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FDA Inspection Issues
August 16, 2013

Validation Risk Assessment (VRA).

The easing of the requirements detailed in 21 CFR Part 11, has lead to other requirements being mandated.  These requirements along with the task of defining the actual scope of validation that is adequate can be satisfied when a risk assessment is used to assess various aspects of the equipment / software use and possible effects on the subsequent efficacy, quality and record integrity of the controlled product.

This makes the Validation Risk Assessment (VRA) a somewhat essential document to have and use.  It is a mandatory requirement that certain aspects of this assessment are documented and held as a regulatory required record.  These include;


Does the software/equipment require Full Life Cycle Validation (FLCV)?

If not FLCV then what scope will the regulators consider adequate?

Does the equipment/software produce records that must comply with 21 CFR Part 11?

If the data requires to be Part 11 compliant, how is that to be being achieved?


The answers to these questions are required to enable the Validation Plan to be properly scoped and contain sufficient information to direct and control the protocol writers, to ensure they define the correct content for the IQ/OQ/PQ protocols.  


The VP must then be used by the protocol writers as the official mandate for protocol content 

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.

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