The Pharmaceutical Engineers Group (PEG) of the Indian Drugs Manufacturers Association (IDMA) today conducted a one-day technical seminar in Mumbai on 'validating pharma water systems-made easy'.
The seminar, participated by more than 150 delegates from different companies, was aimed to offer expert guidance on the need for validation of various water systems associated with the pharmaceutical industry, especially in areas like DM, RO, UV, TOC, distillation, storage and distribution etc.
Introducing the theme, Gidy Asrani, chairman of PEG noted water is a basic necessity for pharmaceutical operations and its quality varies according to season and sources. Though most of the pharma companies use purified water, the purification process itself is lengthy, complicated and expensive. In the emerging scenario of global markets where regulatory mechanisms stress on quality of the products, it is necessary to stress on aspects like water systems, noted Asrani.
Welcoming the gathering, J L Sipahimalani, chairman of the Quality Management and Assurance Committee of IDMA-PEG said it is high time quality aspects like control of microorganisms in the production lines attain prominent importance among the professionals associated with drug manufacturing. Thanks to the excellent response for the seminar, IDMA-would conduct similar seminars in other pharma hubs of the country to create more awareness, said Sipahimalani.
Dr V B Malkar, scientific director of Taro Pharmaceuticals India Pvt Ltd pointed out it is necessary to stress on design and validation of various systems. The concept of validation was introduced in 1960s and is a necessary element as it falls under scrutiny of governing regulatory agencies. Unfortunately most of the companies lack either adequate knowledge or ignore to check the validation aspect. Elements of effective validation include understanding, communication, experience, and involvement of various departments, resources, budget, planning and training.
Yogesh Bhatt of Elomatic Pharmalab Consulting and Engineering Pvt Ltd elaborated on the need for validation. Ajay Popat of Ion Exchange India Ltd spoke on INDION water systems, which follow a standardised validation model, which covers the four phases of planning, design, construction and testing.
Other presentations included Validation of TOC Analyzer by Sheesh Gulati of Measure Test Pvt Ltd., validation of UV disinfectant systems by VA Raju of Alfaa, validating storage and distribution systems by Shoeb Kurawadawala of Christ-Nisho Tech Water Systems Pvt Ltd., Inspection Strategies by Kapil Bharghava of CDSCO etc.