REQUIREMENT OF CALIBRATION ITS PREVENTIVE MAINTENANCE PART1 REQUIREMENT

REQUIREMENT OF CALIBRATION & IT’S PREVENTIVE MAINTENANCE PART-1 REQUIREMENT OF CALIBRATION 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: • WHAT IS CALIBRATION? • WHAT IS PREVENTIVE MAINTENANCE? • REQUIREMENTS OF THE REGULATION AUTHORITY TO BE FOLLOWED • CALIBRATION REQUIRED IN THE MANUFACTURING AREA • INSTRUMENT IDENTIFICATION AND CALIBRATION STATUS • STEPS TO IDENTIFY A INSTRUMENT AND CALIBRATION • TOLERANCE LEVELS IN CALIBRATION

INTRODUCTION

INTRODUCTION • Regulatory authorities like FDA ensures that all the firms have calibration and preventive measures for all the measuring equipment. • Preventive maintenance program is one of the most important aspect of GMP inspection which ensures the equipment are operating according to the GMP regulations. • Any equipment operated will perform functions properly either for manufacturing, packaging, labelling or holding of drug products is mandatory to be calibrated, inspected and checked for errors according to the regulations which are designed to assure best performance of the equipment.

WHAT IS CALIBRATION?

WHAT IS CALIBRATION? • Calibration is a set of operation when performed under specific conditions of a particular instrument and the results obtained from that instrument is compared with the results obtained from another instrument which give results of results within accuracy standard. • By calibration, we can eliminate any problem that arises in the accuracy of instruments or measuring devices when compared to standards.

WHAT IS PREVENTIVE MAINTENANCE?

WHAT IS PREVENTIVE MAINTENANCE? • It is referred to as the regular service provided by the personnel to ensure that the equipment is working under satisfactory conditions by regular inspection, detection and correction of failures before even any problem arises. • This ensures that the equipment is in proper working conditions and it also extends the life of the instrument.

REQUIREMENTS OF THE REGULATION AUTHORITY TO BE FOLLOWED:

REQUIREMENTS OF THE REGULATION AUTHORITY TO BE FOLLOWED: • Calibration programme is required to follow the regulatory authorities under 21 CFR part 211. 68 and preventive maintenance of calibration programme for laboratory instruments by FDA under Section 21 CFR part 211. 67.

CALIBRATION REQUIRED IN THE MANUFACTURING AREA

CALIBRATION REQUIRED IN THE MANUFACTURING AREA • FDA ensures that each manufacturing area has a written different calibration and written preventive maintenance procedures. • They must contain qualified personnel to calibrate and maintain the equipment and another personnel to recheck. • They have one representative to monitor the calibration and preventive maintenance programme. • This whole process of calibration and preventive maintenance is approved and reviewed according to the type of quality products that is produced.

• Now, please take a pause for 2 minutes to recapitulate the topics we have discussed, and try to answer the following questions:

INSTRUMENT IDENTIFICATION AND CALIBRATION STATUS

INSTRUMENT IDENTIFICATION AND CALIBRATION STATUS • There are certain steps in the calibration and preventive maintenance programme to identify the instrument. • Instruments are termed according to the terms of criticality. Some of the instruments are critical and some are non critical. Some have effects on environment so are identified as environmental critical instrument. • Some as direct impact on product quality known as GMP critical instrument.

STEPS TO IDENTIFY A INSTRUMENT AND CALIBRATION :

STEPS TO IDENTIFY A INSTRUMENT AND CALIBRATION IS: • Find out the given unique identification number and label the instrument with that number. • Details for instrument (model number, serial number, location) are available and documented. • Calibration history of the instrument must be documented. (model number, date of next calibration, details of person who is performing calibration). • There should be a system to identify a non calibrated system who has expired their calibration period to minimize the errors and maintain quality.

TOLERANCE LEVELS IN CALIBRATION

TOLERANCE LEVELS IN CALIBRATION • The tolerance of the reference standard is higher than the other equipment which is going to be calibrated. • Two types of tolerance level in calibration are there: • Alert level: Up to this level the instrument can be adjusted to it’s required range. • Action level: It’s known as out of the tolerance limit. At this level investigation is required for because we can’t make any adjustment at this level. If tolerance is between the Alert and Action level than that’s fine and the investigation is not required.

• IN THE NEXT VIDEO WE ARE GOING TO LEARN ABOUT • PREVENTIVE MAINTENANCE AND HOW IT IS DOCUMENTED AND USEFUL IN PHARMACEUTICAL INDUSTRY

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