An overview of the INTRODUCTION TO VALIDATION CALIBRATION

An overview of the INTRODUCTION TO VALIDATION , CALIBRATION, QUALIFICATION PART-1 What is VALIDATION & SCOPE of it PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA

LEARNING OUTCOME • After watching this Video lecture we are going to LEARN: • Definitions of calibration. • Definition of Qualification. • Definition of Validation. • Scope of validation. • Frequency of instrument calibration.

What is validation?

WHAT IS VALIDATION? Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines.

What IS CALIBRATION

What is Calibration? • This refers to the process where you can determine if an instrument or device is producing accurate results within the specified limits when it is compared to traceable standards of measurement. This is important for justifying the processes of Qualification and Validation.

What is Qualification

What is Qualification- • When the validation approach is related to a machine or equipment, rather than Validation, this is referred to as Qualification is part of, but not limited to, a validation process, which in turn can be divided into Installation Qualification (IQ), Operation Qualification (OQ), or Performance Qualification (PQ).

• Now, please take a pause for 2 minutes to recapitulate the topics we have discussed, and try to answer the following questions: • What is validation? • What is calibration? • What is qualification?

SCOPE&FREQUENCY OF VALIDATION

SCOPE&FREQUENCY OF VALIDATION • validation requires an appropriate and sufficient infrastructure including – organisation, documentation, personnel and finances. • Involvement of management and quality assurance of personnel. • Personnel with appropriate qualification and experience. • Extensive preparation and planning before validation is performed. • Validation should be performed. • For new promises , equipments and system and process and procedures at periodic intervals and when major changes have been made.

Continued. . . • Validation in accordance with written protocols. • Validation over a period of time e. g. atleast three consecutive batches to demonstrate consistency. • Significant changes ( facilities, equipment, process) – should be validated. • Risk assessment approach used to determine the scope and extent of validation needed.

Frequency of instrument calibration • How often the instrument should be calibrated mainly depends on its tendency to drift from the true measurements and how it impacts the quality of the end product. • Behaviour of each instrument being used are studied and examined. • Based on this information one can design a calibration schedule for each instrument. The interval between calibrations can vary as - weekly -monthly or bi-monthly -Quarterly, semi-annually or annually. - After heavy usage of the instrument.

• IN THE NEXT VIDEO WE ARE GOING TO LEARN ABOUT • Difference between validation & calibration ? • Advantages of validation?

Prepared by: Ms. Aditi Roy Dr. Kishanta K. Pradhan Dr. Manik Ghosh PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA