Indian Government has laid down Good Manufacturing Practices guidelines to be followed by manufacturing plants
Good Manufacturing Practices of Ayurveda
The manufacturing plant should have adequate space for:- Receiving and storing raw material.
- Manufacturing process Areas
- Quality control section.
- Finished goods store
- Rejected goods/drugs store
- Location and surroundings: The factory buildings for manufacture of Ayurveda, Siddha and Unani medicines shall be so situated and shall have such construction as to avoid contamination from open sewrage, drain, public lavatory or any factory which produces disagreeable or obnoxious odour or fumes or excessive soot, dust or smoke.
- Buildings: The building used for factory shall be such as to permit production of drugs under hygenic conditions and should be free from cobwebs and insects/rodents. It should have adequate provision of light and ventilation. The floor and the walls should not be damp or moist. The premises used for manufacturing, processing, packaging and labeling will be in conformity with the provisions of the Factory Act.
It shall be located so as to be:
- Compatible with other manufacturing operations that may be carried out in the same or adjacent premises.
- Adequately provided with working space to allow orderly and logical placement of equipment and materials to avoid the risk of mix up between different drugs or components thereof and control the possibility of cross contamination by other drugs or substances and avoid the risk of omission of any manufacturing or control step:
- Designed, constructed and maintained to prevent entry of insects and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from cracks and permit easy cleaning and disinfection. The walls of the room in which the manufacturing operations are carried out shall be impervious to and be capable of being kept clean. The flooring shall be smooth and even and shall be such as not to permit retention or accumulation of dust or waste products.
- Provided with proper drainage system in the processing area. The sanitary fitting and electrical fixtures in the manufacturing area shall be proper and safe.
- Furnace/Bhatti section could be covered with tin roof & proper ventilation, but sufficient care should be taken to prevent flies and dust.
- There should be fire safety measures and proper exits should be there.