Validation & Qualification in Pharma Facilities

Validation, calibration and qualification are extremely critical in pharmaceutical processes. Understanding them is necessary in order to meet cGMP guidelines.

By Edward Simpson, Calibration and Technical Engineer, RS Calibration

Pharmaceutical facilities consist of various processes, each of which must be accurate to ensure that the end product is of high quality. While validation is concerned mainly with processes, it is referred to as a qualification when the same approach is applied to a machine or equipment instead of a process.

Why is Validation Needed?
Validation is a systematic approach where it is confirmed that any process in a pharmaceutical facility will operate within the specified parameters whenever required. This is achieved by collecting and analyzing data. Validation is done to assure that the processes will produce consistent and repeatable results within the predetermined specifications.

Validation is needed as it verifies whether the quality standards and compliance are being met by the product in real time, which is really important in every pharmaceutical facility. Further, it also establishes that the facility is meeting current good manufacturing practice (cGMP) guidelines that are set for the industry by concerned regulatory bodies. Validation can be considered as a documented evidence of the process meeting the predetermined specifications.

Validation of IT Systems
No pharmaceutical plant is complete without an IT system, which is responsible for controlling, supporting and documenting various processes. It is extremely important to validate the computer and IT systems as it makes sure that all the concerned IT applications are fulfilling their intended purposes.

Validation helps in controlling different phases of development, design, testing and routine of the software that is being used by the IT system during its life cycle. As long as the computer system is running accurately, you can be assured that all the information and reports that they store remain safe. You must implement stringent quality requirements in GMP-regulated industries to control the procedures throughout the Software Development Life Cycle.

Focus the validation efforts on crucial aspects such as risk analysis and in-depth validation approach. Make sure that you apply the documentation to the computerized system as it manages crucial data that has an impact on the quality of the products. The components of computer system validation include all the activities that are involved in applying the appropriate controls throughout the SDLC and for procedures that are necessary for creating the documentation.

Why is Calibration Important?
To make sure that validation of processes is legitimate, you have to do calibration. It is a process which demonstrates that an instrument is producing results within the specified limits as compared to those produced by a traceable standard over an appropriate range of measurements. It is extremely crucial that all calibration activities are performed with qualified instruments by an accredited laboratory.

You must ensure that you always use calibrated instruments in manufacturing. Using uncalibrated instruments can lead to safety risks, which is an absolute no-no for any pharmaceutical company. You will see an increase in waste if you use uncalibrated instruments. Further, equipment of poor quality will cost you a lot of money too, putting a financial burden on your company. Calibrate your equipment periodically to ensure that the measurements and outputs achieved are accurate at all times without affecting the quality of the final product.

What is Analytical Instrument Qualification?
Before you conduct validation, you must complete the process of qualification. It is a systematic process that starts by the project phases of the installations, equipment and utilities. Analytical Instrumentation Qualification, also known as AIQ, is the documented process where a complex and sophisticated measurement device is demonstrated to be accurate, precise and selective enough for the intended analytical measurement. This is carried out to determine the sustainability and qualification of any instrument for the intended purpose.

Qualification is not limited to a validation process, but it is a part of it. It can be further divided into installation qualification (IQ), operation qualification (OQ) or performance qualification (PQ). Based on the operation and function of equipment, system or utility, you must make installation qualification and operation necessary. They should be monitored and calibrated periodically and they must be submitted to preventive maintenance. If you want to fulfill the GMP requirements for quality assurance of products, you must consider several factors such as infrastructure, equipments and raw materials. Make sure that the whole production process is controlled until the final product is released.

Since all the three processes, validation, calibration and qualification, are extremely critical in pharmaceutical processes, you must ensure that you have the right outsourcing partner to conduct them. When you have the correct partner by your side, you get vital assistance in maintaining GMP standards, while keeping the costs down. Look for important traits while choosing a partner, such as their quality management system, their ability meet all your requirements while containing the costs, response to fluctuating workloads, etc. Make sure you tie up with the partner who is right for your company, and there will be one less thing that you have to worry about.

Author Bio
Edward Simpson is a seasoned Calibration and Technical Engineer working for RS Calibration Inc. Edward has a knack for finding faults in machines and does not rest until they are rectified to perfection. He lives in Pleasanton, CA and can be contacted anytime for matters related to machines on his email edward@rscalibration.com. He also invites people to visit his company www.rscal.com to learn more about the type of calibration work he does.

 

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