AIDCOC, Millipore organise workshop on web and aseptic processing

EPP News Bureau - Bangalore

The All India Drugs Control Officers’ Confederation (AIDCOC) recently organised a two-day workshop on ‘The Web and Aseptic Processing - II’ at Bangalore.

Drug control experts and the pharmaceutical industry discussed emerging domestic and international regulatory trends at the workshop which was jointly organised with Millipore India.

The workshop focussed on the Pharmacopoeial Perspective on Aseptic Processing. Emerging areas like rapid microbiological monitoring evinced great interest as did the pivotal role of risk assessment and risk management in a microbiological environment and microbiological guidelines in classical pharma and fermentation, vaccinology and biotechnology set up.

A Ramakrishnan, IAS and Commissioner, Food and Drugs Control Administration, (MS) was the chief guest while Dr M Venkateshwarlu, Dy Drug Controller (India) was the Guest of Honour on the occasion.

The workshop got off to a lively start at the plenary session with the president of AIDCOC S W Deshpande and president of Millipore India, Sudhir Kant welcoming over a hundred professionals from the Indian FDA, pharmaceutical/ biotech companies and bioscience companies from India and abroad.

Rajiv Gulati, chairman and managing director, Eli Lilly & Company in his keynote address outlined the emerging trends and challenges facing the industry.

According to a press release, ‘The Web of Aseptic Processing’ programme, since the first such programme in year 2002 has gained the respect of Indian Drug Control Officers and the industry as a forum that promotes professional excellence, training and interaction between pharmacists and regulatory officers on Indian and international trends and issues in the vital area of healthcare delivery.

This was the second such programme from AIDCOC and Millipore with delegates from the functional areas of pharmaceutical R&D, QA/QC, manufacturing, project management, validation and process development among others, in attendance, the release added. The panel of speakers included eminent and distinguished Indian experts from quality assurance, R&D, and regulatory affairs.

Also in attendance as presenters and panel members was a senior team of technologists from the Technology Group, European HQ, Millipore. The Technology Group with its expertise in the technologies of sterile filtration, bio-burden monitoring and integrity testing in sterile APIs, biologicals, oncology and ophthalmic applications shared their international perspective and experiences.

The two-day workshop had rich interactive discussions on recent developments like the new guidelines on sterile drugs produced by aseptic processing and strategies for establishing a compliant environmental monitoring program and implementing the new FDA initiatives on aseptic processing.