Assessing the Regulatory Role of GMP audits for APIs

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Verma, Aayushi
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The pharmaceutical sector is crucial to global economics as well as the preservation and advancement of human wellness. For people to live healthier and longer lives, the industry closes the gap among their health and lifespan. Good manufacturing practices audits have been implemented to direct the behaviour and operations of Active Pharmaceutical Ingredients to protect the public's health and safety from phony, illegal, or tampered APIs. This research study has attempted to analyse the restrictions for APIs that have emerged inside the GMP sector in the pharmaceutical business. After conducting a literature search, the research's objectives were informed by the shortcomings in the field. These gaps include the significance of GMP audits for APIs, challenges, and implications in ensuring API quality, the extent to which regulatory authorities mitigate these issues, and the creation of a framework for the role of various regulatory authorities in standardizing GMP audits for APIs. Six participants were chosen for the analysis using the convenience sample approach, which is a type of exploratory design used in qualitative research. Zoom was used to start semi-structured interviews with the participants to get their qualitative information. The gathered qualitative responses were analysed using the Gioia qualitative data evaluation method. The study concluded with 1. the goal of GMP audits is to make sure that a facility is producing pharmaceuticals with efficacy, compliance, and continuous improvement. 2. Audits and manufacturers are facing challenges with complex supply chain, regulatory complexity, and counterfeiting. 3. The biggest implication of non-compliant APIs is patient safety. 4. Participants made recommendations as continuous improvement, corrective actions, and revalidation. Results demonstrate that the regulatory role of GMP audits for API in the pharmaceutical industry has enhanced the sector, yet there still exists a need for advancement and further growth if the sector is to compete with its counterparts in other regions of the developed world, particularly in the context of higher utilization of technology and enforcing of the legal regulations governing the sector. Academia scholars, authorities, pharmaceutical products, producers, buyers, and government agencies will all profit from the present research's input.

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