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VALIDATION MASTER PLAN (VMP)

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VMP AN OUTLINE

The Validation Master Plan (VMP) gives an overall depiction of the company facilities, along with the management structure, and details of how cGMP is, or is to be, integrated with all company activities.

The VMP must be an overall document, it should not get bogged down in detail. 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 validation documentation eminating from the VMP to the VP, URS, DQ, IQ, OQ, P1Q, and P2Q. With the interaction of the VRA, VA, and 21 CFR Part 11.
Facilities are portrayed in two basic ways, Engineering Drawings and Equipment lists. Drawings are an essential element in the Validation master plan, and show simply and immediately an overall picture of the plant size and capabilities. They must include.
  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 atmospheric areas along with air flow directions and pressure regimes.

  8. Dressing codes for these controlled areas.

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EQUIPMENT LISTS.

Equipment Lists:These lists must be be comprehensive, to give a reviewer a quick overview of the company facility that is to be, or has been, qualified. A matrix type layout portraying the information listed below, can usually work very well.
  1. The equipment title, part number and serial number.

  2. The calibration status.

  3. The maintenance status.

  4. The validation status.

  5. The location of equipment.

  6. The production use of the equipment.

  7. Ancillary lists should include, Valves, Gauges, and company issued serial numbers.

The VMP must show the management structure with titles being used rather than names. A path must be shown flowing from QA at production level (but independent from production) up to director level. Other than this the organogram should show the routine and usual commercially driven structures. Management responsibilities regarding all aspects of validation should be detailed, preferably using a separate organogram.

The VMP should now show how cGMP is integrated into everyday activities and procedures in the facility.

Validation Methodology should be described in detail, showing the interrelationships between the VMP and the individual Validation Plans (VP’s). The use, scope and responsibilities for producing, approving and executing, of Site Acceptance Testing (SAT) and Factory Acceptance Testing - FAT - protocols. Similar details should be given on the relationship between these VP’s, Risk Assessments and the scope of the;Design Qualification - DQ -, Installation Qualification - IQ -, Operational Qualification - OQ - and Performance Qualification - PQ -.

THE VMP & FULL LIFE CYCLE VALIDATION.

BASIC VALIDATION RELATIONSHIPS.

VALIDATION MASTER PLAN


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