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Validation Document Packages. August 21, 2013 |
Validation Packages an introduction. During a regulatory visit the inspectors do expect to see a complete suite of validation documents in place for each validation task. The use and scope of the individual documents has been documented, discussed and explained in detail. It is therefore obviously best policy to have in place exactly what the regulator is looking for. This is the reason why eight years ago; when we ran a questionnaire on our site, two requirements stood head and shoulders above all else; 1. Complete Documentation Packages. 2. A combined IQ/OQ/PQ Protocol for laboratory instruments. The use of a document packages ensures a multitude of regulatory requirements are catered for and possibly a similar multitude of pitfalls, blunders and omissions are anticipated and negated. After due diligence is used to review the current Good Manufacturing Practice (cGMP) legislation (21 CFR Part 11/210/211/820) along with the FDA guidance documents (not mandatory but probably advisable) it becomes rather obvious why there is cascade of documentation and why each document in this cascade is obligatory. At this stage it becomes patently obvious that the suite of documents we produce is exactly what the regulators expect to find already in place. These documents sequentially cascade from the URS through VRA, DQ, IQ, OQ, P1Q and finish with the P2Q. This progression is of the utmost importance since the documents are inter-referenced and must be executed sequentially. This is one of the main reasons why it is important that the documents are designed and written as a package. A package that will have the correct sequential and chronological sequences authored in across all the relevant documents. HEPA Filer Compliance Issues.
High Integrity air filters have recently figured in a several very targeted warning letters. It is very important to remember they are not Fit and Forget items; you must establish the filter dirty pressure-drop (change filter) indication. (i.e filter clean pressure-drop + filter range = filter change pressure).
To reiterate; the filter manufacturers clean pressure drop value is always given at a specific flow rate. When the actual flow in your system is lower than this flow; your filter clean pressure drop will also be low and when it is high your filter clean pressure drop will also be high. You must therefore measure the flow and calculate what your pressures are to enable you to declare what the filter dirty change pressures is. Regulators expect to be able to review your documented methodology for this important task.
We have a very simply easy to use test script used for this purpose. Why not purchase it and paste it into all you SOP's and protocols that deal with HEPA filter testing.
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