Effective Auditing of CMOs - It is important that all stages of the audit be given an equal measure of attention. - BioPharm International


Effective Auditing of CMOs
It is important that all stages of the audit be given an equal measure of attention.

BioPharm International Supplements

The Audit Report

Most organizations have internal standards that state the timelines for the delivery of audit report. Every effort should be made to write and approve the report within 10 working days of audit completion.

The report should be structured and written clear and unambiguous language. Typically, the report should include an introduction, summary, observations, and conclusion.

The introduction should include reference to the standards audited against and a brief description of the facility being audited, as well as the audit team's composition and a copy of reference to the audit agenda (this may be added as an appendix). In this section, it would be appropriate to include definitions of the categorizations used for the audit findings because these may differ from organization to organization. This section also should include a list of the individuals interviewed or involved in the audit.

The summary should be a high-level summary of the audit findings (e.g., number and categorization of observations) and should also list or refer to the documentation reviewed during the audit.

The observations section should be well structured and concise. It can be structured by classification of observation or by area or quality system component (e.g., documentation, facilities, etc.). It also is common to include recommendations for actions to be taken in response to observations. However, doing so is neither necessary nor, in all cases, appropriate.

The conclusion section should clearly state the timeline requirements for responses and the conclusions of the auditors with reference to the purpose of the audit.

Responses and Follow-Up

Responses and follow-up to an audit are often inadequate because once responses are received, little follow-up is done by the auditing organization and the main follows up often takes place at the next scheduled audit. This is not a best practice and does not deliver the value to the auditing company that an effective and well-managed audit should.

The lead auditor should be in regular contact with the auditee to ensure receipt of responses according to established timelines. In some cases, the final audit report is not issued by the audit team until adequate responses have been received. This may be when the auditing process feeds into the CAPA system of the CMO, and can be a useful tool for the audit team when tracking the close-out of observations.

When assessing the adequacy of responses (including proposed timelines), several factors should be taken into account, including the category of observation, the complexity of CAPAs required, and the number of observations requiring actions.


Effective auditing depends on a number of factors including clear identification of the purpose of the audit, comprehensive audit preparation, the composition of the audit team, clarity of reporting and monitoring of observations, and an assessment of responses and follow-up to the audit.

D. Howe is a QA validation manager at Renovo, Manchester, UK, +44 (0)161 276 7100,
and L. Winberry, PhD, is a senior consultant at Biologics Consulting Group.

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