Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Close this folder4. The international pharmacopoeia and related activities
View the documentGuidance for those preparing or commenting on monographs for preparations to be included in The international pharmacopoeia1
View the documentValidation of analytical procedures used in the examination of pharmaceutical materials1
Close this folderGeneral guidelines for the establishment, maintenance, and distribution of chemical reference substances1
View the document1. Criteria for determining the need for the establishment of chemical reference substances
View the document2. Evaluation of reference substances
Open this folder and view contents3. Chemical and physical methods used in evaluating reference substances
Close this folder4. Handling and distribution of reference substances
View the document4.1 Packing and storage
View the document4.2 Stability and periodic re-evaluation
View the document4.3 Information to be supplied with reference substances
View the document4.4 Expiry of reference substances
View the document4.5 Distribution problems
View the document5. Reference materials calibrated against International Chemical Reference Substances
View the document6. Means of promoting effective exchange of information and ensuring cooperation between organizations establishing reference substances
View the documentGeneral recommendations for the preparation and use of infrared spectra in pharmaceutical analysis1
View the documentList of available International Chemical Reference Substances1
View the documentList of available International Infrared Reference Spectra1
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
4.3 Information to be supplied with reference substances

Some centres for reference materials supply extensive documentation with the reference substances, and include directions for use. Other centres supply no information except the name of the substance and of the issuing authority. Such differing practices may result in improper use of the reference substances. It is desirable that recommendations should be made concerning the information to be supplied with reference substances and its manner of expression.

Labels on chemical reference substances should give the following information:

(a) name of the substance;

(b) type of reference substance (e.g. International Chemical Reference Substance, or National Chemical Reference Substance, or Authentic Specimen);

(c) name and address of the issuing authority;

(d) approximate quantity of material in the container; and

(e) batch or control number.

The following information should be given, as necessary, either on the labels or in associated documents:

(i) recommended storage conditions (if special conditions apply, these should be given on the label);

(ii) intended use of the reference substances;

(iii) directions for use (e.g. instructions about drying the material before use and any necessary cautionary statements);

(iv) information about the composition of the reference substance, which is needed for calculation of the results of tests in which the substance will be used; and

(v) a disclaimer of responsibility when reference substances are misused, or stored under inappropriate conditions, or used for other purposes than those intended by the issuing authority.

It is recommended that the analytical data given in the certificates supplied with the reference substances should be restricted to what is necessary for the proper use of the substances in the tests and assays for which they are provided. The full analytical reports, should, however, be available when needed for evaluation of the suitability of the reference substances for uses other than those originally intended. It might also be desirable to give more general information about the reference substances concerned, either on separate leaflets or incorporated in the certificates.

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