Quality control is a significant operation of the pharmaceutical industry. In any pharma company quality control is one of the key departments. The pharma industry consists of a vital segment of health care by bringing life maintaining and life-restoring products. Quality control is more essential when using radiopharmaceuticals. Modern medicines for humans are required to meet exact standards which relate to their quality and efficacy. The evaluation of efficacy and safety and their Maintainance in practice is dependent upon the usage of adequate methods for quality control.
The pharmaceutical companies are strictly said to follow the government regulations regarding quality control. The pharma companies that work inappropriately as a manufacturer of drugs are not legally bound to follow the federal drug manufacturing regulations. Instead, they function under more easy-going policies that govern their operation but do not follow quality control analysis. This lack of regulation has led to several essential microbial outbreaks that have further resulted in multiple deaths. These events highlight the importance of effective pharmaceutical strict quality guidelines as well as the need for updated regulatory control.
Well, In this blog we Saphnix Lifesciences the leading third party manufacturing company will discuss the importance of quality control in the pharmaceutical industry.
Overview of Quality Assurance in Pharmaceutical Industry
The surge of standard and adultered medicine is a global threat. After the 1957 thalidomide disaster, the pharmaceutical industry saw an increase in regulation. The scientific, systematic, stringent and sustainable approach to commercial drug production ensures the protection of consumers health.
The practice control measures in the pharma industry that is also referred to as Standard operating procedures (SOPs) that are designed by regulatory authorities to ensure good manufacturing practice.
Role of Quality Assurance in the Pharma Industry
Quality assurance is a broad concept that includes all the aspects that individually impact the quality of the product. It is a good practice in the manufacture of pharmaceutical products as it is the process of the integrity of products to meet the standards for quality production. It is the obligation that ensures manufacturers meet the requirement of customers in terms of safety, quality, reliability, strength, and efficiency.
Quality Policies Followed by Pharmaceutical Manufacturing Companies
Pharma Manufacturing Companies are registered and government-licensed that manufacture and supply drugs. To make sure the sterility of pharma medications, various quality control methods are undertaken, including operation under GMP (Good Manufacturing Practices), product addition with antimicrobial preservatives and chemical testing. When the quality policies are properly followed, it prevents product adulteration and microbial contamination.
Food and Drug Association (FDA) and cGMPs are followed by all the pharmaceutical manufacturing companies. They are considered to assure the proper design, supervision, and control of all the manufacturing procedures to ensure the quality and sterility of products. This includes establishing a great management system, obtaining superlative raw materials, identifying product deficiency and maintaining laboratories.
Objectives of Quality Assurance
Quality assurance serves the number of objectives given below:
- To provide a guarantee that the person who is supervising medicine is confident that every unit will achieve the desired effect.
- To protect users from the possible accidental defects in manufacturing, designing, and storage.
- To provide protection of the manufacturing company.
- To make sure the law is complied with to the latter.
To sum up we can say that it is the responsibility of each pharmaceutical company to produce the pharma products of confirmed sterility. At present, the leading pharma companies operate under strict FDA regulatory control. Today the patients are served with effective regulations, procedures, updated and robust manufacturing, and quality practiced products.