The SSI Sub-Committee of the Indian Drug Manufacturers’ Association (IDMA) is organizing a one-day workshop on “Schedule M – Upgradation for progressive SSI units” on Wednesday, May 5, 2004 in Mumbai.
The Ministry of Health & Family Welfare had published a Gazette Notification, substituting Schedule M to the Drugs and Rules, 1945 laying revised requirements of GMPs relating to premises, plant, equipments needed to be evolved by the manufacturers of drugs. The amended Schedule M was to apply to the existing manufacturers with effect from 01.01.2004.
The Ministry of Health has considered, after several representations from the Industry, to extend the cut-off date up to 31.12.2004 and the provisions of the revised Schedule M will be made applicable with effect from 01.01.2005.
The workshop has been planned, on receipt of a large number of answered questionnaires from our members, in order to educate our members in various areas for complying with the Schedule M requirements.
The workshop will cover the following important topics deliberated upon by various experts in their respective fields like documentation and validation, water systems, air handling, plant layout etc.