siliconindia | | AUGUST, 202519obligations, the industry is focusing on reducing paper usage through simplified documentation and automated, paperless manufacturing processes.To minimize waste, manufacturing should optimize solvent use and enhance handling procedures for rejected materials, allowing for reprocessing instead of destruction. Energy efficiency can be improved by utilizing alternative fuels, such as biomass, for boilers and exploring renewable energy sources like solar power. Additionally, packaging materials should be redesigned to decrease paper and plastic use through compact designs. Collaboration between the engineering and pharmaceutical industries can lead to the development of machinery that minimizes waste and employs biodegradable or bulk packaging solutions. Ultimately, the Quality Unit can serve as a change agent in implementing ESG initiatives while ensuring product quality and regulatory compliance. What best practices should companies adopt to prepare for regulatory audits, manage audit findings, and demonstrate a commitment to patient safety and continuous improvement in quality standards?To achieve success, it's crucial to be consistently prepared for inspections. This involves adhering to regulatory requirements, following written procedures, and ensuring comprehensive documentation right from the start of any activity, aligned with Data Integrity principles (ALCOA++). All manufacturing and testing records must be reviewed before a batch is released, and QMS documentation should be kept updated. Periodic reviews at all organizational levels, including top management, are necessary to maintain the manufacturing site's health.Even with strict adherence to systems and procedures, inspectional observations may occur. In such cases, voluntarily offering a Corrective and Preventive Action (CAPA) plan during the inspection can be beneficial if accepted by the inspector. If not accepted, the observation will be included in the inspection report.When responding to inspectional observations, it's important to thoroughly analyze the cited issues, consider the background, and develop a comprehensive CAPA that extends beyond the cited observation. Conduct an impact assessment related to product quality and patient safety, including additional testing if necessary. Responses to the regulatory agency must be timely and, although not all CAPAs need to be completed beforehand, they should demonstrate a holistic approach with justifiable timelines for implementation. Periodic follow-ups on CAPA progress are also recommended.According to GMP guidelines, self-inspections or internal audits should be conducted to ensure compliance and drive continuous improvement in the quality system
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