Every sector involving the manufacture and production of goods incorporates a set of rules or standard procedures. The purpose of setting such standards is to manage the quality of the products manufactured. These standard procedures need to be met while manufacturing any product such as medicines, food, health drinks, cosmetics, and many more. If not met, the whole batch or lot manufactured is considered Out of Specification (OOS). Thus, the product is not released in the market and the whole batch is rejected. In order to have control over it, every manufacturing industry consists of an SOP (Standard Operating Procedure) which has every process mentioned in it. Along with it, parameters that need to be checked and specifications that determine if the product is eligible to be released in the market are mentioned too.
Pharmaceutical industries also have SOPs for regulating the manufacturing processes of their pharma products. Information on parameters involving chemical analyses and microbiological analyses of the raw goods, finished products, packaging products, etc., are all mentioned in it. Specifications such as minimum and maximum requirements of the chemical and microbial factors are as well described which would or else lead the product towards being ruled OOS. The question here lies – who governs these standards set in pharmaceutics manufacturing and production industries?
Quality Management System is a fundamental part of the pharmaceutical industry which regulates and governs if the finished goods comply with pharmacopeia standards set for the quality production of the pharmaceutical products. It is the main body that coordinates and monitors the manufacturing processes and implements regulatory requirements with the motive to ensure efficient and flawless production of pharmaceutical goods. It is an integration of two governing operations namely Quality Control and Quality Assurance.
Quality Control (QC): While a pharmaceutical product is being manufactured, ample things are to be taken care of.
All the analyses by the QC are conducted as per the industry protocol keeping in mind the pharmacopeia standards inscribed in the SOPs.
Quality Assurance (QA): Quality Assurance operations are of utmost cruciality in manufacturing industries like pharmaceutics. It is a focal point accountable for ensuring quality management.
It is critical to have QA and QC operating systems in the pharmaceutical industry. The purpose of having the same is the determination of the quality of the product being produced. Not only that, but its responsibility is to also determine the quality of the raw materials used during its production. Thus, without QA and QC bodies, drugs prepared in pharmaceutical industries would have no protocols to monitor their parameters. This would have led to degradation of product quality and thus a negative impact on the consumers. Consequently, it is pivotal to ensure proper QA and QC functioning to meet the quality requirements of the pharma products.
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