|
文章来源 ICH Q7，由珐成制药系统工程（上海）有限公司 范宇 翻译 原创文章，欢迎转帖；尊重原创，从注明出处开始 1、短语“容器组合”在[ICH Q7第7.20部分和7.24部分]是否是同样含义？ 短语“容器组合”应结合每句的上下文来理解。一组容器是指多个容器由供应商采用物理方式进行保护（例如，缠绕好的托盘等），通常是为了便于运输和计数。[ICH Q7第7.20部分]中指的是对进厂物料在接收送至工厂待验之前进行目视检查。 而在[ICH Q7第7.24部分]里，“容器组合（批次）”还有另一个词“批”，因为在本部分讲的是需要对进厂物料建立批追溯性。 1. Does the phrase ‘grouping of containers’ have the same meaning in [ICH Q7, Sections 7.20 and 7.24]? The phrase ‘grouping of containers’ should be read in the context of each sentence. A grouping of containers refers to multiple containers physically secured by the supplier (e.g., shrink-wrapped pallet, etc.) usually intended for ease of shipment and reconciliation. [ICH Q7, Section 7.20] is referring to incoming visual examination of materials before acceptance into the facility under quarantine. The phrase in [ICH Q7, Section 7.24], ‘grouping of containers (batches)’ contains an additional word ‘batches’ because this section is addressing the need to establish batch traceability for the incoming material. 2、关于原料供应商的评估有什么期望？ [ICH Q7第7.11，7.12，7.31部分]使用了不同的词语来描述对原料供应商的期望，包括贸易商，如有的话。[ICH Q7第7.12部分]说所有采购的原料应符合质量标准，并从质量部门批准的供应商处采购[ICH Q7第7.31部分]。 在批准供应商之前，应基于风险对其进行评估[ICH Q9附录II.5，ICH Q7第7.31部分]。对于被列为“关键”[ICH Q7第7.11部分]的原料的供应商需要进行更为广泛的评估。 2. What is expected in terms of evaluation of suppliers of materials? Different phrases are used to describe the expectation for evaluation of suppliers of materials [ICH Q7,Sections 7.11, 7.12, 7.31], including traders, if any.[ICH Q7, Section 7.12] states that all materials are purchased against a specification and from suppliers approved by the quality unit [ICH Q7, Section 7.31]. Prior to approval of any supplier, an evaluation should be conducted using a risk-based approach [ICH Q9, Appendix II.5; ICH Q7, Section 7.31]. More extensive evaluation is needed for suppliers of those materials classified as ‘critical’ [ICH Q7, Section7.11]. 3、对原料各批进行“全检”[ICH Q7，第7.31部分]以对供应商进行确认是什么意思？ “全检”包括注册文件里载明的该原料的所有检测项目。 如果不需要注册，则全检应包括其它由原料使用者签发的正式书面质量标准里的所有分析项目[ICH Q7第7.31部分]。一个原料药应商的分析报告（COA）可能不一定与用户的质量标准相同。 3. What is meant by ‘full analysis’ [ICHQ7, Section 7.31] on batches of raw materials to qualify a supplier? A ‘full analysis’ should include all tests specified by the user of the raw material in the regulatory filing. In cases where no filing is required, the full analysis should include tests in other formal written specifications issued by the user of the raw material [ICH Q7, 7.31]. A raw material supplier’s Certificate of Analysis (CoA) may not necessarily align with the user’s specifications. 4、对供应商进行评估时是否需要进行现场审计？ 不需要。现场审计是不需要的，但是，现场审计在供应商的评估中可能是一个很有用的工具。可以对原料或供应商提供的服务进行风险评估，来建立现场审计策略，管理供应商的评估[ICH Q7第7.11，7.13部分]。 4. Are on-site audits required in the evaluation of suppliers? No. An on-site audit is not required; however, an on-site audit could be a useful tool in the evaluation of a supplier. A risk assessment of the material or the service provided can be used to develop an audit strategy and manage the ongoing evaluation of suppliers [ICH Q7, Sections 7.11, 7.31]. 5、什么样的测试可以作为鉴别检测？ 对于进厂生产物料，鉴别测试和相关方法应根据药典各论相关部分所述来使用，在批准的法规注册文件中，或在内部质量标准里（包括方法/分析程序）[ICH Q7第7.30部分]。如果可行，应考虑使用具有鉴别能力的测试用作鉴别检测。对标签或物料进行目视检查是不够的，[ICH Q7第7.32部分]所述情形除外。 5. Which tests are considered to be identity tests? For incoming production materials, identity tests and related methods should be used as described in the relevant sections of a Pharmacopoeia monograph, in an approved regulatory filing or in an in-house specification (including method/analytical procedure) [ICH Q7, Section 7.30]. When available, a discriminating test should be considered for identification testing. The visual examination of a label or the material is not considered sufficient except in the cases described in [ICH Q7, Section 7.32]. 6、是否可以延长原料的有效期或复验期？在决定可以延长多少时间时可接受的做法是什么？ 原料药生产商所用原料的生产和标识不在ICH Q7的范畴中。因此，复验期和有效期，根据ICH Q7的定义，并不严格适用于原料，原料供应商可以采用不同的方式。有效期，正如[ICH Q7第20部分]术语所定义，只适用于原料药。 原料药生产商可以基于适当的基于风险的科学论述（例如，对物料属性、检测和稳定性的了解），对[ICH Q7第7.5部分]重新评估，在超过“有效期”或“复验期”后使用一种原料。类似的论述也可以用于延长日期，这时要对物料进行重新评估。原料药生产商有责任保证原料在使用时适用于其用途。 6. Is it possible to extend the expiry date or retest date of a raw material and what is the acceptable practice to determine how long it may be extended for? Manufacturing and labelling of raw materials for use by API manufacturers is outside the scope of ICH Q7. As such, retest and expiry dates, as defined in ICH Q7, do not strictly apply to raw materials and may be used in a different manner by the raw material supplier. Expiry date, as defined in the glossary of [ICH Q7, Section 20], applies specifically to the API. API manufacturers may re-evaluate [ICH Q7, Section 7.5] and then use a raw material after the ‘expiry date’ or ‘retest date’, based on an appropriate scientific and risk-based justification (e.g., understanding of material attributes, testing, and stability). Similar justifications may be used to extend the date by which the material should be re-evaluated. It is the responsibility of the API manufacturer to ensure the raw materials are appropriate for the intended use at the time of use.
|
|
|
