欢迎您注册蒲公英
您需要 登录 才可以下载或查看，没有帐号？立即注册
x
本帖最后由 luckylala 于 2022-5-14 23:26 编辑
PDA在2021年11月17日发布了关于CCS污染控制策略的Q&A，共计24个问答，本次连载基于这些问答进行翻译及研讨观点总结，由IPPM联合PharmLink共同推出。
Background：
Annex 1 requires designing an effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles. In the “Contamination Control Strategies: Disinfectant Programs Support to Contamination Control” session, held Oct 4 during the 2021 PDA Pharmaceutical Microbiology Conference, presenters discussed designing an effective CCS in an aseptic cleanroom environment and moving toward compliance with proposed Annex 1 regulatory requirements for facility assessment.
附录1要求根据科学评估设计有效的污染控制策略 (CCS)，以了解流程、并应用风险管理原则。2021年10月04日PDA药物微生物学会议期间，举行了“污染控制策略：消毒剂计划支持污染控制”会议，其中演讲者讨论了在无菌洁净室环境中设计有效的CCS，并在附录1（草案）设施评估的法规要求符合性上迈进。
In the Q&A session that followed, twenty minutes proved an insufficient amount of time to address the many questions posted on the “Ask A Question” board. Consequently, the three panelists—Rafael Beaus, PhD, Global Consultancy Manager, Azbil Telstar; James N. Polarine, Jr., Senior Technical Service Manager, STERIS Corporation; and Benoit Ramond, PhD, Head of Microbiology & Sterile Technology, Sanofi—collaborated to provide answers for those questions that remained.
在随后的问答环节中，20分钟证明时间不足以解决“提问”板上的许多问题。因此，以下三位小组成员紧密合作交流，为那些仍然存疑的问题提供了如下的答案。
Rafael Beaus博士，Azbil Telstar 全球咨询经理
James N. Polarine, Jr.，STERIS Corporation 高级技术服务经理
Benoit Ramond博士，赛诺菲微生物学和无菌技术主管
Q1：We see that Annex 1 suggests doing things in a certain way, but it is not forcing us to do it. Can we continue doing things the same way?
我们看到附录1建议以某种方式做事，但它并没有强迫我们去做。我们可以继续以过去同样的方式做事吗？
A1：You will see that all regulations suggest doing things, but this is a polite way of telling you how to do things. Not following these suggestions may mean getting into trouble in front of an inspection, as inspectors will expect you to follow those standards unless you can justify very well that there is a production process difficulty complying with any of them. I would not suggest continuing to do things the same way once [Annex 1] comes into force.
你会看到所有的法规都说建议如何去做，但这是告诉你如何做事的方式。不遵循这些建议可能意味着在检查时遇到麻烦，因为检查员会希望你遵循这些标准，除非你能很好地证明生产过程在遵循这些标准上困难。一旦附录1生效，我不建议继续以过去同样的方式做事。
Q2：What is the expected publication date for the new Annex 1 version? Is any delayed implementation expected (>6 months from publication)?
新附录1的预计正式发布日期是什么时候？是否预计会延迟实施（从发布起6个月以上）？
A2：The publication date was expected to be some months ago, but the current situation led to delaying it several times. There isn’t anything confirmed, but it is expected by the end of the year or the beginning of next year, even though a new delay shouldn’t be a surprise. According to previous experience with new versions of regulations, there is always some time left for companies to comply with it, usually around one year. Nevertheless, as mentioned in the Q&A session, new facilities will be requested to comply right from the beginning, while some very old facilities, where updating may be impossible, will be pushed to use a CMO to make their production.
几个月前就应该已经发布了，然而目前的现状导致它多次推迟。目前没有任何确定的信息，但预计在今年年底或明年年初发布，不过再次推迟应该也不是一个意料之外的事情。根据以往新版法规的经验，会有一定的时间让企业来实现合规，这通常在一年左右。尽管如此，正如在问答环节中提到的，新场地将被要求从一开始就遵守；而对于一些可能无法更新的非常旧的设施场地，将被迫使用CMO（外包生产）进行生产。
Q3：Will there be a time frame for the implementation of the new Annex 1, as soon as it becomes effective, for the companies to comply?
新附录1生效后，是否有一个时间框架供公司遵守？
A3：There is not a common rule, but we may expect around one year’s time to catch up or, at least, to develop a plan for catching up.
没有通用规则，但我们可能预计大约需要一年的时间才能实现合规，或者至少来制定一个合规实施计划。
注：以上三个问答为PDA Letter中的问答翻译而成，未加入其他观点。
翻译：PharmLink 许华平（Paul） 内容校对及编辑：IPPM 杨清
| 
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2021-12-28 17:54:15
置顶卡
变色卡
楼主
发表于 2022-8-2 13:10:15