AN OVERVIEW OF CLEANING VALIDATION PART I WHAT

AN OVERVIEW OF CLEANING VALIDATION PART- I WHAT IS CLEANING VALIDATION? PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA, RANCHI 1

LEARNING OUTCOME • After watching this VIDEO lecture we are going to LEARN: • What is cleaning validation? • Importance of cleaning validation • Cleaning validation plan 2

CLEANING VALIDATION 3

WHAT IS CLEANING VALIDATION? • It is an documented evidence which provide high degree of assurance that an approved cleaning procedure will provide equipment that is suitable for processing of pharmaceutical products API 4

IMPORTANCE OF CLEANING VALIDATION 5

WHAT IS THE IMPORTANCE OF CLEANING VALIDATION? q. Heart of pharmaceutical activity. q. Related to safety & purity of products. q. Level of cleanliness is achieved by clean procedure which depends on its cleaning validation method if performed confidently, method reproducible results. 6

• Now, please take a pause for 2 minutes to recapitulate the topics we have discussed, and try to answer the following questions: 1) What is cleaning validation? 2) What is its importance? 7

CLEANING VALIDATION PLAN 8

WHAT ARE THE STEPS OF CLEANING VALIDATION PLAN? ØCleaning validation plan must define the following: 1)What is to be validated 2)How it is to be validated 3)Who is to validate it 4)Who is to approve the validation 5)When it must be revalidated 9

üIN THE NEXT VIDEO WE ARE GOING TO LEARN ABOUT • WHAT IS LEVEL OF CLEANING VALIDATION? • STAGES OF CLEANING VALIDATION 10

Prepared by: Mr. Rahul Brahma Mr. Sibajyoti Mukherjee Dr. Kishanta K. Pradhan Dr. Manik Ghosh PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA, RANCHI 11