Pan Asian Clinical Research Association (PACRA)

Why is Quality Assurance Critical in the Pharmaceutical Industry

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The importance of calibration in the pharmaceutical industry has been discussed a number of times. Calibration assures that the quality and consistency of every single product is maintained. The pharmaceutical industry needs to ensure that every product shipped out of their facility is of the highest quality as even one bad batch can put numerous lives at risk. At the same time, the company’s reputation will take a massive hit. This is why Quality Assurance is critical to the pharmaceutical industry.

Quality Assurance (QA) is a method used in the development of services and products to ensure a high level of quality in production. It encompasses various processes and procedures that help monitor different aspects of a service, process or facility in a systematic manner to detect and correct problems or variances that fall outside the established standards or requirements.

It is an integral part of GMPs (Good Manufacturing Practices) in almost every pharmaceutical and bio-tech industry and it helps you vouch for the integrity of any product that it meets the required standard for the proposed use. With QA, the end-user can be assured that the manufacturer meets the needs with respect to safety, reliability, efficacy, strength, and durability, apart from quality, which is a benchmark of perfection for the end-user.

Why Do You Need QA

There are four main objectives of Quality Assurance:

  • It offers a guarantee to whoever is administering the medicine that they can be confident that it has been produced to the highest quality and safety standards.
  • With Quality Assurance, you can make sure that all the necessary laws and regulations are in compliance
  • It helps in protecting the manufacturing company against any kind of potential losses, penalties or negative publicity that may be caused due bad quality of the product.
  • It helps to protect all users against potential accidents and defects in manufacturing, design and usage instructions.

QA – The Nucleus of Quality System in Pharma

Quality assurance is responsible for forming the base of a quality system of any pharmaceutical company. However, a number of other elements are taken care of by the quality assurance unit and they are implemented through a networked organization that incorporates specialized departments. They may be handled under the umbrella of other functions.

You can achieve this by executing through a quality assurance department as a global function that has a direct line to the senior management or executive level. Thus, quality assurance can emphasize on providing suitable systems and defining them in SOPs and higher level instructions when appropriate information is provided.

In short, you can say that QA unit’s sole responsibility is the formation of the pharmaceutical quality system. Generally, it is independent of the production processes. If you want to deal anything with quality assurance, it goes through a QA department.

Helps You Certify the Quality of any Product

You can understand and shape the function of quality assurance department while placing emphasis on the operational aspects. This helps in appreciating the role of quality assurance personnel, which includes data preparation for the Qualified Person so that they can release a batch of any product and certify its quality.

The quality assurance unit will then generate portions of batch-related data to make sure that they are available through appropriate reporting systems. Apart from that, they will also guarantee the functionality of standard quality systems. There is a hierarchical equivalency between quality assurance, quality control and heads of production and all three of them divide the labor amongst themselves.

Ensures Product Safety and Reduces Liability

Instrument calibration ensures that all the instruments involved in manufacturing are giving accurate measurements, which further helps in producing high quality products. Strict product liability is becoming the norm in almost every manufacturing company. This is further heightened as new product liability legislations are introduced within the developed world. This effects the industry as businesses need to continue trading profitably to take safety oriented procedures into account. Quality assurance helps in keeping the product liability risks at a minimum.

Quality assurance lets you validate the quality of every product. It is important that you comply with FDA guidelines (in the US, or your own country’s regulatory body elsewhere in the world) to improve your product liability. Make it an important part of every process in your organization.

 Author Bio: Edward Simpson is a seasoned Calibration and Technical Engineer working for RS Calibration Services. 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. He also invites people to visit his company to learn more about the type of calibration work he does.


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