Advancing Excellence in Personal Hygiene, Sanitation, and Contamination Control as per Revised Schedule M: Insights from the PULSE Program

We are delighted to share the success of Session 07 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, centered on Personal Hygiene, Sanitation, and Contamination Control. This engaging session attracted over 180 industry professionals, reinforcing PULSE's role as a vital learning platform in the pharmaceutical sector.

The event commenced with a keynote address by Dr. S V Veeramani, Chairman of Pharmexcil and CMD of Fourrts (India) Laboratories Pvt Ltd. Renowned for his significant contributions to the pharmaceutical profession, Dr. S V Veeramani emphasized the crucial role of safety, efficacy, innovation, and affordability in pharmaceutical manufacturing - not just within India, but globally. He highlighted the importance of adhering to Good Manufacturing Practices (GMP) and the potential for increasing exports, while stressing the significance of personal hygiene and sanitation in ensuring product quality and patient safety.

The session featured an expert presentation by Mr. Karan Rajendra Khairnar , Senior Global Technical Manager at Ecolab Life Science, an IRCA GMPPQS Lead Auditor, and a Lean Six Sigma Black Belt (ASQ). Mr. Karan delivered a concise presentation that linked personal hygiene, sanitation, and contamination control directly to the revised Schedule M guidelines. With the revised Schedule M set to become mandatory soon, aligning pharmaceutical manufacturing with global standards is imperative. He underscored the focus on personal hygiene, supervision, training, and regular health check-ups for personnel involved in aseptic processes.

In his presentation, Mr. Karan advocated for science-based training tailored to specific tasks and the validation of minimum personnel requirements in clean areas. He also addressed the importance of proper Personal Protective Equipment (PPE) and clothing in cleanrooms, emphasizing the need for specificity in Standard Operating Procedures (SOPs). Key topics included effective maintenance of clean areas, strategic cleaning frequency, the necessity of diverse disinfectants, and the monitoring of microbial contamination. He warned against relying solely on sporicidal disinfectants due to safety risks and potential material damage. He concluded by stressing the importance of all team members having the necessary knowledge and expertise in contamination control.

To foster engagement, polls were conducted following the presentation, with participants fully involved and actively assessing their understanding.

The session also included a panel discussion moderated by Mr. Chakravarthi AVPS , Chairman (TG & AP) of FOPE, and Honorary Advisor to the Pharmaceutical Export ProMotion Council, Government of India. The panel featured esteemed industry experts:

• Dr. Sanjit Singh Lamba , Managing Partner at Trillyum Consulting and a veteran with over 35 years in the pharmaceutical field.
• Mr. Harish Jain Manawat , President of FOPE and Director at Embiotic Laboratories.

Mr. Karan Rajendra Khairnar , who also presented during the session.

The interactive Q&A session allowed participants to engage with the panelists on critical issues, including the importance of monitoring cleaning operators and the use of disinfectants in facilities. The panelists discussed the necessity of selecting disinfectants with a broad spectrum of microbicidal activity and the significance of conducting a risk assessment when determining cleaning frequency and disinfectant selection.

In closing, Mr. Amit Chawla , Director at McW Healthcare, delivered a heartfelt vote of thanks, expressing gratitude to the speakers, panelists, and participants for their enthusiastic involvement.

As the PULSE series continues to grow in demand, the next session, focusing on Good Documentation Practices, is scheduled for November 3, 2024.

The PULSE initiative remains an essential resource for industry professionals seeking practical compliance knowledge and a deeper understanding of the evolving pharmaceutical landscape.

Join us in the upcoming sessions to stay at the forefront of industry advancements. Register now for the next session on Good Documentation Practices and ensure your spot in this year-long learning journey designed to help you navigate the evolving pharmaceutical landscape.

Secure your participation today and be part of the movement driving excellence in compliance and manufacturing standards.