(2003; 148 pages)
17. Good practices in quality control
17.1 Quality control is the part of GMP concerned with sampling, specifications and testing, and with the organization, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. Quality control is not confined to laboratory operations but must be involved in all decisions concerning the quality of the product.
17.2 The independence of quality control from production is considered fundamental.
17.3 Each manufacturer (the holder of a manufacturing authorization) should have a quality control function. The quality control function should be independent of other departments and under the authority of a person with appropriate qualifications and experience, who has one or several control laboratories at his or her disposal. Adequate resources must be available to ensure that all the quality control arrangements are effectively and reliably carried out. The basic requirements for quality control are as follows:
(a) adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting, and testing starting materials, packaging materials, and intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes;
(b) samples of starting materials, packaging materials, intermediate products, bulk products and finished products must be taken by methods and personnel approved of by the quality control department;
(c) qualification and validation must be performed;
(d) records must be made (manually and/or by recording instruments) demonstrating that all the required sampling, inspecting and testing procedures have actually been carried out and that any deviations have been fully recorded and investigated;
(e) the finished products must contain ingredients complying with the qualitative and quantitative composition of the product described in the marketing authorization; the ingredients must be of the required purity, in their proper container and correctly labelled;
(f) records must be made of the results of inspecting and testing the materials and intermediate, bulk and finished products against specifications; product assessment must include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures;
(g) no batch of product is to be released for sale or supply prior to certification by the authorized person(s) that it is in accordance with the requirements of the marketing authorization. In certain countries, by law, the batch release is a task of the authorized person from production together with the authorized person from quality control;
(h) sufficient samples of starting materials and products must be retained to permit future examination of the product if necessary; the retained product must be kept in its final pack unless the pack is exceptionally large.
17.4 Quality control as a whole will also have other duties, such as to establish, validate and implement all quality control procedures, to evaluate, maintain, and store the reference standards for substances, to ensure the correct labelling of containers of materials and products, to ensure that the stability of the active pharmaceutical ingredients and products is monitored, to participate in the investigation of complaints related to the quality of the product, and to participate in environmental monitoring. All these operations should be carried out in accordance with written procedures and, where necessary, recorded.
17.5 Assessment of finished products should embrace all relevant factors, including the production conditions, the results of in-process testing, the manufacturing (including packaging) documentation, compliance with the specification for the finished product, and an examination of the finished pack.
17.6 Quality control personnel must have access to production areas for sampling and investigation as appropriate.