EU-GMP-指南附件8：起始物料和包裝材料的取樣(中英文)

EU GMP 指南附件8：起始物料和包裝材料的取樣（中英文）EU GMP 指南附件8：起始物料和包裝材料的取樣（中英文） Annex 8 附件8SAMPLING OF STARTING AND PACKAGING MATERIALS起始物料和包裝材料的取樣Principle 原則Sampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the whole cannot be based on tests which have been carried out on nonrepresentative samples. Correct sampling is thus an essential part of a system of Quality Assurance.取樣是一個(gè)重要的操作，取樣中，每批僅有小部分被取出。如果對(duì)不具有代表性的樣品進(jìn)行檢測(cè)，則不能得出有效結(jié)論。因而正確的取樣方法是質(zhì)量保證體系的必要因素。Note 注Sampling is dealt with in Chapter 6 of the Guide, items 6.11. to 6.14. This annex gives additional guidance on the sampling of starting and packaging materials.取樣在指南第6章第6.11至6.14項(xiàng)。本附件針對(duì)起始物料和包裝物料給出一些額外的指南。Personnel 人員1. Personnel who take samples should receive initial and on-going regular training in the disciplines relevant to correct sampling. This training should include:取樣人員應(yīng)接受與正確取樣操作相關(guān)的初始培訓(xùn)和周期性繼續(xù)再培訓(xùn)，該培訓(xùn)應(yīng)包括： sampling plans, 取樣計(jì)劃 written sampling procedures, 書面取樣程序 the techniques and equipment for sampling, 取樣技術(shù)和取樣工具 the risks of cross-contamination, 交叉污染風(fēng)險(xiǎn) the precautions to be taken with regard to unstable and/or sterile substances, 對(duì)不穩(wěn)定和/或無菌物料采取的預(yù)防措施 the importance of considering the visual appearance of materials, containers and labels, 考察物料、包材和標(biāo)簽的外觀的重要性 the importance of recording any unexpected or unusual circumstances. 記錄非預(yù)期或異常情況的重要性Starting materials 起始物料2. The identity of a complete batch of starting materials can normally only be ensured if individual samples are taken from all the containers and an identity test performed on each sample. It is permissible to sample only a proportion of the containers where a validated procedure has been established to ensure that no single container of starting material has been incorrectly labelled. 為保證起始物料一個(gè)完整批準(zhǔn)的鑒別，一般需要對(duì)每個(gè)包裝進(jìn)行單獨(dú)取樣，獨(dú)立檢測(cè)鑒別項(xiàng)。如果建立有經(jīng)過驗(yàn)證的程序，保證不會(huì)有單個(gè)包裝標(biāo)簽錯(cuò)誤情況發(fā)生，則允許對(duì)部分包裝進(jìn)行取樣。3. This validation should take account of at least the following aspects: 本驗(yàn)證需要考慮至少以下方面 the nature and status of the manufacturer and of the supplier and their understanding of the GMP requirements of the Pharmaceutical Industry; 生產(chǎn)商和供應(yīng)商的具體情況和狀態(tài)，及其對(duì)制藥行業(yè)GMP要求的理解 the Quality Assurance system of the manufacturer of the starting material; 起始物料生產(chǎn)商的質(zhì)量保證體系 the manufacturing conditions under which the starting material is produced and controlled; 起始物料的生產(chǎn)受到控制 the nature of the starting material and the medicinal products in which it will be used. 起始物料的屬性和使用該起始物料的藥品的屬性Under such a system, it is possible that a validated procedure exempting identity testing of each incoming container of starting material could be accepted for: 在這種體系下，可能需要一個(gè)驗(yàn)證過的程序，以免除對(duì)以下起始物料每個(gè)進(jìn)廠包裝的鑒別實(shí)驗(yàn) starting materials coming from a single product manufacturer or plant; 起始物料來自于一個(gè)僅生產(chǎn)一個(gè)產(chǎn)品的生產(chǎn)商或工廠 starting materials coming directly from a manufacturer or in the manufacturers sealed container where there is a history of reliability and regular audits of the manufacturers Quality Assurance system are conducted by the purchaser (the manufacturer of the medicinal product) or by an officially accredited body. 起始物料從生產(chǎn)商處直接送來，或采用生產(chǎn)商的封裝容器，有歷史數(shù)據(jù)證明其可靠性，或由采購方（藥品生產(chǎn)商）或官方授信主體對(duì)生產(chǎn)商的質(zhì)量保證體系進(jìn)行常規(guī)審計(jì)It is improbable that a procedure could be satisfactorily validated for: 對(duì)以下情況，則不可能得到一個(gè)滿意的驗(yàn)證結(jié)果 starting materials supplied by intermediaries such as brokers where the source of manufacture is unknown or not audited; 由中間商供應(yīng)的起始物料，如貿(mào)易商，該物料的生產(chǎn)商為未知或未經(jīng)審計(jì) starting materials for use in parenteral products. 用于注射用藥生產(chǎn)的起始物料4. The quality of a batch of starting materials may be assessed by taking and testing a representative sample. The samples taken for identity testing could be used for this purpose. The number of samples taken for the preparation of a representative sample should be determined statistically and specified in a sampling plan. The number of individual samples which may be blended to form a composite sample should also be defined, taking into account the nature of the material, knowledge of the supplier and the homogeneity of the composite sample. 通過采取具有代表性的樣品進(jìn)行檢測(cè)，可以對(duì)起始物料的批質(zhì)量進(jìn)行評(píng)估。鑒別用樣品可以用于此目的。用于具有代表性的樣品制備的樣品數(shù)量可以基于統(tǒng)計(jì)學(xué)數(shù)據(jù)，并在取樣計(jì)劃中列明?？梢杂糜谥苽浠旌蠘拥膯蝹€(gè)樣品數(shù)量也應(yīng)該指定，指定時(shí)應(yīng)考慮物料的特性、對(duì)供應(yīng)商的了解和混合樣的均一性。Packaging material 包裝材料5. The sampling plan for packaging materials should take account of at least the following: the quantity received, the quality required, the nature of the material (e.g. primary packaging materials and/or printed packaging materials), the production methods, and what is known of the Quality Assurance system of the packaging materials manuf