Supplier Questionnaires and their Way into a FDA 483
供应商问卷调查及其进入 FDA 483 的方式
Questionnaires are a useful tool for obtaining information from a supplier and making initial considerations regarding audit planning. For a new supplier, questions about the nature of the quality management system provide an initial indication. The size of the company can have an influence on the duration of a possible audit and the number of auditors.
调查问卷是从供应商那里获取信息并初步考虑审计计划的有用工具。对于新供应商来说，有关质量管理体系性质的问题提供了初步迹象。公司的规模可能会影响可能的审计持续时间和审计人员的数量。
However, questionnaires are not suitable as the sole element for qualifying a supplier. And Audits are mandatory for API suppliers. A pharmaceutical manufacturer in India has now completely dispensed with auditing its API suppliers and simply sent them questionnaires. In an inspection carried out by the US Food and Drug Administration (FDA) in October, this promptly led to one observation (one of many, by the way): "The quality unit has not ensured API suppliers are appropriate for use." (...) "No onsite audit has been conducted for any supplier of APIs...". Worse still, some of the suppliers did not return the questionnaires and were used anyway. One of the suppliers was at least honest and stated that he did not carry out ICH-compliant stability tests, did not qualify the water system and did not test it regularly. He was nevertheless qualified.
然而，调查问卷并不适合用作确认一个供应商的唯一要素。对于API供应商来说，审计是强制性的。印度一家制药商完全免除了对其原料药供应商的审计，只向他们发送调查问卷。在FDA于10月份进行的一次检查中，这立即导致了一个缺陷结果（顺便说一句，这是众多缺陷结果之一）：“质量部门没有确保 API 供应商适合使用。(...)“未对任何原料药供应商进行现场审计......”。更糟糕的是，一些供应商并没有回复调查问卷，而他们仍然被使用了。其中一位供应商至少是诚实的，并表示他没有进行符合ICH标准的稳定性试验，没有对水系统进行确认，也没有定期进行监测。尽管如此，他仍然被判定为合格。
A total of 14 observations were noted in this 20-page report, with a number of deficiencies, e.g:
在这份20页的报告中，共注意到14项观察项，其中有一些缺陷，例如：
No adequate procedure to prevent microbial contamination during manufacturing and cleaning processes
在生产和清洁过程中没有适当的程序来防止微生物污染
Inadequate laboratory controls, records and reports. The same for manufacturing documentation
实验室控制、记录和报告不足。生产记录也是如此
Inadequate smoke studies and media fills
烟雾试验和培养基灌装缺陷
Buildings in poor condition
厂房状况不佳
No identity testing for incoming APIs
未对入厂API进行鉴定
Insufficient stability testing
稳定性试验缺陷
Etc.
等
Incidentally, the plant was then issued with an "Import Alert" on 23 October 2023, three days after the483 was issued on 20 October 2023.
该工厂随后于 2023 年 10 月 23 日被发出“进口警报”，即 2023 年 10 月 20 日发布 483 的三天后。
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