A three-day course on 'Cleaning Validation', organised by Easy Solutions, a consultancy based product supplier to the Indian life sciences industry was conducted in Mumbai. The course provided a detail insight on FDA's requirements for cleaning validation.
The course was conducted by Destin LeBlanc, an expert in technical consulting services for all aspects of cleaning, cleaning validation, and related technologies for process equipment in pharmaceutical manufacturing and other related industries.
Key personnel from Glenmark, Lupin, Serum Institute, Nicholas Piramal, Johnson & Johnson, Orchid Chemicals, Torrent Pharmaceuticals, Glenmark, Wockhardt, Reliance Life Sciences, Avesthagen, Gengraine, Alembic, Panacea etc participated in the course.
"Cleaning validation has become very critical especially for those units that have the US FDA or MHRA approval. At least 40% of the 483 approvals issued to API units in 2004 by the US FDA were cleaning validation related. This course is designed to be comprehensive, covering aspects from designing the cleaning process, establishing residue limits, selecting appropriate sampling and analytical procedure to revalidation issue," said the sources.
Cleaning technologies, cleaning validation concepts and practice, regulatory aspects of cleaning validation, cleaning methods, analytical and sampling methods, monitoring of cleaning, de-rouging of process equipment, passivation of process equipment, microbial control in cleaning validation for FDA etc were discussed.
LeBlanc, the lecturer for the course, regularly trains FDA investigators on cleaning validation issues. He has spent more than 25 years in the field of pharmaceutical cleaning validation, and has written and lectured internationally on cleaning validation, both as part of technical symposia as well as on-site company training. He holds nine patents and has authored numerous articles including a book on cleaning validation.
Easy Solutions is planning to host many such seminars in the country under the category 'Critical Issues in the Life Sciences industry.' "Our aim through such seminars is to introduce our clients to the current trends in US and Europe," said the sources.