Strengthening Quality Systems: A Deep Dive into Good Practices in Quality Control

On December 15, 2024, the 11th session of the PULSE Series, a collaborative initiative by the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy, convened pharma professionals to explore the critical topic of Good Practices in Quality Control. This session provided in-depth insights into implementing quality control measures in line with the Revised Schedule M, addressing real-world challenges and fostering operational excellence in pharmaceutical manufacturing.

Quality control is pivotal to ensuring product safety, consistency, and compliance in pharmaceutical operations. The Revised Schedule M outlines clear guidelines for establishing robust quality control systems that align with global standards. This session brought together industry experts to share practical strategies and best practices to enhance quality systems, validation processes, and data integrity.

Session Highlights

Keynote Address:

Dr. Y K Gupta, President, AIIMS Jammu, and Principal Adviser, GARDP (Global Antibiotic Research and Development Partnership), delivered the keynote address, emphasizing the critical role of quality control in safeguarding patient safety and maintaining industry reputation. He highlighted the need for:

• Stringent quality measures to align with global regulatory standards.
• Continuous improvement and investment in quality systems to enhance operational efficiency.

Dr. Y K Gupta underscored that as a global hub for generic drugs, India's pharmaceutical industry must prioritize compliance with the Revised Schedule M to meet international benchmarks.

Presentation by Dr. Deo Narain Dikshit

Dr. Deo Narain Dikshit, (Director at AQEX Phamasolutions Pvt. Ltd. | Former Vice President and Regional Quality Head Asia in Sun Pharma), delivered an engaging presentation on Good Practices in Quality Control. Key points included:

• Independence of Quality Control: Each manufacturer shall have a QC function. The QC function shall be independent of other departments and under the authority of a person with appropriate qualifications and experience.
• Validation and Calibration: Regular validation of analytical methods, equipment calibration, and ensuring accuracy in test results.
• Good Laboratory Practices (GLP): Standardizing sampling methods, maintaining controlled environments, and ensuring compliance with predefined protocols.
• Retention Samples: Proper management of retention samples for raw materials and finished products to facilitate investigations.

Dr. Deo Narain Dikshit stressed that robust quality control systems are essential for identifying deviations, ensuring compliance, and maintaining product quality.

Panel Discussion and Q&A:

The session featured an interactive panel discussion moderated by Mr. Harish Jain Manawat, (President FOPE, Director Embiotic Laboratories), with insights from distinguished panelists:

• Dr. Deo Narain Dikshit, (Director at AQEX Phamasolutions Pvt. Ltd. Former Vice President and Regional Quality Head Asia in Sun Pharma)
• Dr. Jitender Khurana, (International GMP Consultant: Quality System, Auditing, FDA Remediation and Training)
• Mr. Subhrangshu Chaudhury, (Vice President & Head of Quality at Centaur Pharmaceuticals Pvt. Ltd.)

Key Discussion Points:

• Risk-Based Testing: Implementing risk-based approaches to prioritize critical quality attributes and ensure compliance.
• Method Validation: The importance of validating analytical methods, especially when outsourcing testing to third-party laboratories.
• Vendor Management: Evaluating suppliers and ensuring compliance in subcontracted facilities.
• Automation and Digitalization: Reducing human error through automated systems and maintaining data integrity.
• Sampling Practices: Ensuring 100% sampling of excipients and raw materials to meet regulatory standards.

During the Q&A segment, panelists addressed audience queries on retesting raw materials, stability samples, and managing deviations, offering actionable solutions to common challenges faced by MSMEs.

Advancing Pharma through Knowledge Sharing The PULSE Series remains committed to empowering pharma professionals by providing actionable knowledge and fostering a culture of shared growth and improvement.

📢 Next in the PULSE Series: ✨ Topic: Complaints and Product Recall 📅 Date: December 29, 2024 (Sunday)

Stay tuned for more engaging sessions aimed at strengthening industry practices and addressing key challenges. Together, let’s elevate pharmaceutical standards to new heights!

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