ProductionandProcessValidation.pptVIP

????????????????????????? ???????????????????????????????????????????????? Production and Process validation 17 January 2006 References: GMP for pharmaceutical products: main principles; WHO TRS No. 908,2003 GMP for biological products; WHO TRS No.822,1992 A WHO guide to GMP requirements, part 2:validation; WHO,1997 GMP The good practices outlined are to be considered general guides and they may be adapted to meet individual needs. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production Cross –contamination; unexpected contaminants Mix-ups; confusion (false labels) Good practices in production Principle: production operations must follow clearly defined procedures in accordance with manufacturing and marketing authorizations, with the objective of obtaining products of the requisite quality. Good practices in production:General All handling of materials and products; receipt cleaning quarantine sampling storage labelling dispensing processing packaging distribution should be done in accordance with written procedures and recorded. Good practices in production:General Any deviation from instructions or procedures should be avoid as far as possible. If deviations occur: should be done in accordance with an approved procedure approved in writing by a designated person Good practices in production:General Checks on yields and reconciliation of quantities to ensure that there are no discrepancies outside acceptable limits. Good practices in production:General Operation on different products should not be carried out simultaneously or consecutively in the same room or area unless there is no risk of mix-up or cross-contamination. Good practices in production:General At all time during processing all materials bulk containers major items of equipment rooms packaging lines being used should be labeled or identified Good practices in production:General Access to production premises should be restricted to authorized personnel. Non-