SCHEDULE M

[ SCHEDULE M] [See Rules 71, 74, 76 and 78] GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS. Note: - To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs and no other manufacturing activity shall be undertaken therein. PART 1 GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS. 1. GENERAL REQUIREMENTS Location and The factory building(s) for manufacture of drugs shall be so situated and shall have such measures as to avoid risk of contamination from external environmental including open sewage, drain, public lavatory or any factory which product disagreeable or obnoxious odour, fumes, excessive soot, dust, smoke, chemical or biological emissions.

2.12. Rodent treatments (Pest control) should be done regularly and at least once in a year and record maintained. 3. Production area. - 3.1. The production area shall be designed to allow the production preferably in uni-flow and with logical sequence of operations. 3.2. In order to avoid the risk of corss-contamination, separate dedicated and

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