FOPE and PharmaState Academy’s PULSE initiative delivers insights on water systems and qualification in pharma manufacturing

On September 22, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 5 of the PULSE (Pharma Upgradation and Learning Series for Excellence) initiative, focusing on Water Systems and Qualification. The session attracted over 180 attendees, continuing the PULSE series’ role as a key learning platform for industry professionals.

Session Highlights:

The event began with a keynote address by Manish Kapoor, State Drugs Controller of Himachal Pradesh, who emphasised the critical role that water systems play in maintaining pharmaceutical product quality. He applauded the PULSE initiative for focusing on this crucial aspect of compliance and stressed the importance of compliance with Revised Schedule M.

Expert Educator:
The session was led by Shoeb Kurawadwala, Founder and MD of CN Water and an expert in Water for Pharmaceutical Purposes.

Presentation Highlights:

1. Water systems must be designed, installed, and maintained to ensure consistent production of high-quality water for pharmaceutical use, with regular monitoring for chemical, microbiological, and endotoxin contamination.
2.  Qualification and validation are essential ongoing processes that should not be viewed as one-off exercises and must be supported by a periodic review to ensure the system’s reliability​
3. Risk reduction in water systems is achieved through proper design, installation, operation, and maintenance, with a focus on regular sanitisation and contamination control to prevent microbial proliferation.
4. The application of different water grades—such as Purified Water (PW) and Water for Injection (WFI)—must be carefully managed to match the specific requirements of various manufacturing processes and dosage forms

He provided practical guidance on maintaining water quality across Purified Water (PW) and Water for Injection (WFI) systems, aligning these processes with international standards.
Next up were quizzes for the participants, which saw full engagement, with 80 per cent of the responses answered correctly.

Panel Discussion:
The session’s panel discussion, moderated by Harish Jain, President, FOPE, featured the following industry experts:

• Shoeb Kurawadwala, Founder & MD, CN Water, and
• Dr Sanjit Singh Lamba, Managing Partner, Trillyum Consulting and pharma veteran with over 35 years of experience,
• Rajesh Madan, CEO, Medicamen Biotech,
• Manojkumar Singh, Founder, Maanvi Ecotech, an expert in ultrapure water systems with 24 years of experience.

The panelists shared invaluable insights on water system design, qualification strategies, and risk-based approaches to water management. 

Engaging Q&A Session:
The panel discussion was followed by an interactive Q&A session, where participants explored key challenges related to water systems. Topics ranged from reducing microbial risks to ensuring effective requalification after facility upgrades. Shoeb Kurawadwala offered insights into the risk-based approach to requalification, while Rajesh Madan highlighted the cost-efficiency of investing in high-quality water systems. Manojkumar Singh added practical perspectives on maintaining data integrity and change control within water systems, emphasising the need for ongoing monitoring to ensure compliance. Dr Sanjit Singh Lamba emphasised the importance of aligning water systems with global regulatory standards, ensuring continuous process verification to maintain system integrity and avoid compliance issues.
The session concluded with a vote of thanks by Arjun Kapoor, expressing gratitude to the speakers, panelists, and participants for their active involvement. The next session in the PULSE series, focusing on HVAC Systems & Qualification, is scheduled for October 6, 2024. As demand for practical compliance knowledge grows, the PULSE initiative remains an essential resource for industry professionals.

The PULSE series continues to receive support from key industry associations, including CIPI, Laghu Udyog Bharati, Indian Pharma Machinery Manufacturers Association, Karnataka Drugs and Pharmaceuticals Manufacturers Association, and many more. Express Pharma serves as the Media Partner, with Trillyum Consulting as the Knowledge Partner. Stay tuned for updates on the PULSE initiative and upcoming sessions.