"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 /bio-technical / medical device / API, manufacturer and or processor. 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.
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Equipment combined IQ/OQ/PQ Protocol. $159.00
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 and associated standard operating procedures. The associated Validation Master Plan is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that all validation Online executables are catered for and that key aspects of the equipment adhere to approved design intentions and 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 documented process validation executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the URS.
The Process Validation or Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorded and reviewed with a view to ensuring that the deviances (within permitted tolerances) that exist are random and not a trend that could lead to out of specification produce being produced.
This Validation 4U, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. This new format will make a significant difference to the man hours required to produce and execute these standard operating practice process validation executables. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
This is an essential step forward for companies seeking to reduce validation 4U costs whilst remaining compliant with their Corporate Validation Manual.
4Q Equipment Validation 4U Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining process validation Online executables documentation and associated standard operating procedures, by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, the Corporate Validation 4U Manual template is written in written in word.