The Centre for cGMP (current Good Manufacturing Practices) at Manipal College of Pharmaceutical Sciences (MCOPS), Manipal Academy of Higher Education (MAHE), has announced the first-ever “National Current Good Manufacturing Practices Day” or “National cGMP Day”, which is scheduled to be held on October 10, 2023. This occasion coincides with the Diamond Jubilee of MCOPS and the 125th Birth Anniversary of its visionary founder, Dr. TMA Pai, Padmashree Awardee.
The purpose of “National cGMP Day” is to create awareness about the critical role of cGMP in the pharmaceutical industry, ensuring the quality and safety of medicinal products. Dr. Girish Pai K, Coordinator of the Centre for cGMP, emphasized that this day aims to foster a culture of quality in both academia and the industry.
The choice of October 10th as “National cGMP Day” holds special significance. On this day in 1962, major amendments were introduced by international regulatory agencies following the historic Thalidomide disaster. These amendments revolutionized drug development, requiring manufacturers to scientifically demonstrate the safety and efficacy of medications.
The day will commence with the inauguration which will be attended by national president of the IDMA, Dr. Viranchi Shah from Gujarat, the Drug Controller General of India Dr. Rajivsingh Raghuvanshi from Delhi, Chairman of the Pharmaceuticals Export Promotion Council Dr. S V Veeramani from Hyderabad, President of KDPMA Mr Harish K Jain and leaders of IDMA of all state boards will attend the first meeting to be held in Manipal. The ADC of Udupi, Dr S Vidya and other regulatory officers of Mangalore Udupi districts will also participate at the celebration function. The highlights of the day include 3 symposiums, followed by a mini workshop, and panel discussion featuring nine industry experts. Topics to be covered includes recent international regulatory updates, GMP Compliance, products for global markets, quality and regulatory challenges, cGMPs in manufacturing and distribution, and the future of cGMP compliance.
Each year, “National cGMP Day” will focus on important quality issues, including Not of Standard Quality (NSQ) products, Data Integrity issues, Compliance, Stability, Labelling errors, Recalls, Complaints Handling, Manufacturing Assurance, Analytical Assurance, FDA warning letters, Import alerts, Out of Specification, Out of Trend, and more.
Nationwide awareness programs are planned by state boards of the IDMA by conducting seminars and discussions on the day in respective areas by inviting regulatory officials and the public. All over the country 22 seminars are in the planning.