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XXXXXX Pharmaceutical Inc. Document No. XXYYZZ-AABB
PAGE
PAGE 11
XXXXXXX Pharmaceuticals Inc.
Document No.:
Issued on
Supersedes:
mm/dd/yyyy
Validation Master Plan
For
XXXXXXXX
Version No.:
Reason for the Revision
Date:
Prepared by:
Name
Title/Department
Signature
Date
Reviewed by:
Name
Title/Department
Signature
Date
Approval by:
Name
Title/Department
Signature
Date
TABLE OF CONTENTS
Introduction
Purpose
Scope
Product Description
Facility and Equipment Description
HVAC System
Water System
Manufacturing Equipment
Process Description
Step 1
Step 2
Step 3
Analytical Methods
Personnel Training
Validation Approach
General
Equipment and Critical Utilities Qualification
Cleaning Validation
Manufacturing Process Validation
Validation of Computer System (if any used)
Analytical Method Validation
Validation of Acceptance Criteria
6.7.1. Equipment and Critical Utilities Qualification
6.7.2. Clean Validation
Process Validation
Analytical Method Validation
Validation Documentation
Change Control
Validation Organization
Validation Schedule
Responsibility of Validation Team
References
Attachments
INTRODUCTION
Purpose
The purpose of this document is to provide the Validation Master Plan (VMP), including and not limit to equipment qualification, critical utility system qualification, process validation, cleaning validation, analytical method validation and product quality control. This document defines the current validation operations, validation organizational structure, their content and planning. Any process changes will require an updating of this VMP in order to fulfill general validation purpose.
Scope
This Validation Master Plan covers following:
Equipment and facility used in the production
Cleaning procedures for critical process equipment
Critical utility systems
Analytical methods
XXXXXXX manufacturing process
Product Description
XXXXXXX is oral solid dosage form (tablet) produced by wet granulation,
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