CAPA和调查过程管理仍是MHRA现场检查关注的焦点

Managing CAPA and Investigation Processes still in the Focus of Inspectorates

CAPA和调查过程管理仍是检查关注的焦点

Deviations and CAPA remain hot topics in inspections. The inspectorates' summaries of their observations show that things do not always work as desired. Recently, the U.K. authority MHRA (Medicines and Healthcare Products Regulatory Agency) published its Top Ten Deficiency Categories. The report 'GMP Inspection Deficiencies 2013' covers 630 inspections performed in 2013. According to the report, 'deficiencies relating to 'Quality Systems' are by far the most prevalent observed during inspections'.

偏差和CAPA仍是检查的热点话题。检查缺陷总结显示这些方面的操作并不总是如期望一样有用。最近，英国药监MHRA公布了缺陷分类前十名。报告“2013GMP检查缺陷”包括了在2013年进行的630次检查。根据该份报告，“与‘质量体系’相关的缺陷到目前为止是检查中最常见的缺陷”。

The most common deficiencies during the time frame considered are listed below:

在上述时间框架内最常见缺陷列出如下：

1. Investigation of anomalies

2. Quality management

3. Investigation of anomalies - CAPA

4. Contamination, chemical/physical (or potential for)

4. Supplier and contractor audit

6. Quality management - change control

7. Documentation - procedures/PSF/TAs

7. Personnel issues - training

9. Design and maintenance of equipment

9. Documentation - manufacturing

9. Finished product testing - chemical

1. 异常调查

2. 质量管理

3. 异常调查---CAPA

4. 污染，化学/物理（或潜在）

4. 供应商和合同外包审计

6. 质量管理---变更控制

7. 文件---程序和PSF/TAs

7. 人员问题---培训

9. 设备设计和维护

9. 文件记录---生产

9. 成品检测---化学

As in the previous year, the investigation of anomalies is again at the top of the list. Observations concerning CAPA issues already follow on the third position.

与上年度一样，异常情况调查再次列在清单首位。关于CAPA的缺陷问题已经到了第三位。

What are the reasons for this? The MHRA published a set of frequently asked questions (FAQs) concerning Quality Risk Management (QRM) already in 2010. The questions and the relevant answers give a good overview and useful tips on how EU inspectorates inspect QRM elements in relation to the ICH Guidelines Q9 and Q10 and how they intend to enforce them. The British authority has emphasised particularly that all inspectorates will include QRM processes in the future, since they are required in chapter 1 of the EU-GMP Guide (Part 1). This includes the handling of complaints, the management of deviations and CAPA.

为什么会这样？MHRA在2010年就已经公布了关于质量风险管理（QRM）常见问题回答系列（FAQ）。问题和相关的回答对于EU检查组织如何检查与ICH指南Q9和Q10相关的QRM要素给出了很有用的建议，以及他们如何有意思实施这些概念。英国药监已经特意强调了所有检查会在将来包括QRM流程，因为在EU GMP指南（第一部分）第1章已经有了要求。这包括了对客诉的处理，以及对偏差和CAPA的管理。

Taking a closer view at the examples of the defect area findings it becomes obvious that root cause analysis, impact assessment and associated actions are still challenging for many companies.

如果再仔细看一下缺陷领域的例子，很明显根本原因分析、影响性评估和相关的措施对于许多公司来说，仍是一个挑战。