Learn how the Validation Master Plan (VMP) 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 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 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 (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. It must comply with all the appropriate requirements documented in 21 Code of Federal Regulation Part 11, 210, 211 and 820 legislation.
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.
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.
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The Risk and Part 11 Validation Risk Assessment (VRA) protocol is 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).
Equipment combined IQ/OQ/PQ Protocol.
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.