Definition: Validation Master Plan (VMP)
The VMP is used to illustrate the practices and procedures that are used by a company to ensure all regulated activities are compliant with 21 Code of Federal Regulation Part 11, 210, 211 and 820 legislation.
The VMP is a document that the regulatory inspectors have not mandated a format for; but have mandated a requirement for. The VMP is intended to project a picture of how your company has integrated ”current Good Manufacturing Processes” (cGMP); as promulgated in 21 CFR Part 820 & 211, into all aspects of the manufacture of a regulatory controlled product.
Even although the VMP is not mandated; 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.
In authoring the VMP 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 VMP, 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.
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, organisation 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.
It must define the range of documentation spreading from the VMP to the VP, URS, DQ, IQ, OQ, P1Q, and P2Q. It must explain and detail the company’s approach to risk based validation and the interaction of the VRA, VA, 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.
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Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.
SOP for Spreadsheet Creation. -- $125.00
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.
SOP Equipment Validation.
Purchase your copy now at Special Price of $22.00.
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.
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.
It now appears that the current FDA Guidance rules pertaining to 21 CFR Part 11 may be with us for a longer time than was originally anticipated. So we have incorporated the guidance suggestions in their latest guidance document, into our current Validation Risk Assessment (now issue 10), which is now available for immediate download. This VRA document now comes with a downloadable matrix for registering the justification for all your Part 11 assessments as this is now a mandatory requirement.