VALIDATION QUALITY PLAN



"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"


Validation Quality Plan.

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 Validation 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.


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Validation Quality Plan Scope.

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.


The VP Role In The Validation Process.

Graphic represents protocolsan validation plans used in full life cycle validation.

Validation Quality Plan Progress.

Graphic portrays the interrelationships between protocolanmd specification used in our validation plan.

VALIDATION QUALITY PLAN.



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation 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 procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A 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 medical device validation template; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.



User Requirements Specification Template
$115.00

The User Requirements Specification template is the document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected for cGMP use that all essential support elements; i.e. maintenance, parts, operator & maintenance training, are planned and budgeted for.  It uses three levels of User Requirements Specification Template (URS), URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final OQ and PQ functionality testing. A requirement mandated by cGMP regulations. It can be used on mechanical, electrical and software controlled, monitored or driven systems. 



Corporate Validation Manual $1,160.00

This definitive 1000 + page (including all attachments) Corporate Validation Manual arrives with you in USB memory stick format, this enables you at any time to download protocol or test-scrips documents and quickly edit them into company bespoke documents. In fact there are over $3,500.00 worth of superb documents, that form attachments to the DVM manual, which can be instantly copied. Once copied, the unique document interactive editing, allows you to produce high quality bespoke company documents; Such as the Validation Plan Template or the equally ubiquitous User requirements Specification template Design Qualification (DQ); in a few hours. The cost of the Definitive Validation Manual, will be recouped in the first few weeks of use. It will then go on to show a massive return on your original investment.