VALIDATION MASTER PLAN



Validation Master Plan Rationale.

Even although the Validation master plan is not a mandated document; it inevitably will be the first document regulators will ask to review.

The Validation Master Plan (VMP); sometimes termed Master Validation Plan (MVP) is used to display or present an overall picture to visiting auditors, of how the company has integrated cGMP into its day to day activities.

These auditors have not mandated a strict format for the VMP to follow; however, they have projected an expectation that they expect to be able to review such a document and that such a document must project a picture of how your company has validation master plan has integrated ”current Good Manufacturing Practices (cGMP); as promulgated in 21 CFR Part 820 & 211, into all aspects of the manufacture of a regulatory controlled product.

Even although the Validation master plan is not a mandated document; it inevitably will be the first document regulators will ask to review. This is because they expect this document to clearly and concisely illustrate to them how management has delegated responsibilities, designed product processes, planned resources usage and established a fully trained competent work force. They will look for evidence to convince them that there is sufficient ongoing training to maintain these standards and sufficient auditing to prove it.


Validation Master Plan Compliance.

In authoring the Validation Master Plan extremely important commitments and decisions have to be made.

In authoring the Validation Master Plan extremely important commitments and decisions have to be made. Program conceptions have to be mated to the User Requirements Specifications (URS), Level 1, 2 and or 3, these specifications have to be mated to the VP or VMP. From these plans the User Requirements Specification (URS),  the Validation Risk Assessment (VRA), the Design Qualification (DQ), the Installation Qualification (IQ), the Operational Qualification (OQ), and the Performance Qualifications (PQ) have to be authorized, authored, approved for content, and issued for execution. The completed documentation has to be reviewed and accepted as complete by persons authorised to execute this role. All of these functions must be detailed in the Validation Master Plan, when the project concept demands that a VMP is required, or the Validation Plan (VP) where it does not. Responsibilities have to be declared, people have to be nominated, and everyone involved is duly served with a copy that carries the full authority of the company.


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This graphic depicts our copyright protection Validation Master Plan statement.

Validation Master Plan Techniques.

The Validation Master Plan must comply with all the appropriate requirements documented in 21 Code of Federal Regulation Part 11, 210, 211 and 820

The Validation Master Plan (VMP) must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview of how the company has integrated all applicable current Good Manufacturing Practice (cGMP) requirements into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks.  The Validation Master Plan must comply with all the appropriate requirements documented in 21 Code of Federal Regulation Part 11210, 211 and 820 legislation.


This graphic depicts the Validation Master Plan document requirements.

Validation Master Plan Guidance.

The Validation Master Plan is a top layer document and should not go into specific detail.

The Validation Master Plan is a top layer document and should not go into specific detail; but present an overall picture of the company facility, organization and capability.  It must give a clear and concise overview, to a reviewer, of how the company has integrated all the applicable cGMP requirements into every aspect of its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks. 


The Validation master plan must define the range of documentation spreading from the Validation Master Plan to the VPURS, DQIQOQP1Q, and P2Q.  It must explain and detail the company’s approach to risk based validation and the interaction of the VRAValidation Plan, and 21 CFR Part 11.


Facilities are portrayed with the use of layered drawings; where different layers show individual systems and equipment lists give equipment type and identity details. It is normal to include layered drawings to enable a clear and easily observed presentation of the following systems.

1)      Facility building overall location and access.

2)      Facility production/clerical/storage/controlled areas, rooms or zones.

3)      Raw material ingress and finished product egress routes.

4)      Personnel ingress and egress routes, along with changing areas.

5)      Utility Layouts

6)      Electrical layouts

7)      Controlled areas along with air flow directions and pressure regimes.

8)      Dressing codes for these controlled areas.


Risk Assessment and VMP

we are required to ensure that the VMP  ensures that all validation activities mandated in the Validation Master Plan 
(VMP) are risk assessed.

Since we are all operating validation which we deem to be  "Risk Based" we are required to ensure that the Validation Master Plan (VMP) dutifully ensures that all validation activities mandated in the VMP  are assessed by the execution of a Validation Risk Assessment (VRA) protocol.

The VRA is fast 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).

VALIDATION MASTER PLAN



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Validation Master Plan (Issue 8) -- $115.00

All you need to do is follow the prompts in the attached SOP.  They will take you through the completion process section, by section.  At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document.  The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols.  A great document to author and use.  This document interfaces with our Validation Online Risk Assessment  (VRA), Validation Online Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.



Validation Plan (Issue 10) -- $93.00

The Validation Plan (VP), is the starting point for any validation task, and the most important validation Online document. It improves validation efficiency greatly by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is a mandated document with regulators and auditors.

While in the past validation was more focused on functions of procedures, recently the focus has progressed into infrastructure, networked systems and on security, authenticity and integrity of data acquired and evaluated by 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 (weeks of work 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.



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 User Requirements Specification.

Quantity

Process Qualification (P2Q) (Issue 3.) -- $85.00

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.



12000002 VrrP Equipment $298.00

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 master plan 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.



12000006_4Q_Equip_iss-4. -- $298.00

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.