Importance of Quality Control Process in Pharmaceutical Industry in India
We cannot stress enough the importance of the Quality Control Process in the Pharmaceutical Industry in India. Pharmaceutical medicine must be marketed when it passes all the rigorous quality tests. In addition, it should be clinically appropriate, safe to use, and therapeutically active formulations with predictable performance. In other words, before sending any medication for consumption in the market, they need approval and tests. To sum up, one can’t ignore the importance of the Quality Control Process in the Pharmaceutical Industry in India.
However, we can understand it thoroughly. In brief, every medicine produced needs to be tested and approved for consumption by higher authorities and concerned laboratories. After that, they can be sold and consumed by the masses. Today, we will cover some topics on how these topics and processes work. Also, we will discuss various functions in the Quality Control Process in the Pharmaceutical Industry in India. Read on.
Compromising on the quality of pharma medicines is equal to risking the life of humans. Quality plays a vital role in the Indian pharma industry. In addition, if the pharma company negotiates on the quality, it loses credibility. Every pharma company has a quality control department to ensure the precise production of pharma medicines. Also, higher product quality solidifies the position of a brand in the pharma marketplace.
Below Points Shows the Importance of the Quality Control Process:-
- Quality control is a sign of trust, purity, efficacy, reliability, and effectiveness of the manufactured medicines.
- The quality control department and quality control process are necessary to meet the set quality standards.
- This process helps pharma companies produce high-quality medicines and people avoid undesirable side effects.
- Pharma companies cannot convince consumers to buy their products if their medicines don’t bear certification of authenticity.
- All above, the quality control process in the product helps pharma companies avoid legal issues, financial loss, and penalities.
So, not only for consumers but for pharma companies quality control process is important in the pharmaceutical industry. Pharma companies should not avoid it at any cost. Without proper quality control methods, a pharma company cannot grow or establish itself in the market.
Research and Analysis Areas in Pharmaceutical Industry
The Indian pharmaceutical industry produces, develops, and markets medications with the sheer responsibility of human healthcare. Ignoring quality concerns in pharmaceuticals is equal to risking consumers’ life. In short, quality in pharma is directly connected with humans. Therefore, the pharma companies aim to deliver zero-defect products with high efficacy, and safety. For this purpose, pharma medicines need to be tested in several areas and the main research and analysis areas are as follows:-
- Microbiological Laboratory
- Packaging Material Laboratory
- Physical-Chemical Laboratory
- Process Control Laboratory
In addition, every country has its own set of essential rules and regulations also to ensure precise production and quality control. Concerned must follow the rules while governing processes and should have the proper production authorization. Also, there are internal and external audits to ensure the rules and laws are being applied and followed correctly.
The function of QMS in the Production | Pharmaceutical Industry
Testing and verifying pharma medicines against predefined standards is the main function of the quality control department. Hence, the quality control department becomes a vital part of pharmaceutical medicine production. Without it, a pharma company cannot carry out production. More functions of the QC department in the pharmaceutical industry are listed below.
- Sampling, inspection & testing of Raw material
- Inspection, Sampling, & testing of packaging material
- Testing, sampling, inspection & of in-process product
- Final products sampling, inspection & testing
- Release/rejection of batch for sale
As stated above, the quality control department functions for assuring the quality of batches manufactured at every stage of manufacturing the drug. They play a vital role in delivering high-quality pharma medicines to patients and clients.
Elements of QMS (Quality Management System) in Pharmaceuticals
Those Pharma companies who don’t follow good manufacturing practices, ISO, standards, and guidelines, leave themselves open to making mistakes, errors, and incurring penalties from the FDA. For quality assurance, a pharma company needs a quality management system that promotes a customer-focused culture. Also, the quality management system should have the following elements.
- Customer focus
- Process approach
- People involvement
- Continual improvement
- Factual approach to decision making
- Mutually beneficial supplier relations
- A systematic approach to management
On the Final Note
This blog addresses the Importance of the Quality Control Process in the Pharmaceutical Industry in India. We hope that this information was helpful and you got here what you were searching for. Also, you might have understood the importance of quality control, QC department, and QMS. Aside from that, if you are an entrepreneur who wants to enter the pharmaceutical space, then you are still at a valid place. Saphnix Lifesciences offer PCD pharma franchise services throughout the nation at pocket-friendly prices. Contact us now!