(1993; 36 pages)
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.