"A validation quality plan must define, detail and mandate means and methods by which an approved change control concept can be progressed through the regulatory qualification process and into cGMP compliant production"
The Validation Quality Plan (VQP) is probably the most important of
all documents in a validation project. It is an essential document in giving
assurance that the validation task can be successfully executed in an effective, timely
and cost effective manner
. Simply because
this is the stage in the operation where all aspects of the validation are
highlighted, debated, allotted and budgeted for. Once the full scope of the
validation task is unearthed; then and then alone, can all these facets be
catered for and sensible time lines and responsibilities deliberated. To this end there may be several VA in
any major validation project. Each VP will cover
identical or similar equipment where the validation responsibilities and scopes
are identical or similar and can be adequately defined in one validation quality plan.
The top level of the User
Requirements Specifications (URS) must be in place to enable
the author(s) of the VP to start assessing; not only the basic user level
requirements but the attendant needs that the user level requirements make
requisite, such as; staff levels, user training, maintenance training, utility
and facility loadings. Along with
these requirements will come a multitude of other minor and major issues that
only ever become obvious after such extended and invasive studies are
completed. Only when these
requirements are fully reviewed and documented, can they be accurately
quantified. However once they are
defined, then the VP can start to allocate and document individual staff
responsibilities and individual and collective achievable time lines. Now the stage has arrived where a defined,
detailed and workable validation quality plan can be documented, reviewed, and subject
to reviewed comments being incorporated; issued by management as the official Validation
Quality plan of action.
The VP is the document that the company must use to authorize actual validation
methodologies, scopes and associated individual responsibilities (by job
title). It therefore has to work hand in hand with the
Risk assessment(VRA). The VA must list all the equipment that
it applies to and the VRA must be executed against each of the items in this
list. On completion of each
execution the appropriate scope of validation will be indicated by the VRA. This scope must be entered into the
appropriate section of the VP, before it becomes an approved and locked
controlled document. The VP will
therefore list the scope of validation applicable to each listed item along with
any individual specific methodologies that should be used.
The Validation Master Plan (VMP) is the single most important document because it describes the basic concept for your overall site validation program. This interactive detailed document is a delight and simple to use. The generic template and attached SOP lead you through the whole process quickly and seamlessly. This thirty page document is suitable for all types of pharmaceutical /biotechnical / medical device / API, manufacturer and or processer. The VMP addresses process validation, facility validation, utility validation, equipment qualification and cleaning validation. The objective is to define responsibilities, outline your methods involved in the qualification and validation of your facility, define the areas and systems to be qualified and validated and to provide a program for achieving and maintaining a validated status.
The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
Purchase your copy now at Special Price of $22.00.
The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
Equipment combined IQ/OQ/PQ Protocol.
This combination protocol has been produced in response to several
hundred reader suggestions we received in our ‘Suggestions Section’. It
has been carefully designed to make it the preferred choice for Process
and Laboratory stand alone equipment. It is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.