Schedule M and Schedule 'M1, M2, M3' ||Pharmaeasynotes ||@Pharmacy ||Jur...

Schedule M
Requirements of manufacturing premises, GMP requirements of factory premises, plants, and equipments.

It includes-
General requirements

Location and surroundings - Free from open sewage, public lavatory, dust, smoke, excessive soot, obnoxious odour, chemical or biological emission.

Buldings and premises - Design suitable for manufacturing operation and maintain hygiene.

Water System - Validated system for water treatment to make it usable and free from microbial growth.

Disposal of wastes - Disposal shall be according to  Environment Pollution Control Board and as per

Warehousing area
Designs allow sufficient and orderly warehousing of various categories of materials and products.

Production area
The area shall be designed to allow the production preferably in uniflow with logical sequence of operation and avoiding the risk of cross-contamination.

Ancillary area
Rest and refreshment rooms shall be separate with changing storing clothes facilities. Washing and toilet purposes shall be easily accessible.

Quality control area
Lab independent of production area with separate and adequate space for each type of testing.

Manufacturing operation
All operations shall be carried out under the supervision of technical staff approved by licensing Authority.

Documentation and record-
It shall specify the title, nature, and purpose and laid out in orderly fashion.

Schedule 'M1'
Requirements of factory premises for manufacture of Homeopathic medicines.

Schedule 'M2'
Requirement of factory premises for manufacture of cosmetics 

Schedule 'M3'
Requirements of factory premises for manufacture of medical devices.

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