A Master Validation Plan will necessarily have to have inputs that go on to make it free of cGMP deficiencies. To ensure this, a keen understanding of the regulatory requirements and processes is necessary. This is all the more important, considering that the FDA has come out with a new, tougher regulatory stance in this regard.

To meet these requirements, the Master Validation Plan has to incorporate the hazard analysis and product risk management standards set out in ISO 14971 and ICH Q9. A company that sets out to do this has to have a proper grasp of different field-tested, FDA-reviewed V&V protocols, as well as knowledge of how to employ equipment/process Requirements Specs/DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500. Importantly, it has to have the ingenuity to do all these against a background of limited resources.

A detailed V & V plan

The key to fulfilling all this is putting in place a matrix that simplifies “as-product”, “in-product”, process and equipment, and software VT&V, to assure key FDA requirements are not overlooked. Such a matrix should also consider the QMS and 21 CFR Part 11.

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Understand verification and validation, their differences and how they work in tandem;

Get a grasp of regulatory requirements on the same

Know how to document a “risk-based” rationale and use it in a resource-crunched situation

Understand sample sizes and their justification

See how to compile a QMS Electronic Records and Electronic Signatures Verification and Validation that satisfy 21 CFR Part 11, and

Get much, much more.