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
Open this folder and view contents8. Stability of dosage forms
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
Close this folderAnnex 3 - Good manufacturing practices for biological products1
View the document1. Scope of these guidelines
View the document2. Principles
View the document3. Personnel
View the document4. Premises and equipment
View the document5. Animal quarters and care1
View the document6. Production
View the document7. Labelling
View the document8. Lot processing records (protocols) and distribution records
View the document9. Quality assurance and quality control
View the documentAuthors
View the documentAcknowledgements
View the documentReferences
View the documentBack Cover
 

7. Labelling

7.1 All products shall be clearly identified by labels. The labels used must remain permanently attached to the containers under all storage conditions and an area of the container should be left uncovered to allow inspection of the contents. If the final container is not suitable for labelling (for example a capillary tube), it should be in a labelled package.

7.2 The information given on the label on the container and the label on the package shall be approved by the national control authority.

7.3 The label on the container shall show:

- the name of the drug product;

- a list of the active ingredients and the amount of each present, with a statement of the net contents, e.g. number of dosage units, weight or volume;

- the batch or final lot number assigned by the manufacturer;

- the expiry date;

- recommended storage conditions or handling precautions that may be necessary;

- directions for use, and warnings and precautions that may be necessary;

- the nature and amount of any substance used in the preparation of the biological product that is likely to give rise to an adverse reaction in some recipients;

- the name and address of the manufacturer or the company and/or the person responsible for placing the drug on the market.


7.4 The label on the package shall, in addition to the information shown on the label on the container, show at least the nature and amount of any preservative or additive in the product.

7.5 The leaflet in the package should provide instructions for the use of the product, and mention any contraindications or potential adverse reactions.

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