TRS 1060-附件4：血液机构良好做法

Good practices for blood establishments Replacement of Annex 4 of WHO Technical Report Series, No. 961 Contents Abbreviations180 Introduction181 Purpose and scope183 Terminology184 1.Quality management 189 1.1General principles1891.2Quality system1891.3Good practice1921.4Quality risk management1941.5Change control1951.6Deviations1961.7Complaints1971.8Recall1971.9Corrective and preventive actions1981.10Self-inspection, audits and improvements200 2.Personnel2.1General principles2.2Personnel 3.Premises 202 3.1General principles3.2Blood donor area3.3Blood collection area3.4Blood testing and processing areas3.5Storage area3.6Ancillary areas3.7Waste disposal area 4.Equipment and materials206 4.1General principles4.2Data processing systems4.3Qualification and validation 206208211 4.4Process validation2164.5Validation of test methods2204.6Control of equipment and materials220 5.Documentation 5.1General principles2225.2Required good practice documentation (by type)2235.3Generation and control of documentation2245.4Good documentation practices2255.5Retention of documents2255.6Specifications2265.7Preparation instructions2275.8Preparation records2275.9Procedures and records2285.10Sampling2295.11Other229 6.Blood collection, testing and processing230 6.1Donor eligibility2306.2Collection of blood and blood components2326.3Laboratory testing2346.4Screening for infectious agents2356.5Blood group serological testing of donors and donations2366.6Processing2376.7Labelling2386.8Release of blood and blood components2396.9Quality monitoring and control240 7.Storage and distribution 241 7.1General principles7.2Verification of transportation7.3Return of blood and blood components 241242242 8.Outsourced activity management 8.1General principles8.2The contract giver8.3The contract acceptor8.4The contract 243243244244 Authors and acknowledgments 245 References AppendixFurther information on the interpretation and implementation ofgood practices 247 Guidance documents published by the World Health Organization(WHO) are intended to be scientific and advisory in nature. Eachof the following sections provides guidance to blood establishmentmanagers and staff on ensuring the quality, safety and efficacy ofblood and blood components for transfusion and plasma for furtherindustrial fractionation. The good practices described in each sectionof this document could also be used as the basis of inspections by thenational regulatory authority (NRA) and may, if an NRA so desires,be adopted as definitive national requirements, or modificationsmay be justified and made by the NRA. It is recommended that suchmodifications are made only on condition that such modificationsensure that blood and blood components are at least as safe andefficacious as those prepared in accordance with the good practicesand associated further guidance provided below. Abbreviations WHO Technical Report Series, No. 1060, 2025CAPAcorrective and preventive actionCPPcritical process parameterCQAcritical quality attributeDQdesign qualificationEDQMEuropean Directorate for the Quality of Medicines &HealthCareEUEuropean UnionFATfactory acceptance testFMECAfailure mode, effects and criticality analysisFTAfault tree analysisFMEAfailure mode effects analysisGMPgood manufacturing practice(s)GPG(EU/EDQM) Good Practice GuidelinesHACCPhazard analysis and critical control pointsHBVhepatitis B virusHAZOPhazard operability (analysis)HCVhepatitis C virusHIVhuman immunodeficiency virusIQinstallation qualificationNATnucleic acid amplification techniqueNRAnational regulatory authorityOQoperational qualificationPIC/SPharmaceutical Inspection Co-operation SchemePHApreliminary hazard analysisPQperformance qualificationRBCred blood cellRhDrhesus DSATsite acceptance testing SOPstandard operating procedureTRALItransfusion-related acute lung injuryURSuser requirements specificationVMPvalidation master plan Introduction The WHO Requirements for the collection, processing and quality control ofblood, blood components and plasma derivatives (1) define a quality assurancesystem based on: (a) the existence of a national structure that is independent ofmanufacturers; (b) compliance with the process of quality assurance for biologicalproducts – that is, control of starting material(s), production processes and finalproduct(s); and (c) strict adherence to the principles of good manufacturingpractices (GMP). The importance of establishing reliable quality assurancesystems for the whole chain of blood collection, processing and distribution ofblood components in blood establishments was also emphasized by the Sixty-third World Health Assembly in resolution WHA63.12 on the availability, safetyand quality of blood products (2). In that resolution, quality assurance was seenas a necessary measure that would contribute to the increased global availabilityof blood (including plasma) and blood products that meet internationallyrecognized standards. Resolution WHA63.12 further re