GMP in blood collection and processing.
The principles of Good Manufacturing Practice have, in the main, been universally developed for the guidance of the pharmaceutical industry rather than for transfusion services. However, these rules and guides are increasingly being adapted for use in blood centres, in the production of labile blood components and of plasma for fractionation. The guide for pharmaceutical industries produced by the commission of the European Communities is used as a model here, the nine basic requirements being those applicable to Quality Management, personnel, premises and equipment, document, production, Quality Control, contract manufacture and analysis, complaints and product recall, and self-inspection. Though having more direct application to the production laboratory preparing blood components, the majority of these requirements and principles are also directly applicable to all of the activities involved in blood collection.
National Blood Service, Leeds, UK. bill.wagstaff@nbs.nhs.uk
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D001688:Biological Products / Q000302:isolation & purification / Q000592:standards; D001771:Blood Banks / Q000592:standards*; D001782:Blood Donors; D001793:Blood Preservation / Q000295:instrumentation / Q000592:standards; D001803:Blood Transfusion / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D003258:Consumer Behavior; D004345:Drug Industry / Q000592:standards; D004866:Equipment Contamination / Q000517:prevention & control; D005062:European Union; D005568:Forms and Records Control; D017408:Guidelines as Topic; D006801:Humans; D008485:Medical Audit; D011785:Quality Assurance, Health Care / Q000379:methods* / Q000592:standards; D011786:Quality Control; D012449:Safety; D000078329:Workforce; D000094902:Blood Banking / Q000379:methods
D001688:Biological Products