【文章內(nèi)容簡介】 ...........49Sampling................................... .............................................................................................50Testing... ................................................................................................................................52銷售產(chǎn)品的穩(wěn)定性考察.................................................................................................54第七章 委托生產(chǎn)與委托檢驗(yàn)CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS......................................55 原則........................................ ..............................................................................................55Principle................................... ..............................................................................................55 通則........................................ ..............................................................................................56General..................................... ..............................................................................................56委托方.................................... ..............................................................................................56The Contract Giver.................... ............................................................................................56 受托方.................................... .............................................................................................57The Contract Acceptor.............. .............................................................................................57合同........................................ ..............................................................................................58The Contract............................. .............................................................................................58第八章 投訴與召回CHAPTER 8: COMPLAINTS AND PRODUCT RECALL..................................................59原則........................................ ..............................................................................................59Principle.................................... ..............................................................................................59投訴........................................ ..............................................................................................59Complaints................................ ..............................................................................................59召回........................................................................................................................................60Recalls......................................................................................................................................60第九章自查CHAPTER 9: SELF INSPECTION........................................................................................61原則.......................................................................................................................................61Principle..................................................................................................................................61附件8 原輔料和包裝材料的取樣ANNEX8 SAMPLING OF STARTING AND PACKAGING MATERIALS.......................63原則.......................................................................................................................................63Principle..................................................................................................................................63人員.......................................................................................................................................63Personnel.................................................................................................................................63原輔料...................................................................................................................................63Starting materials.....................................................................................................................64包裝材料...............................................................................................................................65Packaging material...................................................................................................................65第一章 質(zhì)量管理CHAPTER 1 QUALITY MANAGEMENTPrinciple原則生產(chǎn)許可證持有廠家只能生產(chǎn)醫(yī)藥產(chǎn)品，以確保藥品符合其預(yù)期的使用目的，符合銷售許可證的要求，并不因藥品安全性、質(zhì)量或藥效方面的問題而給患者帶來風(fēng)險。達(dá)到這一質(zhì)量目標(biāo)是高層管理者的責(zé)任，同時也需要公司各部門、各層次的職員以及公司的供應(yīng)商和銷售商的參與并承擔(dān)義務(wù)。為了確保達(dá)到該質(zhì)量目標(biāo)，必須全面設(shè)計并正確貫徹實(shí)施包括GMP與質(zhì)量控制(QC)在內(nèi)的質(zhì)量保證(QA)體系。該體系應(yīng)用文件明文規(guī)定并對其有效性加以監(jiān)控。質(zhì)量保證體系的所有部門都必須充分配備勝任的人員，適宜足夠的廠房、設(shè)備及設(shè)施。與此同時，生產(chǎn)許可證持有者及受權(quán)人員具有另外的法律責(zé)任。The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, ply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and mitment by staff in many different departments and at all levels within the pany, by the pany’s suppliers and by the distributors. To achieve the quality objective reliably there must be a prehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice and thus Quality Control. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance system should be adequately resourced with petent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s).、GMP和質(zhì)量控制的基本概念是內(nèi)在相互聯(lián)系的。這里敘述的主要目的是強(qiáng)調(diào)它們之間的關(guān)系以及藥品生產(chǎn)和控制中的重要性。 basic concepts of Quality Assur