IMDA, ISA organise seminar on equipment validation and documentation

EPP News Bureau - Mumbai

The India Instruments Manufacturers and Dealers Association (IMDA), a representative national organisation encompassing the entire section of the instrumentation industry and trade, along with the Instrumentation, Systems and Automation Society (ISA) had organised a seminar on equipment qualification, validation and documentation recently here.

Rajan R Pol, assistant director, Drug Control Laboratory, FDA, Maharashtra, in his welcome speech said quality control, economising costs, optimising productivity with rapid automation and documentation are the keywords that would aid Indian companies not only to exploit and explore the tremendous potential the healthcare segment has to offer but also sustain viable operations in the years to come.

Operational qualification is documented verification ensures that the equipment or system as installed or modified, perform as intended throughout the anticipated operating ranges, said

Dr Vishwanath Malkar, Taro Pharmaceuticals Ltd, Mumbai in his keynote address, dwelled on design qualification, installation qualification and operational qualification. Speaking on equipment qualification, validation and documentation, he said that design qualification is a documented verification that the proposed design of the facilities, equipment or system is suitable for intended purpose.

Explaining further he said installation qualification is documented verification that the equipment or systems as installed or modified comply with the approved design according to manufacturer’s recommendation and user’s requirements.

V U Kulkarni, CEO, Spectra Labs made a presentation on advantages of mini cooling systems working on Peltier effect.

Anil D Nimkar, general manager, Molecular Spectroscopy, Perkin Elmer, in his presentation on near infrared (NIR) deployment in pharmaceutical industry dealt with its advantages over mid infrared spectroscopy.

Dr Amit Bandopadhyay, general manager, Analytical Instruments; Baboo Nagarsheth, chairman and managing director, Altop Industries Ltd; B K Godbole, district vice-president, ISA; Chander P Golani, PCI Services and V U Kulkarni, Spectralab presided over the function.