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

9. Quality assurance and quality control

9.1 The quality assurance and/or quality control department should have the following principal duties:

- to prepare detailed instructions for each test and analysis;

- to ensure adequate identification and segregation of test samples to avoid mix-up and cross-contamination;

- to ensure that environmental monitoring and equipment validation are conducted as appropriate for evaluating the adequacy of the manufacturing conditions;

- to release or reject raw materials and intermediate products, if necessary;

- to release or reject packaging and labelling materials and the final containers in which drugs are to be placed;

- to release or reject each lot of finished preparation;

- to evaluate the adequacy of the conditions under which raw materials, intermediate products and finished biological preparations are stored;

- to evaluate the quality and stability of finished products and, when necessary, of raw materials and intermediate products;

- to establish expiry dates on the basis of the validity period related to specified storage conditions;

- to establish and, when necessary, revise control procedures and specifications; and

- to be responsible for the examination of returned preparations to determine whether such preparations should be released, reprocessed or destroyed; adequate records of the distribution of such preparations should be maintained.

9.2 A manufacturer’s quality control laboratory shall be separated from the production area and ideally should be in a separate building. The control laboratory should be designed and equipped and of such a size as to be a self-contained entity, with adequate provision for the storage of documents and samples, preparation of records and performance of the necessary tests.

9.3 In-process controls play a specially important role in ensuring the consistent quality of biological products. Tests that are crucial for quality control but that cannot be carried out on the finished product shall be performed at an appropriate stage of production.

9.4 Performance of all qualitative and quantitative tests mentioned in the specifications for starting materials may be replaced by a system of certificates issued by the producer of the starting material, provided that:

- there is a history of reliable production,
- the producer is regularly audited, and
- at least one specific identity test is conducted by the manufacturer of the final product.

9.5 Samples of intermediate and final products shall be retained in sufficient amount and under appropriate storage conditions to allow the repetition or confirmation of a batch control. However, reference samples of certain starting materials, e.g. components of culture media, need not necessarily be retained.

9.6 Certain operations require the continuous monitoring of data during a production process, for example monitoring and recording of physical parameters during fermentation.

9.7 Special consideration needs to be given to the quality control requirements arising from production of biological products by continuous culture.

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