Auditing can be one of the more challenging aspects of managing relationships with contract manufacturing organisations/contract laboratories (CMO/CLO), but as with many processes, thorough preparation can be the key to success. Points to consider when preparing for an audit include deciding whether the audit will be remote or onsite, scheduling of the audit date(s), creation of an audit agenda, identification of any pre-audit documentation requirements, and selection of appropriate auditors. For audits to EMA standards, having an awareness of the specific requirements imposed is also of benefit.

Remote or Onsite Audit?

Allowing an auditor to observe a process firsthand, at the site where operations are performed is often the best way to ensure that an audit gives an accurate picture of an organisation’s compliance. It allows observation of the personnel performing operations and provides insight that may not be possible remotely. However, due to constraints imposed by time zone differences, geographic locations, travel costs, and legal provisions in quality agreements, a remote audit may be an effective way to generate an equally appropriate overview. Remote audits can be conducted live, at a mutually agreed time or as a desk top exercise where real-time collaboration between auditor and auditee is not required.

Scheduling an Audit

An audit is both a snapshot in time of a particular process and an opportunity to scrutinize longer-term performance and may require a significant investment in time and personnel from both the auditing body and the site being inspected. Communication between parties is paramount when it comes to finding a date and time that is suitable for both. Ideally this should be a date/time when the process being audited is in operation so that effective observation of the real-time process can be achieved. Care should be taken to schedule audits at times when appropriate resources at the audited site can be dedicated to the audit.

Creating an Audit Agenda

A well-thought-out agenda is absolutely critical to a successful audit. Time constraints are often a limiting factor and there is more often than not a significant amount of information to get through on the day. A typical audit agenda for an onsite audit may include but is not limited to elements such as:

  • Opening presentations by the auditees (Company structure and background)
  • Site tours (Manufacturing, Laboratories, Warehousing Facilities)
  • Review of previous audit observations, including Regulatory history
  • Interviews with SMEs for various functions
  • Review of training programmes
  • Documentation reviews (Deviation/CAPA, Change Controls, Complaints, etc.)

While the agenda can help manage audit time, care should be taken to build in some flexibility so that the various elements can be shifted around to accommodate changes in the availability of personnel and process at the auditee’s site.

 

 

Pre-audit Documentation Review

Given the relatively brief time that most auditors have during the actual audit, review of some documentation in advance can help the auditor maximise their effectiveness while conducting the audit. Some documentation will be of a confidential nature and may only be available to view while onsite or engaged in a remote live audit, so it pays for auditors to review as many documents as possible beforehand, saving the time for those critical confidential documents while performing the inspection.  Commonly requested documents that could be reviewed in advance of the inspection include:

  • Site Master File(s)
  • Lists of quality events (deviations, change controls, complaints, lab investigations)
    • Events referencing only products for which the auditor is inspecting may be provided in advance, but events referencing products outside the audit scope may only be available onsite.
  • List of site SOPs
  • Training programme details
  • Regulatory audit reports (if closed and public domain)
  • Regulatory Licenses
  • Master and executed batch manufacturing/packaging records.
  • Validation/Qualification studies

Selection of Auditors

Finding the right person to make the most of the limited time available for auditing can be one of the greatest challenges in planning an audit. The ideal candidate would have previous experience with the systems and processes involved, and a proven track record of inspecting to the quality standards of the various regulatory bodies.  The inspecting site may not always have such qualified personnel, or may be constrained by resources such as time and budget, or may not be aware of the nuances of complying with EMA standards and this is where MIAS Pharma can help you to ensure that your contract organisations are operating to the high quality standards expected.

MIAS has a wealth of experience across the industry, both in-house and via our wide network of associates. We can audit for relatively straightforward processes such as solid oral dose manufacture, all the way to the more complex and intricate processes for sterile production and manufacture of gene and cell therapies. MIAS can perform audits on your behalf or can review audits performed for you by other inspectors or can offer gap assessments in advance of regulatory inspections that will allow you to make improvements to proactively avoid observations so that your audit experience is smooth, efficient and successful.

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