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.取樣是一個重要的操作，取樣中，每批僅有小部分被取出。如果對不具有代表性的樣品進行檢測，則不能得出有效結論。因而正確的取樣方法是質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。本附件針對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:取樣人員應接受與正確取樣操作相關的初始培訓和周期性繼續(xù)再培訓，該培訓應包括： sampling plans, 取樣計劃 written sampling procedures, 書面取樣程序 the techniques and equipment for sampling, 取樣技術和取樣工具 the risks of cross-contamination, 交叉污染風險 the precautions to be taken with regard to unstable and/or sterile substances, 對不穩(wěn)定和/或無菌物料采取的預防措施 the importance of considering the visual appearance of materials, containers and labels, 考察物料、包材和標簽的外觀的重要性 the importance of recording any unexpected or unusual circumstances. 記錄非預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完整批準的鑒別，一般需要對每個包裝進行單獨取樣，獨立檢測鑒別項。如果建立有經過驗證的程序，保證不會有單個包裝標簽錯誤情況發(fā)生，則允許對部分包裝進行取樣。3. This validation should take account of at least the following aspects: 本驗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; 生產商和供應商的具體情況和狀態(tài)，及其對制藥行業(yè)GMP要求的理解 the Quality Assurance system of the manufacturer of the starting material; 起始物料生產商的質量保證體系 the manufacturing conditions under which the starting material is produced and controlled; 起始物料的生產受到控制 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，可能需要一個驗證過的程序，以免除對以下起始物料每個進廠包裝的鑒別實驗 starting materials coming from a single product manufacturer or plant; 起始物料來自于一個僅生產一個產品的生產商或工廠 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. 起始物料從生產商處直接送來，或采用生產商的封裝容器，有歷史數(shù)據(jù)證明其可靠性，或由采購方（藥品生產商）或官方授信主體對生產商的質量保證體系進行常規(guī)審計It is improbable that a procedure could be satisfactorily validated for: 對以下情況，則不可能得到一個滿意的驗證結果 starting materials supplied by intermediaries such as brokers where the source of manufacture is unknown or not audited; 由中間商供應的起始物料，如貿易商，該物料的生產商為未知或未經審計 starting materials for use in parenteral products. 用于注射用藥生產的起始物料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行檢測，可以對起始物料的批質量進行評估。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)計學數(shù)據(jù)，并在取樣計劃中列明?？梢杂糜谥苽浠旌蠘拥膯蝹€樣品數(shù)量也應該指定，指定時應考慮物料的特性、對供應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