Validation Master Plan

Pharmaceutical sites will usually create a dedicated team of validation specialists to coordinate all validation activities. They should operate according to a validation master plan that has been developed using risk analysis to identify the most critical systems requiring validation/re-validation. Before validating a system or process, a written protocol should be prepared that describes the system, the critical aspects, the objectives, the test methods and the acceptance criteria that will be applied. A validation report should be prepared on completion of each protocol. 

Berg, T., Humphreys, P., Phillips, B. and Scherz, B., Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation , PIC Publication PH 1/96. 

The results of the risk assessment prioritization can be reflected in an organizational validation master plan. Therefore, an organization can demonstrate the sequence in which they intend to address validation activities from a scheduling point of view. 

Validation master plan Document that serves as an overall guide for a facility s validation programme. It identifies all items/procedures, etc., that must be subjected to validation studies, describes the nature of testing in each instance and defines the responsibilities of those engaged in validation activities... 

The approach to validation commences with the Validation Master Plan (VMP), which details the following ... 

The change control SOP warrants particular attention. This procedure should clearly spell out how any deviations in instrument operation/per-formance, and hardware/firmware/software updates are to be handled and documented. It should also make clear what distinguishes routine maintenance, minor vs. major changes and what the procedural differences should be. The change control procedure may be a specific SOP, as part of an HPLC system s validation plan, or as part of the corporate validation master plan (VMP) that is established within each company. 

Current good manufacturing practices (GMPs) have been established all over the world. The GMPs basically serve as guidelines but do not provide step-by-step directions on how to achieve them. However, the validation master plan and associated SOPs exactly define responsibilities who, when, where, and how much is sufficient to demonstrate. 

To provide the guideline for the preparation of validation master plan to meet the design qualification requirement... 

A validation master plan, or other equivalent document, must be prepared and approved. This must be initiated at the earliest practical point and must be reviewed and updated throughout the project. The validation master plan must address all the relevant stages of DQ, IQ, OQ, and PQ. 

The validation master plan is a summary document stating the intention and the methods to be used to establish the adequacy of the performance of the equipment, systems, controls, or process to be validated. It is approved by the quality assurance, validation, production, and engineering groups. 

A validation master plan, or other equivalent document, will be prepared for all projects. 

The physical format of the validation master plan is flexible. 

The validation master plan is a dynamic document which will be reviewed, updated, and approved as required during the lifecycle of the project. 

Where appropriate and documented in the validation master plan, the IQ and OQ protocols may form a single document which clearly defines the acceptance for each test(s). 

The room temperature should be in compliance with the room requirements, per validation master plan, at rest and dynamic conditions. 

Average measured clean air velocity shall be according to designed standard specified in the validation master plan at 6 in. downstream from the filter face. Velocity differences within the same plenum should be no more than 25%. 

The relative humidity at each grid point shall be within the specihed levels and tolerance limits indicated for each room in the validation master plan. If these levels are attained, the system is accepted. 

The recovery time should be not more than 2 minutes or as specified for individual work zone in the validation master plan. 

This book and CD-ROM provide an administrative solution for management. The execution of test functions defined in the validation master plan procedures is provided in the text and the electronic files. The validation standard operating procedure can help your company comply with GMP, GLP, and validation requirements imposed by the FDA. 

Scope of Validation Processes Validation Master Plan Validation Protocols and Reports... 

Validation activities should be described in a validation master plan which provides a framework for a thorough and consistent validation. Regulatory agencies typically do not specifically demand a validation master plan. However, inspectors want to know the company s approach toward validation. The validation... 

Within an organization, a validation master plan can be developed for ... 

For larger projects, an individual validation project plan should be developed. This plan is derived from the validation master plan. It formalizes qualification and validation and outlines what has to be done to get a specific system into compliance. For inspectors it is the first indication on the control that a laboratory has over a specific computerized system, and it also gives a first impression of the validation quality. 

Develop a validation plan and schedule using your validation master plan as a guideline. 

---