The DIA-ISPE joint conference has stressed on adopting effective internal auditing systems in India to ensure manufacture of high quality APIs and thereby withstand various regulatory systems across the globe.
The two-day Drug Information Association-International Society for Pharmaceutical Engineering (DIA-ISPE) joint conference held during August 1 and 2, 2013 at HICC in Hyderabad has stressed upon building a sustainable and regulatory compliant system for ensuring better quality in the manufacture of Active Pharmaceutical Ingredients (APIs) in India.
Stressing on the need for effective internal auditing for ensuring quality APIs, Nandkumar Chodankar, director of Asolution Pharmaceuticals said, “In the light of stringent regulatory systems evolving across the globe, it is important to have an effective auditing systems to ensure quality and safety of APIs. Use of statistical tools and meaningful reviews should be conducted to establish key performances and evaluate the compliance status regularly.”
As India is already adopting most modern technologies and procedures in the process of manufacturing of high standard APIs it is equally important to build a robust, sustainable and regulatory compliant system which will ensure longer API life cycle, pointed Albinus D’sa, deputy country director US FDA India office. While answering a query on how to maintain consistency in quality of continuous API production Albinus said, “There is no continuous API product manufacturing in India, however for marinating consistency in quality the batches needs to be stopped at regular intervals and should be checked for their quality compliance.”
Apart from discussions on effective auditing system, the first day of the conference also deliberated on various topics. While giving a presentation on ‘Changing regulatory expectations’ Dr Albinus gave insights into current expectations of global regulators for APIs.
Nandakumar Chodankar focused on ICH Q7 interpretations and highlighted on important sections of Q7. Dr Rajiv Desai, president-Quality from Dishman Pharmaceuticals and chemicals gave insights on the topic of ICHQ11 challenges and implementations.
In all about 24 speakers have been roped from across the industry to discuss up on various topics of contemporary issues relating to real-time release testing for the API, ideal contents of management review meetings for monitoring API performance, continuous process verification for legacy APIs, recent regulatory trends risk managements, etc were deliberated during the conference. About 100 delegates from different walks of pharmaceutical industry took part during the conference.