From Compliance to Innovation: Transforming Pharma Premises and Equipment

On December 1, 2024, the 10th session of the PULSE Series, a collaborative initiative by the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy, convened pharma professionals to explore the vital aspects of Premises and Equipment in pharmaceutical manufacturing. This session focused on the design, maintenance, and compliance of facilities and equipment, aligning with global best practices and the Revised Schedule M.

The session was yet another milestone in the journey of fostering excellence, quality, and compliance in the pharmaceutical industry.

The Cornerstone of Compliance: Premises and Equipment

In pharmaceutical manufacturing, the design and maintenance of premises and equipment are foundational to ensuring product quality, safety, and compliance. The Revised Schedule M provides clear guidelines to help organizations optimize their infrastructure while maintaining regulatory adherence.

This session offered attendees valuable insights into:

• Implementing infrastructure designs that promote quality and efficiency.
• Ensuring compliance with regulatory requirements for premises and equipment.
• Addressing challenges in facility and equipment management.
• Leveraging innovation to enhance operational excellence.

Session Highlights

Keynote Address:

Dr Ashok Kumar Bhattacharya, PhD ( HC ) , MLE Harvard Square , Global Health & Pharma Consultant and Former Executive Director of Takeda India, delivered an engaging keynote that emphasized the importance of robust infrastructure in ensuring GMP compliance and operational success. He highlighted that premises and equipment are not merely physical assets but strategic enablers of quality and innovation. Dr. Ashok Bhattacharya urged organizations to view infrastructure as a competitive advantage and invest in designs that prioritize safety, efficiency, and sustainability.

Dr. Govind S. Pandey , CEO & Managing Director of GAMP Technologies Pvt. Ltd. and Director of Kopran Ltd., led the session with practical insights on optimizing infrastructure for compliance. Dr. Govind Pandey stressed the importance of adopting a lifecycle approach to facility and equipment management, integrating regulatory requirements at every stage - from design to operation. He also highlighted that maintaining compliance is not a one-time activity but a continuous process that demands proactive planning and innovation.

Panel Discussion and Open Q&A:

A distinguished panel, including:

• Dr. Govind Pandey
• Dr Deepak Haldankar , COO at H&H Healthcare and Cosmetics Pvt. Ltd.
• Mr. Subhrangshu Chaudhury , Vice President & Head of Quality at Centaur Pharmaceuticals Pvt. Ltd.

The panel shared practical approaches for designing, maintaining, and upgrading pharmaceutical infrastructure. They emphasized the need for collaboration between engineering, quality, and operations teams to ensure seamless compliance. During the interactive Q&A, participants received actionable advice on overcoming challenges in facility management and implementing sustainable solutions.

The session was Moderated by Mr. Harish Jain Manawat (President FOPE, Director Embiotic Laboratories)

Closing Remarks:

Mr. Arjun Kapoor , Additional General Secretary of FOPE, expressed his gratitude to the speakers, panelists, and participants for their invaluable contributions. He highlighted the importance of continued collaboration and learning to drive the industry forward.

Key Takeaways

1. Premises and equipment play a critical role in ensuring GMP compliance and product quality.
2. A lifecycle approach to facility and equipment management is essential for sustainable operations.
3. Collaboration between cross-functional teams is key to successful infrastructure implementation.
4. The Revised Schedule M provides a comprehensive framework for aligning infrastructure with regulatory standards.

Next in the PULSE Series: Session 11

The journey continues with Session 11, scheduled for December 15, 2024, focusing on Good Practices in Quality Control. This session will dive into the methodologies and strategies for maintaining quality standards in pharmaceutical operations.

Advancing Pharma through Knowledge Sharing

Session 10 demonstrated the power of collaboration and shared learning in addressing the critical role of infrastructure in pharmaceutical manufacturing. By empowering professionals with the tools to optimize premises and equipment, the PULSE Series is driving the industry towards greater compliance, quality, and operational excellence.

We extend our heartfelt gratitude to all the speakers, panelists, and attendees for making this session a success. Together, let’s continue building a future where excellence is the standard in pharma.

Stay Connected! Enroll Now https://events.pharmastate.academy/pulse-learn-revised-schedule-m-for-pharma-manufacturing-and-quality/

Together, we can elevate the pharmaceutical industry!