Validation Master Plan

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Validation Master Plan

A manufacturer should have a VMP which reflects the key elements of validation. It should be concise and clear and contain at least the following:

‒title page and authorization (approval signatures and dates);

‒table of contents;

‒abbreviations and glossary;

‒validation policy;

‒philosophy, intention and approach to validation;

‒roles and responsibilities of relevant personnel;

‒resources to ensure validation is done;

‒outsourced services (selection, qualification, management through life cycle);

‒deviation management in validation;

‒change control in validation;

‒risk management principles in validation;

‒training;

-list of relevant SOPs

‒scope of validation;

‒documentation required in qualification and validation such as procedures, certificates, protocols and reports;

-premises qualification;

‒utilities qualification;

‒equipment qualification;

‒process validation;

‒cleaning validation;

‒personnel qualification such as analyst qualification;

‒analytical method validation;

‒computerized system validation;

‒establishing acceptance criteria;

‒life-cycle management including retirement policy;

‒requalification and revalidation;

‒relationship with other quality management elements;

‒validation matrix;

‒references.

The VMP should be reviewed at regular intervals and kept up to date according to current GMP

Glossary of terms

The VMP shall describe the process of preparation, review and approval of protocols. The major contents of protocol and report shall be defined to achieve uniformity in the documentation of various protocols.

VMP shall describe the process of execution, review and approval of the validation.

Key people / team responsibilities for validations shall be described.

The VMP shall be printed using format attached. Printing shall be done using the following guidance :

The compiled VMP will have serial pagination.

Design, drawing of the facility shall be included to as an annexure to elucidate description of the facility.

VMP will be prepared by a team, reviewed by the senior team and approved by GM QA & QC.

The VMP is a controlled document and will be reviewed once a year. Changes to VMP can be made through document change control.

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