WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 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. The international pharmacopoeia and related activities
Open this folder and view contents3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document4. Quality control methods for medicinal plant materials
View the document5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contents6. Good manufacturing practices for pharmaceutical products
View the document7. Development of globally acceptable standards for excipients
Close this folder8. Stability of dosage forms
View the document8.1. Survey
View the document8.2. Guidelines on stability testing of pharmaceutical products containing established drug substances
View the document9. Simple test methodology
View the document10. Quality assurance in pharmaceutical supply systems
Open this folder and view contents11. Pharmaceutical production in developing countries
View the document12. Training
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 - List of available International Chemical Reference Substances1
View the documentAnnex 2 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 3 - Good manufacturing practices for biological products1
View the documentBack Cover
 

8.1. Survey

The Committee discussed the results of the survey of products of questionable stability, which had been conducted as agreed at its thirty-second meeting (3). While the qualitative nature of the information received did not permit firm conclusions to be drawn concerning the magnitude of the problems related to the stability of the preparations surveyed, the following important general observations were made, based on an analysis of the data provided:

1. Over half the 200 reports received related to problems encountered with formulations of only five of the 25 drug substances included in the survey (acetylsalicylic acid, ampicillin, chloramphenicol, paracetamol, and tetracycline).

2. Many of the problems had been encountered with products well before their expiry dates, sometimes within a short time of their date of manufacture (in approximately 70% of cases where shelf-life data were available, the problem had occurred when less than half the shelf-life had elapsed and in approximately 45% of cases when less than one-quarter of the shelf-life had elapsed).


The above observations together with other information from the survey pointed to the existence of intrinsically unsatisfactory formulations of certain widely used drug substances. The poor quality would appear in many cases to be due to factors other than stability.

The Committee recommended that:

- the introduction to the initial summary report prepared by the Secretariat should be revised to reflect the much broader quality implications of the problems revealed by the survey;

- this initial report should be provided in the first instance to those who had participated in the survey;

- WHO should encourage those national authorities reporting problems to take appropriate action in relation to the suppliers of substandard products;

- in continuing to monitor the quality of products in their territories, all authorities should be encouraged to pay particular attention to the five widely used preparations mentioned in point 1 above;

- the data provided by participants should be analysed further by appropriate experts;

- future WHO action should be taken in the light of this analysis together with the results of the joint WHO/UNICEF study, endorsed by the Committee in its thirty-second report, on the quality of selected products at the point of use in developing countries;

- if it is decided to conduct a further survey, the questionnaire should be revised and refined in consultation with the relevant experts.

 

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