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Latest Issue Protocols.
September 02, 2013

Latest Issue Protocols.

It is that time of year again; the time when all these little and sometimes not so little document updates have to be incorporated and working documents brought into line with regulatory interpretations.  I use that word deliberately simply because all regulations are open to interpretation.  However in our industry it is always advisable to ascertain what the regulatory interpretations are; then incorporate them into them into your strategy.  It can be very lonely arguing your opinion with an assertive regulator while your incensed chairman is quietly seething.


We have incorporated a number of comments and observations that originated with our regulatory colleagues.  Purely on the bases that when we arrive at the debrief stage; we will escape some of the “would have been better” comments.


First six documents updated are the popular tripartite IQ/OQ/PQ combined protocol documents one each for Computer / Software / Climatic Controlled Zone  / Lab Equipment / Quality Steam validation. Click here to view.


We are getting close to releasing our first tutorials that will be in the form of multi-choice questions.  If that is of interest click on our mail link to receive our mail letters and we will include you from the start.

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.

HEPA Filter Clean PD Correction - $26.00.

No matter whether you use our templates or completed protocols using our IQ, OQ and PQ documents along with their interrelated plans and assessment documents produces the thorough audit trail needed to meet all internal or external regulatory reviews or inspections.

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