MHRA SEMINAR ON DATA INTEGRITY ISSUES IN PHARMA INDUSTRY - UNDERSTANDING AND RESOLUTION

 

Shri.Salim Vejlee, Director, Food and Drugs Administration, Dr.Mansingh Shingte , Suresh Kamath GPMA President , Ms. Rachel Carmichael, UK GMDP Inspector, Sanjay Priolkar, GPMA Vice President.   

Goa Pharmaceuticals Manufacturer's Association (GPMA) and Indian Pharmaceutical Association (IPA) Goa State Branch organized a high value adding seminar on the topic "Data Integrity Issues - Understanding and Resolution by Ms. Rachel Carmichael, GMP Inspector from MHRA – UK at Hotel Mandovi, Panaji, Goa.

This topic is very important to Pharma Industry in the current scenario where regulators found serious observations on data integrity leading to warning letters, Statement of non-compliance, and import alerts thereby impacting consumer’s confidence, losing market share and business for various companies in India.

Over 120 participants from various units in Goa, Maharashtra, Mumbai Gujarat, MP and UP have attended this program. In addition officials from Local FDA and CDSCO Goa Branch office attended this program,

Suresh Kamath, GPMA – President welcomed the gathering and Shri.Salim Veljee; FDA Director addressed the participants on the topic and outcome of the seminar.

Indian Generic formulations /API being cost effective have made huge inroads to many regulated (US & EU) and Rest of the World Markets. All the companies need to follow regulations and standards of various countries in line with to Good Manufacturing Practices to meet the product identity, purity efficacy and safety so that drugs meet its intended use.

On account of recent findings on Data Integrity by various regulatory bodies, we have taken this proactive approach in consultation with MHRA to conduct this seminar for benefit of technical personnel working in various manufacturing plants in Goa. Goa though a small state is one of the major Pharma hub having over 70 manufacturing sites from small to large scale deploying over 50,000 direct and indirect employment opportunities.

Over 80% of total companies in Goa export to various countries to annual turnover of $ 1.2 billion from State of Goa and has huge potential for further growth @ 15-20% annually. It is imperative on these companies meets the standards and regulations so that members of GPMA continue to provide product safety, efficacy and purity issues and avoid business loss on imposition of ban from regulatory bodies.

GPMA & IPA have been conducting these value adding seminars and workshops for the benefit of technical staff of member companies and have been successful in various fields.

The interaction between speaker and participants was overwhelming and exchanged concerns and suggestions to overcome data integrity issues.

Dr.Mansingh Shingte compeered the program and Sanjay Priolkar proposed vote of thanks.

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