Calibration Pharma Industry Importance

Calibration in Pharma Industry, Pharmaceuticals are active even in its micro gram concentration and give very great degree of impact on human body, for example hormones and antigens are very potent in their actions on human body, hence pharmaceutical dosages are required to meet their required standards while any point of manufacturing processes, hence the tools used to ascertain their standards must be calibrated to ensure the accuracy of the process and quantity.
Therefore USFDA mention in its guidelines that every system being validated must me validated with use of previously calibrated instruments.

Definition of calibration:

Calibration term is used with respect to instruments and equipment used in pharma industry.
Calibration can be defined as setting up a measure to a desired accuracy, and ensuring the set level of accuracy are meet on day today usage of an instrument or equipment, which can be verified by any other method available to validate the accuracy of measures to be carried out with the equipment or instrument or by challanging the reading with suitable mean and establishing accuracy of reading. More over a system should be available for validation of calibrated systems and calibration must be carried out by approved standard operative procedure, which state , the setting up of an instrument or equipment to its accuracy of measurement in event it gives results beyond desired set value. SOP must mention how to handle any deviation in the same.
It is very important in pharma industry that a drug being manufactured meets the required standard with respect to its content, purity, efficacy, and standards, performance for example sustained release dosage form must perform to its desired intended drug delivery level for the required for which it is assigned to deliver drug.
The accuracy of each and every measure must be very high so that a given drug meets its standards, even in the processes adapted in large scale continuous manufacturing processes.
Finally a drug product must meet its Standards,
Standards of a drug is a very big list which begins with the source of the raw and packaging material which would be used in manufacturing of a drug, and the parameters observed, processes being adapted, environment in which a drug product is manufactured, and finally the desired standards of a drug 1) Content 2) Uniformity of content 3) performance standards like, purity with respect to extraneous allowable matter, under limit, and dosage specific performance standards.
1) Calibration of weighing balances, in receiving, dispensing, issuing, manufacturing processes, and at all check points in Pharma manufacturing.
2) Calibration of volume measuring equipment’s, measuring cylinders, burretes , pipettes , manufacturing vessels ect.
3) Calibration of Pressure Gauges.
4) Calibration of temperature measuring instruments , electronic thermometers
5) Calibration of Mercury thermometers
6) Calibration of particle counter
7) Calibration of Analytical instruments, Calibration of UV visible spectrophotometer , Calibration of HPLC , calibration of physical property measuring instruments like , Viscometers, (brokefield Viscometers ) Ostwald viscometer, refractometer, Infrared spectrophotometer , Chromatography systems.
8) Calibration of equipments being used in pharma quality assurance system.
9) Calibration of computer systems.

There are few calibrating systems available in market which are known as documenting calibrators, which are instruments which can be used for calibration of wide range of instruments, and data from the same can be uploaded in computer systems and vice versa. We will be providing systematic and standard methods for calibration of all above.

Leave a Reply