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Supplier Vs Regulatory Audits

Recently we have been asked to perform several gap analyses exercises for supply chain organisations that are hoping to win business with pharmaceutical clients.  There has been a mismatch in what WE, have been asked to do, so I thought that writing this short and to-the-point article would be useful.

Regulatory

Firstly, in this context a regulatory audit is one that will be performed by the MHRA/FDA or other national body on the application of legislative requirements within a pharmaceutical company.  For example for the application of GMPs.  It is usually the case whereby the regualtory body will inform the company of their intented visit and then arrive to site and conduct their audit in accordance with their predefined requirements.

Do they only look at what they originally said?  No, they don’t – it is not uncommon for them to have a look at something that is brought to their attention or at something of interest within their peripheral vision, for example when inspecting a change log, they might ask to see an additional change control that is of interest to them, or another item or items that are referenced from the change log.  In order to prevent citation, or at least minimise it, make sure that your controls are robust.  Make sure the quality system is being used properly, and the procedures are current and that they work!  If you aren’t sure, get help!

Supplier

Supplier audits are carried out by companies to ensure that they can supply a consistently fit-for-purpose product/service at all times.  The crux of these supplier audits is basically an assessment of the suppliers’ quality systems; for example if you are going to buy in a control system, it is obviously an intented long-term investment, that being the case there will be an ongoing level of support required from the vendor, and likewise this is going to yield a support agreement between the two companies whereby the supplier is making money from the pharmaceutical company and the pharmaceutical company is making money from the control system.

The pharmaceutical company has to be sure that when they are receiving products (upgrades, updates, changes, hotfixes and all of that stuff) from the vendor (supplier) that they have adequately controlled the release of that product.  This can be determined by performing an audit of the suppliers quality system.  For example, if the supplier has a set of perfect procedures encompassing change / configuration and release management, and a bells-and-whistles document management system, they should be fine.  But on inspection, if there has never been a change entered into the change log for 6 months after the procedure’s effective date – this raises questions about whether they do, truly have a full and complete understanding of their own systems, because one thing is for sure, things change and if they don’t have documented changes then their documentation can’t reflect the system.  How might that affect your control system?

Summary

Regulatory audits are performed by legislators, supplier audits are performed by potential clients.  The client needs peace of mind that you’re going to do everything in your power to control and regulate your products and services in order for them to be able to produce fit-for-purpose, consistent products themselves.  If your potential client finds that everything is too perfect and no mistakes have been made -ever, then they’ll probably suspect some sort of mistake; everyone makes them!  The outcome of the supplier audit is whether or not you win the work.

Regualtory audits are verifiying conformance to the governing legistation.  If they observe any serious non-conformances they have the power to have you shut-down (not that this happens very often, but nevertheless they have the power) or stop you from trading.  So it pays to comply.  If in doubt.  Seek professional assistance.

Suggested Additional Reading

Benefits of Proceduralised Systems
An Easy Way to Validate an SQL Report
The Power of Word Processing and Typing Skills

Author:

Mark Richardson
Director of Operations
Kestrel Life Sciences
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One Response to Supplier Vs Regulatory Audits

  1. Reinaldo says:

    Like the fresh design. I really liked this content. Thanks a lot for this cool blog.


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