Insert Company Name

Validation Master Plan (VMP) for

Enter the title of the VMP

Enter Project #

Author: Insert Author Name

Role: Job Title

Issuing Department: Department Responsible for the VMP

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Title: [Enter Title of VMP Project] Revision: [Insert Rev]
Author: [Insert Author] Project #: [Enter Doc #]

TABLE OF CONTENTS

1. PURPOSE ....................................................................................................................... 3
2. SCOPE............................................................................................................................ 3
3. REFERENCE .................................................................................................................. 3
4. ABBREVIATIONS AND DEFINITIONS ............................................................................ 3
5. ROLES AND RESPONSIBILITIES .................................................................................. 3
6. OVERVIEW OF PROCESS / SYSTEM ........................................................................... 3
7. VALIDATION LIFECYCLE APPROACH .......................................................................... 3
7.1. Validation Activities ...................................................................................................... 3
7.2. Acceptance Criteria...................................................................................................... 4
7.3. Qualification ................................................................................................................. 4
7.4. Re-Qualification ........................................................................................................... 4
7.5. Qualification Results .................................................................................................... 4
8. ATTACHMENTS ............................................................................................................. 5
9. APPROVALS................................................................................................................... 5

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 Title: [Enter Title of VMP Project] Revision: [Insert Rev]
Author: [Insert Author] Project #: [Enter Doc #]

1. PURPOSE
Describe what the VMP is for

2. SCOPE
Describe the scope of the VMP; What does this apply to? What does this exclude?

3. REFERENCE
List all references to documents, forms, records or other documents that are to be used or called
out in the VMP.

Reference Name or Title Document ID

4. ABBREVIATIONS AND DEFINITIONS

List any abbreviations or wording in the document that needs to be defined.

Term Definitions

5. ROLES AND RESPONSIBILITIES

Role Responsibilities

6. OVERVIEW OF PROCESS / SYSTEM

6.1. Step
6.1.1.Step
6.2.

7. VALIDATION LIFECYCLE APPROACH

7.1. Validation Activities
7.1.1.
7.1.2.

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 Title: [Enter Title of VMP Project] Revision: [Insert Rev]
Author: [Insert Author] Project #: [Enter Doc #]

7.1.3.
The validation activities shall outline the overarching plan:
1) Quality Assurance Plan
2) Regulatory Plan
3) Risk Plan
4) Manufacturing/Production Plan
5) Facilities Plan
6) IT Plan
7) Logistics Plan
8) Human Resources Plan
9) Conclusion

Examples of what Validation Activities should include:

 Each VMP shall describe the scope of activities and address relevant key elements of validation
affected by the change, indicating the actions and documents that will be needed. The key
elements are those factors that can have an effect on product quality.
 The VMP shall identify all the components to be included within a validation project. Flow
diagrams or matrices can be useful to provide an overview and monitoring tool. A high level
process map or flowchart of the manufacturing process should be included.
 Following the issue of the VMP, detailed risk assessments (system and component impact
assessments) should be carried out to identify items requiring qualification.
 Acceptance criteria related to the customer specifications and what is required of the project
shall be defined
 The content of the VMP should reflect the complexity of the extent of the validation activities to
be undertaken.

7.2. Acceptance Criteria

Description of the validation activity acceptance criteria and allowance.

7.3. Qualification
Description of components tested to meet requirements.

7.4. Re-Qualification
Define what constitutes a change to the status of the validation.

7.5. Qualification Results

Define when the qualification was completed.
7.5.1.Step
7.5.1.1. Step

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 Title: [Enter Title of VMP Project] Revision: [Insert Rev]
Author: [Insert Author] Project #: [Enter Doc #]

8. ATTACHMENTS
Attachment Number Attachment Description

9. APPROVALS: DATE:

_____________________________________________ ________________________
Quality Assurance

_____________________________________________ ________________________
Process Engineer

_____________________________________________ ________________________
VP of Operations

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