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Indian pharma assertive to chalk out pathway for revised Schedule M compliance without compromise
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Nandita Vijayasimha, Bengaluru
June 26 , 2025
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In a global pharmaceutical landscape that demands quality and trust, Indian pharma needs to adopt a zero-tolerance stance towards GMP noncompliance. This is not just a regulatory obligation but a strategic imperative. By propelling the pace of continuous improvement into every layer of operations, the industry can position itself as a global leader in manufacturing excellence, safety and reliability, said Mahantesh Wali, head, regulatory affairs, Maiva Pharma.
Noting that the industry needs to go beyond compliance to build excellence, Wali said it is here a comprehensive readiness for audit with compliance adherence will be only possible with the qualified workforce, upgraded facility, efficient processes and transparent records.
There is a need for continuous improvement to build excellence in preparing for audits and inspections, pointed out Wali at the recently concluded event of IPA Mysuru on Pharmaceutical Quality Assurance through GMP at the session on Revamped Pharmaceutical Technology Up gradation Assistance Scheme (RPTUAS).
For pharmaceutical manufacturing, quality metrics are an objective way to measure, evaluate, and monitor the product and process lifecycle. Quality metrics data may lead to higher levels of safety, efficacy, delivery, and performance. It assists in developing compliance, improves prediction and possibly mitigation of future drug shortages, while encouraging the pharmaceutical industry to implement innovative quality management systems for manufacturing, he said.
Digital tools like artificial intelligence (AI) Internet of Things (IoT) and blockchain across various domain helps to accelerate GMP compliance. Like for instance, use of software application in quality management system, LIMS to name a few, helps in the integration of critical and major equipment of production and quality control instruments to achieve 21 CFR part 11 compliance, said Wali.
The deadline for the revised Schedule M for large manufacturers was June 28, 2024 and the MSMEs (micro small and medium enterprises) deadline is December 31, 2025. We see that early adoption and concurrent implementation of global harmonization efforts like ICH, PIC/S will have a significant impact on the quality of products manufactured, he said.
The future outlook for the pharma is sustainability, agility, and regulatory evolution. Hence the key factor to implement GMP quality systems will enforce a quality culture of companies. Having zero tolerance towards noncompliance has to be adhered across the organization. This is because quality first leads to safe products for the public health. Workforce across the departments and the management must be swift in evolving GMP standards and integrating the technology in all the functions. It is also the role of regulatory affairs professionals in the company to communicate the audit scope and facilitate the process for adherence to GMP, said Wali.
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TOPICS
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Shanghai-based Hualian Pharmaceutical Machinery Company Limited, a family-run enterprise with roots going back to 1986, ...
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