PULSE Series Advances Knowledge on Water Systems & Qualification in Pharmaceutical Manufacturing

We are pleased to share the success of the latest session from PharmaState Academy's ongoing PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, conducted in association with the Federation of Pharma Entrepreneurs (FOPE). This year-long series, designed to enhance industry expertise on the Revised Schedule M, continues to serve as a vital platform for professional development within the pharmaceutical sector.

The 5th session, held on September 22, 2024, focused on Water Systems & Qualification-a critical component of pharmaceutical manufacturing. The event attracted over 180 attendees, reaffirming the series' role in providing professionals with essential regulatory insights and best practices.

Water Systems & Qualification: Key Takeaways

The session commenced with a keynote address by Dr. Manish Kapoor, Drugs Controller of Himachal Pradesh, who emphasized the pivotal role water systems play in ensuring pharmaceutical product quality. Dr. Kapoor lauded the PULSE initiative for concentrating on this critical area and underscored the significance of compliance with the Revised Schedule M.

Expert-Led Insights

The session featured an in-depth presentation by Mr. Shoeb Kurawadwala, Founder & Managing Director of CN Water, a recognized authority on Water for Pharmaceutical Purposes. Mr. Kurawadwala provided a comprehensive overview, covering several essential topics, including:

1. System Design & Maintenance: The need for well-designed, rigorously maintained water systems to produce high-quality water consistently, with continuous monitoring for chemical, microbiological, and endotoxin contamination.
2. Ongoing Qualification & Validation: The importance of viewing qualification and validation as continuous processes, supported by regular reviews to ensure system reliability.
3. Risk Management: How proper design, installation, and maintenance of water systems, combined with routine sanitization, reduce the risk of microbial contamination.
4. Water Grades: The necessity of managing Purified Water (PW) and Water for Injection (WFI) to meet the specific requirements of various manufacturing processes, aligning them with international standards.

The practical guidance offered by Mr. Kurawadwala provided attendees with actionable strategies for ensuring compliance and maintaining operational excellence in water system management.

Panel Discussion & Q&A

Following the presentation, an expert panel discussion-moderated by Mr. Harish Jain, President of FOPE - offered further valuable insights into water system design and qualification strategies. Panelists included:

• Mr. Shoeb Kurawadwala, Founder & Managing Director, CN Water
• Dr. Sanjit Singh Lamba, Managing Partner, Trillyum Consulting
• Mr. Rajesh Madan, CEO, Medicamen Biotech Limited
• Mr. Manojkumar Singh, Founder, Maanvi Ecotech

These distinguished professionals shared their experiences and expertise on risk-based approaches, cost-efficient solutions, and regulatory compliance, addressing practical challenges faced by the industry.

An interactive Q&A session allowed participants to engage directly with the experts, exploring critical topics such as microbial risk mitigation and requalification after facility upgrades. The panel offered valuable guidance on requalification strategies, the cost-efficiency of investing in high-quality water systems, and the importance of maintaining data integrity and change control.

Call to Join Upcoming Sessions

We extend our heartfelt thanks to all participants, speakers, and panelists for their contributions to the success of this session. As we continue the PULSE series, we invite industry professionals to join us for the next session, scheduled for October 6, 2024, which will focus on HVAC Systems & Qualification.

With the demand for practical, compliance-driven knowledge steadily increasing, the PULSE series remains an invaluable resource for those seeking to stay at the forefront of pharmaceutical manufacturing excellence.

Why Participate in the PULSE Series?

• Learn from Industry Leaders: Gain insights directly from top experts in pharmaceutical manufacturing and compliance.
• Enhance Practical Skills: Apply actionable strategies to improve operational efficiency and meet regulatory requirements.
• Engage & Collaborate: Participate in interactive discussions to address real-world challenges with fellow professionals.

We encourage you to register for the upcoming session on HVAC Systems & Qualification and take advantage of this unparalleled learning opportunity. Secure your place today by visiting PharmaState Academy’s official website.