VALIDATION MASTER PLAN (VMP)
The Validation Master Plan (VMP) is a document that has never been mandatory, but is always one of the first documents a regulator asks to view. This is an extremely important document because in constructing it, many serious 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
Design Qualification (DQ), 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 prospective progress of the project is there for everyone to compare to the actual progress. The VMP) is a document that documents the way the company will operate, who has control over the various aspects of the validation activities, and how production, quality control, and man management will be directed.
The document should cover the following subjects but
should not limited to them alone:
- Plan Origin and Approval.
- Scope of Validation Activities.
- Validation Objectives.
- Validation Plan Review.
- Roles and Responsibilities.
- An Overview of Activities.
- Division of Responsibilities.
- System Description.
- Overview of System.
- Overview of Process.
- System Description.
- Validation Approach.
- Site Activities.
- Documentation and Procedures.
- Scope of Documentation.
- Validation Schedule of Activities.
- Project Master Schedule.
Validation Master Plan in the Qualification Process.
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.
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.
Facility building overall location and access.
Facility production/clerical/storage/controlled areas, rooms or
Raw material ingress and finished product egress routes.
Personnel ingress and egress routes, along with changing areas.
Controlled atmospheric areas along with air flow directions and
Dressing codes for these controlled areas.
VALIDATION MASTER PLAN.
SEARCH AND FIND
SOP for Spreadsheet Creation.
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
SOP Equipment Validation.
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.
Purchase your copy now at Special Price of $22.00.
Equipment combined IQ/OQ/PQ Protocol.
Equipment Combined IQ/OQ/PQ Protocol (Issue-2). -- $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. 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.
Validation Risk Assessment.
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.
Now click here for further details on this SOP
covering Validation Risk Assessment and 21 CFR Part 11 application.
Validation Risk Assessment (Issue10.) -- $125.00