An Overview of Calibration

Any biologically related industry produces varying products which target the lives of biological species that are present on Earth. Any minute mistake can affect their lives but it can be avoided by the correct implementation of regulators because they ensure the safety and integrity of all the processes which are involved in pharmaceutical analysis. All these regulators are highly adopted in pharmaceutical companies. Manufacturing of pharmaceutical products is done in batches possessing high volume. The measurements of pharmaceutical products are done by autoclave. Flowmeters also play an important role in weighing by implementing the addition of materials. 

Why Carry Out Calibration? 

• As we know that the most important thing is to provide a good quality of products to ensure the process measurement is mandatory otherwise it can be critical to mankind’s consumption
• Calibration of instruments is done from time to time as it ensures that the production of a pharmaceutical product is done properly
• Before the production of pharmaceutical products, it is mandatory to verify that the process of calibration has been done accurately. This verification process is known as calibration documentation. This verification is helpful to catch the problem and error that has occurred in the product
• In ancient times the term calibration was used to generate a trial done on papers to gather the information regarding product production’s date, time, equipment of testing and so on

It is mandatory to carry out calibration according to the written guidelines provided by the government and it must be recorded timely for further analysis

Electronic documentation can be defined as the process of documentation in databases that can be easily accessed and used. 

Characteristics of Electronic Documentation

• Electronic documentation takes less time
• It is less prone to documentation done manually on paper
• It is more accurate 

Beamex calibrators are portable calibrators designed for hazardous conditions and are used virtually. 

• Beamex calibrators are present in almost all pharmaceutical plants
• They use beam software and are regulated under the guidelines of 21 CFR
• Beamex calibrators make the process of calibration and documentation easy

While doing calibration it should be ensured that we can recalibrate the instrument over a while in the future. ISO17025 and ISO10012 are two international standards that are required to carry out calibration programs. 

ISO17025: The strictest method of calibration.

Requires a measurement report with all the details of the measurements.

Some Key Terms to Be Kept in Mind for Pharmaceutical Analysis

• Uncertainty of the pharmaceutical device to the customers must be evaluated and specified so that it cannot create a problem in the future. Because these devices are very expensive, it is better to recalibrate them than to purchase them now
• The stability history of the Calibrator for Pharmaceutical analysis is the most important criterion so that the customer can carry out the calibration management without more fluctuations in the device
• The initial calibration period of the calibrator must be shorter for initial times
• Apart from these environmental conditions, the amount required for transportation, and workload should be considered
• Calibrators are used worldwide by the pharmaceutical companies some of the companies are listed below:
• Eli Lilly and Company Limited, this company uses approx 11,000 calibrators in a year which are designed mostly with Beamex calibration equipment
• This pharmaceutical company is one of the largest companies worldwide and is known for manufacturing various healthcare solutions
• They mostly do their investments in their instruments, their control systems, and testing of the equipment to achieve the high standard of demands
• Calibration in Food Industries must be done accurately to avoid issues that can prove bad for health because Legal action can be taken against the company, EHO which is abbreviated as Environmental Health Officer can notice the company for closure and Hazard Analysis Critical Control Points, HACCP, and customers being ill

What is the purpose of Calibration? 

Calibration is done to achieve:

• Accuracy
• Precision
•  Reliability
•  Deviations in the measurements of all other pharmaceuticals 
• For the establishment of the reliability of the pharmaceutical instruments that are used in the pharmaceutical companies from time to time in a repeated manner
• To find out the inaccurate date which is listed as documented
• cGMP abbreviated as current good manufacturing practice is used to ensure the standards of the pharmaceutical company

How Frequently Do We Have to Calibrate the Pharmaceutical Instrument? 

Depending upon drift or fluctuations of the true and accurate measurements pharmaceutical calibrations can vary and can be scheduled at the following time intervals basis, so it can be carried out:

• Weekly, Monthly or bi-monthly, Quarterly, semi-annually, or annually basis or it can be done at any time without waiting for the scheduled time if found any false changes

When shall the Measuring Instruments have to be Calibrated?

• The frequency with which measuring equipment is calibrated is determined by numerous factors. The following is a list of situations in which equipment should be calibrated as part of good manufacturing practices:
• Before you test out a new instrument, you should calibrate it as quickly as possible.
• Take key measures both before and after
• Any time there has been an electrical or mechanical shock, or a similar occurrence such as a tumble, bump, etc. Calibration must be followed by a safety check if there is an electrical surge
• When you have concerns about the accuracy of the measurements being taken
• If the instrument needed any repairs or requalifications
• According to criticality requirements or as part of a calibration plan
• Depending on the task and process, some may require calibration before beginning work
• Following the manufacturer’s instructions

Methods and Procedures Used to Carry Out Pharmaceutical Calibration

Calibration of an instrument is done according to the FDA guidelines. 

Standard Calibration

• The highly preferred method for calibrating instruments of a pharmaceutical company
• They are non-critical to quality
• They don’t require any government accreditation or licence

Calibration with Data

• They don’t accompany data on measurement uncertainties

Conclusion

A calibration is an act of checking the working efficacy of a device or equipment. Calibration provides accreditation services that provide trust to the fellow mates who carry out the calibration process as it ensures the quality of the product produced by the companies for the welfare of humankind.