pi-006-3-mendation-on-validation-master-plan.pdf

PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 006-3 25 September 2007 PI 006-3 25 September 2007 MENDATIONS ON VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-STERILE PROCESS VALIDATION CLEANING VALIDATION ? PIC/S September 2007 Reproduction prohibited mercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. Editor: PIC/S Secretariat e-mail: info@ web site: 006-3 - i - 25 September 2007 TABLE OF CONTENTS Page 1. DOCUMENT HISTORY................................... ................................................ 1 2. INTRODUCTION....................................... ................................................... ... 1 Purpose of the document............................ ......................................... 1 Scope of the document.............................. .......................................... 1 Aims of Qualification and Validation............... ...................................... 2 Terminology........................................ ................................................. 2 When to qualify and validate ?..................... ........................................ 2 Change Control ..................................... .............................................. 3 Responsibility for Qualification and Validation .... ................................. 3 3. INTERRELATIONSHIP BETWEEN QUALIFICATION AND VALIDAT ION..... 4 4. VALIDATION MASTER PLAN............................. ........................................... 5 . Principle.......................................... ................................................... .. 5 Purpose............................................ ...................................................5 Definition ......................................... ............................................