ABSTRACT

The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and rel

chapter 1|8 pages

INTRODUCTION

chapter 2|26 pages

CONCEPT OF QUALIFICATION/VALIDATION

chapter 3|2 pages

REVALIDATION

chapter 4|6 pages

FACILITY DESCRIPTION

chapter 5|4 pages

DESCRIPTION OF BUILDING

chapter 6|10 pages

EQUIPMENT DESCRIPTION

chapter 7|10 pages

HVAC DESCRIPTION

chapter 8|4 pages

UTILITIES DESCRIPTIONS

chapter 9|12 pages

VALIDATION PROGRAM OVERVIEW

ORGANIZATION

chapter 10|2 pages

CALIBRATION PROGRAM SUMMARY

chapter 11|2 pages

PREVENTIVE MAINTENANCE PROGRAM SUMMARY

chapter 12|2 pages

KEY STANDARD OPERATING PROCEDURES (SOPs)

chapter 13|2 pages

VALIDATION OF BUILDING

chapter 14|10 pages

VALIDATION OF UTILITY SYSTEMS

chapter 18|32 pages

QUALIFICATION OF PROCESS EQUIPMENT

chapter 19|8 pages

VALIDATION OF SUPPORT PROCESSES

chapter 21|6 pages

cGMP PROCEDURES AND PROGRAMS

chapter 22|2 pages

VALIDATION SCHEDULE

chapter 23|4 pages

DRAWINGS FOR ABC PHARMACEUTICAL PLANT