Paper Key : IRJ************038
Author: Vivek Kumar,Atul Kumar Pandey,Dr.tarkeshwar Prasad Shukla
Date Published: 13 Apr 2025
Abstract
Quality Assurance (QA) in the pharmaceutical industry is essential to ensure that drugs are manufactured and distributed in compliance with regulatory standards, ensuring their safety, efficacy, and quality. The steps involved in QA are critical in safeguarding public health and maintaining industry credibility. The first step in QA is the establishment of quality standards, which include setting specifications for raw materials, in-process controls, and final product quality. Following this, raw material selection and supplier qualification play a pivotal role in ensuring that the ingredients used meet the required quality parameters. Manufacturing processes must adhere to Good Manufacturing Practices (GMP) and standard operating procedures (SOPs), with continuous monitoring and documentation throughout production. Regular in-process testing of critical parameters ensures that products meet the required specifications at each stage. Once the product is manufactured, comprehensive quality control (QC) testing is carried out to assess its identity, purity, potency, and stability. Any deviations from established standards are investigated through corrective and preventive actions (CAPA). The final step involves proper storage, distribution, and post-market surveillance to guarantee that products maintain their integrity until they reach consumers. This process ensures that the pharmaceutical products are safe for consumption, meet regulatory standards, and are effective in treating patients, thereby fostering trust in the healthcare system. Effective QA systems are thus a cornerstone in the pharmaceutical industry to guarantee patient safety and product quality.
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