This document outlines the specific requirements of a Validation Master Plan (VMP) for a pharmaceutical company. It discusses 11 key sections that should be included in a VMP: 1) approval page and table of contents, 2) introduction and objectives, 3) plant and process description, 4) personnel, planning and scheduling, 5) responsibilities of committee members, 6) process control aspects, 7) equipment and apparatus to be qualified, 8) processes and systems to be validated, 9) acceptance criteria, 10) documentation, and 11) SOPs. The VMP provides a complete scope and timeline for validating all facilities, equipment, materials, and processes to ensure regulatory compliance.

1. SPECIFIC REQUIREMENTS
OF VMP
Submitted by,
Jikhila Machado
1st M. Pharm

2. SPECIFIC REQUIREMENTS
1) Approval page and table of conent
Documentary should be prepared by one person, checked by another
person and approved and authorized by head of QA
2) Introduction and objectives
Objectives may be,
- To validate, all facilities, equipments and processes in this plant
- To provide detailed guidelines on validation activities to be done in
this plant
- To meet the regulatory compliance as per the current GMP guidelines
of the country in which the products are to be marketed.

3. 3) Plant and process description
- Brief outlineof the plant ie. Where it is situated, age of the plant, technology used etc
- matrix of processes used in the plant –can be given formulation wise which helps to
identify the scope of validation work.
4) Personnel, Planning and Scheduling
- organization of validation department to provide the auditor the
confidence in the work of validation.
Planning – Is what you are going to do
Gives the complete scope of the work
• Facility validation
• Equipment validation
• Material validation

4. Scheduling –Is when you are going to do.
- should give time table of when it will start and end
• date of start
• date of completion
• Remarks
5) Responsibilities of committee members
Should be described in brief but in unambiguous manner.
Eg; The responsibilities of head of validation team is,
• To identify the legal and regulatory requirements for validation
• To select and train team members
• To execute the plans timely.

5. 6) Process control Aspects
Have to identify all the controls used go monitor during the process
validation and other activities.
7) Equipments and Apparatus to be qualified
A list must be prepared on the activity which is required to be performed
and should be tick marked after the process.

6. 8) Processes and System to be validated
a) List of processes to be validated
•Shifting
•Mixing
•Milling
•Autoclaving
•Filling
•Compression
b) List of systems to be validated
•HVAC
•Purified water
•Water for injection
•Granulation of tablet

7. 9) Acceptance Criteria
Shouldclearly define the parameters in eachvalidation activity and limit of acceptance.
10) Documentation
List of all documentsrelated to validation activities
11) SOPs
List of SOPs related to validation activities alongwith calibration activities also.
12) Training Requirements
Identifying all persons who are responsible for carrying out various validation activities
and their training needs and how it will be satisfied

8. REFERENCES
■ cGMP for pharmaceuticals by, Manohar. A. Potdar, page no;
427-431
■ Text book of pharmaceutical technology concepts and
application by, S. Bharath, page no :283-293
■ Validation in pharmaceutical industry by, P. P. Sharma, 1st
edition, 2007 page no;85-95

9. THANK YOU