PIC/S BAB I (SISTEM MUTU FARMASI) – PENGAWASAN MUTU

BAB I (SISTEM MUTU FARMASI) – PENGAWASAN MUTU

NO VERSI ASLI VERSI TERJEMAHAN 1.9 Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, 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. The basic requirements of Quality Control are that:

(i) Adequate facilities, trained personnel and approved procedures are available for sampling and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes;

(ii) Samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by approved personnel and methods;

(iii) Test methods are validated;

(iv) Records are made, manually and/or by recording instruments, which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are fully recorded and investigated;

(v) The finished products contain active ingredients complying with the qualitative and quantitative composition of the Marketing Authorisation or Clinical Trial Authorisation, are of the purity required, and are enclosed within their proper containers and correctly labelled;

(vi) Records are made of the results of inspection and that testing of materials, intermediate, bulk, and finished products is formally assessed against specification. Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures;

(vii) No batch of product is released for sale or supply prior to certification by an Authorised Person that it is in accordance with the requirements of the relevant authorisations;…