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Tuesday, May 24, 2022

Validation Master Plan Definition of Validation Master Plan

What is the Validation Master Plan Definition of Validation Master Plan?

Why is the validation master plan important in the Pharmaceutical Manufacturing Industry?

Is it made mandatory by US FDA to make A Validation Master Plan ? No it's not Mandatory by USFDA Guidelines.

Is Validation Master Plan document Mandatory as per WHO Guidelines ?  Yes It is mandatory by WHO GMP Guidelines.


As per USFDA guidelines as per 21 CFR part 820 Validation Master Plan document is not mandatory while guidelines have made Validations mandatory. WHO Guidelines make it mandatory to make a Validation Master Plan.

Any medicine or Drug or Pharmaceutical product is termed as spurious, and not complying with good manufacturing practices if they are not manufactured in a facility that does not hold validated, systems, Procedures and Processes and validated equipment.

In order to maintain the status of manufacturing unit complying to Good Manufacturing practices, every system, Procedures and Processes and equipments which are used for manufacturing of Pharmaceutical products are required to be validated and revalidated on time.

Therefore Regulatory agencies demand from manufacturers about their plan to keep these things validated though out the lifecycle of the manufacturing unit.

Definition of Validation Master Plan.

Document which describes plan in sequential manner with specified timelines, the plan for conducting validations as well as revalidations programs or projects for their needs of particular pharmaceutical Manufacturing units, Systems, Procedures and Processes and validated Equipment, validation Master Plan also describes the current status of validation of manufacturing units systems, Procedures and Processes and validated equipment.

This plan is required to approve by the doers and the Quality Assurance Manager and Directors of the Pharma Manufacturing company.

Validation Master Plan document is a tool to assess the compliance status of the pharmaceutical manufacturers towards the Good Manufacturing Practices though prompt validated systems, Procedures and Processes and validated equipment which also includes revalidation plan 

While conducting the Validations and Revalidation there are many factors of Quality Management System which are required to be considered.

1) A properly filed and approved Change Controls.

2) Properly identified Training needs to conduct a Validation Program or Validation Project.

3) Risk assessments, and the mitigation strategy for identified risks.

4) Area Qualification.

5) Equipment Design Qualifications.

6) Equipment Installation Qualifications.

7) Equipment Process Qualification.

8) Cleaning Validation.

9) Analytical Method Validations.

10) Computer System Validations.

11) PLC program Validations.

12) Deviations during validations and Corrective and Preventive Actions taken.

14) Personnel Validations, checker validations, analyst Validation.

15) Validations of decontamination and sanitization Procedures.

16) Calibratios Procedures Records.

17) Past Validation History.

18) Certificates of measurement instruments.

19) Utility Qualifications.

20) Requalifications 

21) Role and Responsibilities of doers and reviewere and approving authority.

Validation master plan should describe in details the validation plans of the entire manufacturing unit, with current status as well as way forward strategy considering the past compliance actions and future planned actions.

Validation Plan Matrix is required to prepare, Validation Matrix must list the requirements of validations in orderly manner so that if followed will enhance the compliance status of Manufacturing unit in a systematic manner.

Regulatory agencies review the availability of Validation Master Plan for assessing overall compliance status of Pharmaceutical Manufacturing unit with respect to validated processes, procedures and equipment are adapted for manufacturing of pharmaceutical products. 

21 CFR PART 820 guidelines about Process Validation.




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