What is validation master plan flow chart

Validation
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What is the validation master plan and its flow chart

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VMP describe the entire validation of the factory.
It ensures that all pharma equipment, utelities and facilitiesare qualifiedā€¦and maintain validation statusā€¦ progressivenessā€¦
This should include
Site details, details of equipment-QC, Production
All utelitiesā€¦all qualifications activity

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Dear All,

What are the attachment and schedule should be provided with VMP?
thanksā€¦

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Hello , I am new in the field of quality assurance, can someone help me through a pdf or video that explain validation master plan ?
Thank you

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Reference: WHO-Annex 3, TRS- 1019-2019
Good manufacturing practices: guidelines on validation

A manufacturer should have a validation master plan that reflects the key elements of validation. It should be concise and clear and at least contain a reference to/have a short description of the following:
ā–  title page and authorization (approval signatures and dates);
ā–  table of contents;
ā–  abbreviations and glossary;
ā–  validation policy;
ā–  philosophy, intention, and approach to validation;
ā–  roles and responsibilities of relevant personnel;
ā–  resources to ensure that qualification and validation are done;
ā–  outsourced services (selection, qualification, management through the life-cycle);
ā–  scope of qualification and validation;
ā–  documentation required in qualification and validation, such as procedures, certificates, protocols, and reports;
ā–  premises qualification, such as room verification where appropriate;
ā–  qualification of utilities;
ā–  equipment and instrument qualification;
ā–  process validation;
ā–  cleaning validation;
ā–  personnel qualification (such as analyst qualification);
ā–  analytical method validation;
ā–  computerized system validation;
ā–  establishment of acceptance criteria;
ā–  life-cycle management, including retirement policy;
ā–  requalification and revalidation;
ā–  relationship with other quality management elements;
ā–  validation matrix (such as a table indicating the history and status of qualification and validation on-site);
ā–  retention of qualification and validation documentation;
ā–  deviation management;
ā–  change control;
ā–  risk management principles;
ā–  training;
ā–  references.

According to the current GMP, the validation master plan should be reviewed at regular intervals and kept up to date.

Reference:
PHARMACEUTICAL INSPECTION CONVENTION
PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME
PE 009-15 (Annexes), 1 May 2021
The key elements of the site qualification and validation program should be clearly defined and documented in a validation master plan (VMP) or equivalent document.
The VMP or equivalent document should define the qualification/validation system and include or reference information on at least the following:
i. Qualification and Validation policy;
ii. The organizational structure including roles and responsibilities for qualification and validation activities;
iii. Summary of the facilities, equipment, systems, processes on-site and the qualification and validation status;
iv. Change control and deviation management for qualification and validation ;
v. Guidance on developing acceptance criteria;
vi. References to existing documents;
vii. The qualification and validation strategy, including requalification, where applicable.

The attachments to the Validation Master plan (VMP) should be as follows,

  • Validation policy
  • Man & Material movement in the plant (Layout)
  • Validation Master schedule (Manufacturing equipment)
  • Validation Master schedule (QC instruments)
  • Process performance Qualification schedule (Process validation)
  • Cleaning validation schedule
  • Utility validation schedule
  • Analytical Methods validation schedule
    ( Above schedules should also include re-validation and re-qualification schedules)
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Thank you so much.

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You are always welcome.

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@sunilrbudhkar thank you so much ; i appreciate your help

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You are always welcome.