Role of regulatory affairs in ensuring quality and safety of pharmaceutical products
Keywords:
Pharmaceutical Industries, Commercial Organisations, Regulatory Affair, PLM System, Robust Management Systems, Medicinal Products, Quality Control, FDA and EMAAbstract
Strong quality control and monitoring procedures are essential for the integrity of the pharmaceutical business because they guarantee the efficacy and safety of pharmaceuticals. This study examines the legal framework that controls these activities, providing insight into the constantly shifting atmosphere that organizations like the FDA and EMA have built. All commercial organizations are now required to implement a PLM system. Businesses must adhere to the various available suggestions for implementation to guarantee the effective implementation of a PLM system solution. Regulatory Obstacles: Stringent laws and changing standards can cause approvals to be delayed, development costs to rise, and new medicine availability to be restricted. Manufacturing Problems: The integrity, effectiveness, and safety of pharmaceutical goods can be jeopardized by variations in manufacturing, supply chain disruptions, and quality control failures. Pressures from Competition: Share of the market and profitability can be severely impacted by fierce competition from biosimilar, generic medications, and cutting-edge treatments, particularly for goods with little point of differentiation. Safety Issues Following the Market: Recalls, legal action, and reputational harm to the company could happen from adverse events, medication interactions, and long-term negative effects that are identified after a product is launched. Pharmaceutical firms can reduce risks, improve the quality of their products, and enhance the likelihood of achievement throughout the product life cycle by being aware of and taking proactive measures to address these factors.
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