VALIDATION

The Validation Master Plan Template (VMP); sometimes termed Master Validation A 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 Validation Master Plan Template, 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 A Master Plan Template 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.

In authoring the Validation A Master Plan template 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 A 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 A Master Plan template, 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 template (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 A activities and allot responsibilities for authoring, reviewing, approving, and executing validation A documentation and tasks.  The Validation Master Plan template 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 template 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 A documentation and tasks. 

The Validation A master plan template must define the range of documentation spreading from the Validation A Master Plan template to the VP, URS, DQ, IQ, OQ, P1Q, and P2Q.  It must explain and detail the company’s approach to risk based validation A and the interaction of the VRA, Master Plan template, 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.

Since we are all operating validation which we deem to be  "Risk Based" we are required to ensure that the Validation Master Plan template (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 Validation Master Plan template  is a robust and simple document to execute, 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).