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FDA Citations and SOP's.
September 07, 2016

FDA Citation and SOP's.

When an analysis of an end user's procurement priorities is made; the importance of the equipment / programs being capable of being validated, ranks at number two out of ten; second only to delivery; with cost trailing in at sixth position. This has certainly been consistently 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 or at least available. They are normally quite willing to pay a 15 to 30 percent surcharge for these documents.

If outside consultants are 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. In my twenty years as an auditor, I can recall many instances where the validation had to be abandoned. This was usually attributable to inadequate documentation of derivation, development and certification processes for software and or materials.

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

This is why the User Requirements Specification (URS) has to be an in depth exhaustive study of all the requisite and mandated requirements, including procurement/training/servicing/calibration/facility and utility requirements. The end user has the task of initiating this study; however they should not hesitate in co-opting all the specialist advice and assistance available.

The question that is asked repeatedly:-

"Do we have to re-validate if validated equipment is moved?"

The simple answer to your question is NO. In the validation of a process; if any item/program/system can be shown to be completely innocuous to product quality or any associated predicated data; then validation is not required.

However it is required that you have a documented justification to support this rationale. This justification is predicated and therefore is a cGMP requirement and a record that an auditor will ask to view.

In risk based validation all items/systems/programs that are to be qualified, must be subjected to such assessments to ensure that the proposed intensity of validation; will be compliant with regulatory expectations.

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