The answer lies in a qualification audit. While a pre-qualification assessment can help identify surface deficiencies in the way a company operates, a qualification audit is a deeper dive into the background details. It is a more thorough step to ensuring that your potential new partner/client operates in a manner that prioritises patient safety and product quality by adhering to GMP/GDP guidelines. It is a risk-based approach that applies a higher level of effort and scrutiny than is possible with a pre-assessment questionnaire. The outcome of a qualification audit, in addition to helping determine if a company can meet the needs you have in a safe and compliant manner, can aid in setting the interval for re-qualification. Some elements to consider in a qualification audit include:

  1. Inherent risk associated with the company and what that means for your time and effort in auditing – for example, a sterile manufacturing facility will represent a higher level of inherent risk and will require a longer duration and potentially more than 1 auditor to thoroughly examine, while a warehousing facility or site of importation should lend itself to being thoroughly audited by a single auditor in one day.
  2. Documents and Processes – an onsite audit will often allow examination of documentation and processes that are just not possible to be examined remotely. This can be for many reasons, such as lack of video capability in cleanrooms or confidentiality issues where companies handle products for other clients.
  3. The manufacturing process – there is really no substitute for firsthand observation of manufacturing in action and there is often no other way to adequately see just how the process unfolds. This can help identify potential compliance gaps and hazards to the quality of the finished product.
  4. Personnel qualifications – while it may be possible to demonstrate that personnel have received adequate training by reviewing training records on paper, an in-person look at personnel performing their day-to-day tasks can give a much clearer picture of whether there is sufficient understanding of the job and can give visual evidence that it is performed in accordance with procedure and the relevant guidelines.
  5. Pharmaceutical Quality Systems – the PQS is the backbone of a pharmaceutical company. Onsite inspections allow an auditor access to PQS documents that may not be provided in the course of normal business between a company and client(s). For example, minor deviations may not be routinely provided but can be viewed onsite to ensure that investigations were sufficiently thorough, and that the classification of the event is appropriate.

A well-planned and thoroughly executed qualification audit requires time that may be in short supply for a busy company, and particular expertise that is acquired through years of experience in auditing. For these reasons, a qualification audit may be a daunting task for some organisations, and this is where MIAS Pharma can provide solutions. We have a wealth of knowledge and experience in-house that means we can plan and execute qualification audits to meet your needs, making it a stress-free process for you to ensure that your client or CMO operates safely and in compliance with the current regulations, guidelines, and quality standards.


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