Validation Master Plan
VMP is basically a summary of the overall strategy for the validation of equipment, utilities, processes, systems, or procedures along with supporting rationale. It comprises the overview of the validation process (Prospective, Concurrent, Retrospective Validations, and Re-validation) with its structure and planning. The documented information cannot be repeated but references to existing documents can be mentioned (e.g. Policy Documents, SOP’s, and Validation Protocols/Reports). It provides the demonstration of the process or equipment that it perform as per the design and give intended results. It envisions the organization’s commitment to GMP. Separate VMP can be created in the case of large projects.
i) Description of validation policy, operation, location, and schedule of the firm
ii) The organizational structure of all validation activities including protocols, reports of every stage, personnel responsibility,
iii) Description of process and facilities
iv) A rationale for validation and its approach (including the rationale for processes not validated) and any challenge including worst-case & purpose of validating worst case.
v) Specific considerations of every process that is critical for quality product yield.
vi) List of all the products/processes/systems to be validated.
vii) Acceptance criteria for all the products/processes/systems to be validated.
viii) Formats for documentation of protocols and reports should be described.
ix) A list of SOPs required should be mentioned
x) Plan & schedule should be mentioned
xi) Statement for controlling critical changes of materials, facilities, equipment, or processes.
xii) Computer system validation
xiii) Additional cGMP programs
xiv) References
It is a policy document that enlists the various aspects of validation such as “Why what, where, by whom, how and when?”. This document describes the overall validation program with the schedule and responsibilities of the individual in performing the validation task. It serves as a guide to the validation team, steering committee, and personnel, who are responsible for implementing the validation protocols. It acts as a source document to identify tasks and responsibilities and should assist regulatory inspectors to understand the manufacturer’s approach to validation and how the validation activities are organized and managed. It helps management to know what the validation program involves with respect to time, people and money, and to understand the necessity for the program.
