"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. 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.
This Validation, 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 very significant difference to the man hours required to produce and execute these documents. 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 costs without infringing regulatory standards.
4Q Equipment Validation 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 validation documentation 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, it is still written in word.
The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.
The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it somtimes is the fact that the product is a very expensive product, and can not be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste.