forms.

1998 (94 pages)

Basic tests for pharmaceutical dosage forms.

1991 (134 pages)

Quality assurance of pharmaceuticals: a compendium of guidelines and related materials.

Volume 1: 1997 (244 pages)

Volume 2: good manufacturing practices and inspection. 1999 (201 pages)

Quality control methods for medicinal plant materials.

1998 (123 pages)

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

Thirty-sixth report.

WHO Technical Report Series, No. 902, 2002 (215 pages)

International nonproprietary names (INN) for pharmaceutical substances. Cumulative list no. 10.

2002 (available in CD-ROM format only)

The use of essential drugs.

Ninth report of the WHO Expert Committee (including the revised Model List of Essential Drugs).

WHO Technical Report Series, No. 895, 2000 (66 pages)

WHO Expert Committee on Biological Standardization.

Fiftieth report.

WHO Technical Report Series, No. 904, 2002 (113 pages)

Further information on these and other WHO publications can be obtained from Marketing and Dissemination, World Health Organization, 1211 Geneva 27, Switzerland

 

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