Navigating the New Landscape: PULSE series - Your Guide to Revised Schedule M Compliance

The pharmaceutical industry in India is on the cusp of a transformative era with the Revised Schedule M for Good Manufacturing Practices (GMP) coming into full force from January 2025. This change is set to redefine quality benchmarks, ensuring safer, higher-quality medicines for patients worldwide. However, with stricter norms and no extension in sight, compliance poses significant challenges, particularly for MSMEs, which constitute nearly 80% of the sector.

Of the 10,500 drug manufacturing units in India, only about 2,000 currently comply with WHO-GMP standards (Source). The new guidelines demand significant upgrades in infrastructure, processes, and systems, covering areas like product development reports, process validation, method validation, and post-marketing surveillance. Non-compliance risks not just operational shutdowns but also reputational damage and loss of market trust.

This means significant changes for manufacturers, especially those with annual turnovers below Rs 250 crore who have a 12-month window to adapt.

It's easy to feel overwhelmed. The new norms demand substantial investments in upgrading facilities, equipment, and processes. You're probably thinking, "Where do I even begin?"

That's where PULSE comes in. PULSE (Pharma Upgradation & Learning Series of Excellence), a comprehensive training series, has been meticulously designed to equip pharmaceutical professionals like you with the knowledge and skills needed to navigate the complex landscape of revised Schedule M compliance.

We've already covered the focused topics. Over the past 12 sessions, we've delved into critical areas like:

• Revised Schedule M - Overview and implementation plan.
• Pharmaceutical Quality System (PQS): Understanding the core elements of a robust quality system.
• Quality Risk Management (QRM): Identifying, assessing, and controlling risks throughout the drug lifecycle.
• Qualification and Validation: Ensuring your equipment and processes meet the highest standards.
• Water Systems & Qualification: Mastering the critical aspects of water quality control.
• HVAC Systems & Qualification: Understanding the importance of environmental controls in manufacturing.
• Personal Hygiene, Sanitation & Contamination Control: Minimizing contamination risks and ensuring product safety.
• Good Documentation Practices: Maintaining accurate and comprehensive documentation.
• Training and Assessment Program: Developing effective training programs for your workforce.
• Premises and Equipment: Creating a compliant and efficient manufacturing environment.
• Good Practices In Quality Control: Implementing effective quality control procedures.
• Complaints and Product Recall: Managing complaints and product recalls efficiently.

But the journey doesn't stop there. We're moving forward with 13 more sessions planned for 2025, diving deeper into the intricacies of the revised Schedule M guidelines. These sessions are essential for any professional seeking to ensure their organization's compliance and remain competitive in the evolving industry.

And here's the best part: The 13th session is completely free! This is your chance to experience PULSE firsthand and see how it can help you.

PULSE is backed by the support of key industry associations:

• Confederation of Indian Pharmaceutical Industry (CiPi)
• Laghu Udyog Bharati (LUB)
• Indian Pharma Machinery Manufacturers’ Association (IPMMA)
• Karnataka Drugs & Pharmaceuticals Manufacturers’ Association (KDPMA)
• Himachal Drug Manufacturers Association (HDMA)
• Federation of Madhya Pradesh Chamber of Commerce & Industry (FMPCCI)
• Drug Marketing & Manufacturing Association (DMMA)
• Rajasthan Pharmaceutical Manufacturers Association (RPMA)
• Pharmaceutical Manufacturers’ Association of Tamil Nadu
• Drug Manufacturers Association (DMA)

The future of the pharmaceutical industry lies in compliance. Join the PULSE series and equip yourself with the knowledge and skills to navigate the challenges ahead. Embrace the change, drive innovation, and ensure your organization is ready for the future.

Register for the free 13th session today!