hi
i wanted to know about the area specifications of changing rooms in homoeopathic pharmaceutical factory?
is there any specific requirement for room size?
anyone has any idea?
Please note the following requirements as per the Indian Drug &cosmetics Rules, 1945 under ScheduleM-1 titled GMP AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR HOMOEOPATHIC MEDICINES,
Section 2. PLANT AND EQUIPMENT:
2.1 General: - The design of the plant shall be suitable for the nature and quantum of the activities involved. Equipment shall be installed in such a manner as to facilitate the easy flow of materials and to check the crisscross movement of the personnel. The entry to all manufacturing sections shall be regulated and persons not associated with the activities in the sections shall not have access to them. There shall be arrangements for the personal cleanliness of workers and toilets. These shall be separate for men and women workers. There shall be suitable arrangements, separate for men and women, to change from their outside dress and footwear into the factory dress and footwear. Uniforms of suitable colours and fabric which facilitate proper washing and which do not shed fibres, or other contaminants shall be provided. Suitable headcovers and gloves shall be provided to the workers. The manufacturing premises shall not be used for dining. There shall be a separate area for the personnel to take food or rest. Toilets shall be located in or adjacent to any of the areas concerned with any manufacturing activity.
(Please note that there is no specific requirement of the area specification for the change room design given under the referred schedule)
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