Division of Industrial Pharmacy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
Drug Dev Ind Pharm. 2010 Jun;36(6):632-7. doi: 10.3109/03639040903406134.
Use of external contractors is nowadays inevitable in the pharmaceutical industry. Therefore the amount of current good manufacturing practice audits has been increasing. During the audit, a large amount of items should be covered in a limited amount of time. Consequently, pharmaceutical companies should have systematic and effective ways to manage and prepare for the audits. This study is a continuation to the earlier study, where a tool for the preparation of cGMP audit was developed and its content was validated. The objective of this study was to evaluate the usefulness of the developed tool in audit preparation and during the actual cGMP audit.
Three qualitative research methods were used in this study (observation, interviews, and opinion survey). First, the validity of the information given through the tool was examined by comparing the responses to the actual conditions observed during the contract manufacturer audits (n = 15). Additionally the opinions of the contract manufacturers of the tool were gathered (n = 10) and the auditors were interviewed (n = 2).
The developed tool was proven to be useful in audit preparation phase from both the auditor's and the contract manufacturers' point of view. Furthermore, using the tool can also save some time when performing the audit.
The results show that using the tool can give significant support in audit preparation phase and also during the actual audit.
如今，在制药行业使用外部承包商是不可避免的。因此，现行良好生产规范审核的数量一直在增加。在审核过程中，需要在有限的时间内涵盖大量项目。因此，制药公司应该有系统和有效的方法来管理和准备审核。本研究是早期研究的延续，其中开发了一种用于准备 cGMP 审核的工具，并验证了其内容。本研究的目的是评估开发的工具在审核准备和实际 cGMP 审核期间的有用性。
本研究采用了三种定性研究方法（观察、访谈和意见调查）。首先，通过将工具中提供的信息与合同制造商审核期间观察到的实际情况进行比较（n = 15），检查了信息的有效性。此外，还收集了合同制造商对该工具的意见（n = 10）并采访了审核员（n = 2）。
从审核员和合同制造商的角度来看，开发的工具在审核准备阶段非常有用。此外，使用该工具还可以在进行审核时节省一些时间。
结果表明，使用该工具可以在审核准备阶段和实际审核期间提供重要支持。
