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

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


BioPharm International Supplements


Conducting an Audit

It is essential that before the audit, a lead auditor is chosen, who will be responsible for organizing the audit and collating the observations raised. Also, the lead auditor usually is the most appropriate person to be the primary author of the audit report.

The Introductory Meeting

An introductory meeting is an essential and useful part of the audit because it gives the audit team an overview of the company and facility that are being audited. This meeting will set the tone of the audit, so it is essential that this meeting be given its due importance and not be seen as something to be endured before the "real" audit. There is often important and useful information to be gleaned from this initial meeting of the respective parties.

The Facility Tour

During the facility tour, the audit team can get an early impression of the strengths and weaknesses of the company's procedures and its commitment to quality. It is critical that the audit team listen carefully to what the staff ask and have to say, and also to take the time to observe the condition and status of rooms and equipment, as this is often an indicator of the status of the relevant systems in place at the facility.

The facility tour is sets the scene for the rest of the audit and its value should not be underestimated.

Conducting the Audit

As mentioned earlier, the audit team should comprise members with complementing areas of expertise, and following the facility tour, they may split their focus to match their areas of expertise as well as to follow up on any observations identified during the tour.

It is the responsibility of the lead auditor to manage the audit so that where possible, the majority, if not all, of the critical items on the audit agenda are covered. However, if a critical or significant observation is noted, this should be followed up, even if it is to the detriment of completing an inspection of all items on the original agenda.

It is inevitable that most auditors will at some point in their career find that their observations place them in a position of conflict with an auditee. These situations must be managed carefully, and it is important for the auditor to take into consideration any regional (e.g., EU versus US) differences in expectations, as well as the company policies of the auditee. It is always beneficial to resolve any conflict by discussion. The use of factual examples for demonstrating an auditor's points of view are often key to defusing any potential conflict.

Another key point is to ensure that every observation is clearly raised during the audit. This allows the auditee time to investigate the issue and provide additional data, and may mitigate the impact of the observation or in many instances close out the issue before the audit is complete.

Close-out Meeting

Before the final close-out meeting, the auditing team should meet in private and agree on the following content of the feedback:

  • the categorization of the observations; normally based on guidelines from the EMEA, MHRA, or FDA, as well as internal company policy;
  • the content of the observations; these should all have been communicated to the auditees during the audit;
  • the format for the feedback; the lead auditor or each individual auditor may provide feedback on the observations they raised during the audit.

It is recommended that the close-out meeting begin with any positive observations noted during the conduct of the audit. All observations should be clearly expressed and the response of the host taken into consideration. This is essential because the close-out meeting will often include senior members of the CMO who have not been involved in the actual audit process.

This also is the time to be clear about expected timelines for responses related to any critical observations and the complete response to the audit report once it has been received by the CMO.


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