17. Good Practices In Quality Control
17.1 QC is the part of GMP concerned with sampling, specifications and testing, and with the organization and documentation 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 compliant with the requirements. QC is not confined to laboratory operations, but may be involved in many decisions concerning the quality of the product.
17.2 The independence of QC from production is considered fundamental.
17.3 Each manufacturer should have a QC function. The QC function should be independent of other departments and under the authority of a person with appropriate qualifications and experience. Adequate resources must be available to ensure that all the QC arrangements are effectively and reliably carried out. The basic requirements for QC 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 by the QC department;
(c) Qualification and validation;
(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) 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 for the appropriate time in its final pack unless the pack is exceptionally large, in which case one that is equivalent to the marketed packaging system may be used.
17.4 Other QC responsibilities include:
(a) Establishing, validating and implementing all QC procedures;
(b) Evaluating, maintaining and storing reference standards for substances;
(c) Ensuring the correct labelling of containers of materials and products;
(d) Ensuring that the stability of the active pharmaceutical ingredients and products is monitored;
(e) Participating in the investigation of complaints related to the quality of the product;
(f) Participating in environmental monitoring;
(g) Participation in QRM programmes.
These activities should be carried out in accordance with written procedures and, where necessary, recorded.
17.5 QC personnel must have access to production areas for sampling and investigation as appropriate.
Control Of Starting Materials and Intermediate, Bulk and Finished Products:
17.6 All tests should follow the instructions given in the relevant written test procedure for each material or product. The result should be checked by the supervisor before the material or product is released or rejected.
17.7 Samples should be representative of the batches of material from which they are taken in accordance with the approved written procedure.
17.8 Sampling should be carried out so as to avoid contamination or other adverse effects on quality. The containers that have been sampled should be marked accordingly and carefully resealed after sampling.
17.9 Care should be taken during sampling to guard against contamination or mix up of, or by, the material being sampled. All sampling equipment that comes into contact with the material should be clean. Some particularly hazardous or potent materials may require special precautions.
17.10 Sampling equipment should be cleaned and, if necessary, sterilized before and after each use and stored separately from other laboratory equipment.
17.11 Each sample container should bear a label indicating:
(a) The name of the sampled material;
(b) The batch or lot number;
(c) The number of the container from which the sample has been taken;
(d) The number of the sample;
(e) The signature of the person who has taken the sample;
(f) The date of sampling.
17.12 Out-of-specification results obtained during testing of materials or products should be investigated in accordance with an approved procedure. Records should be maintained.
WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles
(Annex 2, WHO Technical Report Series 986, 2014)
