Validation Expectations for Sub-Contract Companies.

QUESTION

We are entering into a contract to supply machined parts to a medical device manufacturer.  Do we have to validate our machine shop?

ANSWER

You have no direct requirements from the FDA.  It is the company that uses your facilities and abilities that must ensure your company practices and procedures (with regard to the subcontract work) are compliant with all the relevant FDA and cGMP requirements and guidelines (not withstanding Utah Medical).

However it can only be highly beneficial for your company to be able to state that you operate within the requirements of 21 CFR Part 820 and indeed have been independently audited for compliance with cGMP and Part 820.  It is; at the end of the day, a good and rigorous QA and QC system.  For the busy procurement manager to find a subcontractor who is compliant is a real-time bonus.  It also greatly enhances his standing with all the QA/QC staff who are relieved of the unenviable task of trying to whip a none compliant contracting company into some degree of often reluctant compliance.  Download a copy of the Part 820 requirement here. 

So where does one start.  In your case I would start by purchasing from us a Vendor Audit document and executing against your facility.  This will give you a basic indication of what a major company is ideally looking for in selecting a subcontracting company.

The work (from here on we mean the regulated medical device work) you contract to execute on behalf of your client must be fully specified and formally documented in a format that can be reviewed by the regulatory authorities (contract / specifications / drawings / processes / tests / inspections).  Costs and or prices may be obscured or deleted as required.  No loose ends are permissible.

The Importance of Correct Procurement.

When an analysis of the end user's priorities, in procurement priorities, is made the importance of the equipment / programs being validateable ranks at number two out of ten.  Second only to delivery; with cost ranking around sixth. This has been true in over 80% of all cases we have been involved with.

For the-would-be purchaser, it gives enormous reassurance to know that regulatory compliant validation protocols and plans are supplied.  They are often willing to pay a 15 to 30 percent surcharge for these documents.  If a consultant is hired to produce the full suite of validation documents (8/9 documents) considerable costs are involved.  However it is the question; is the system / program actually capable of being validated?  That makes people hesitate.  I doubt (after over twenty years as an auditor) if there is any pharmaceutical company that has not at some time had to abandon new programs or equipment for these reasons.

The FDA have actually stated that 70% of validation problems are directly related to none compliant procurement methods.

Your comments about you having to validate the equipment or program are completely erroneous.  The end user has that task; your task is to ensure that your product is validatable.  That means in all ways it must be compliant with the applicable directives in cGMP.  On our site we carry further details of all these requirements.

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