Part 1 Describes the Good Manufacturing Practice of Ayurvedic, Sidha and Unani Medicines.
GOOD MANUFACTURING PRACTICES FOR AYURVEDIC, SIDDHA AND UNANI MEDICINES
The Good Manufacturing Practices (GMP) are prescribed as follows in Part I and Part II to ensure that:
- Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination.
- The manufacturing process is as has been prescribed to maintain the standards.
- Adequate quality control measures are adopted.
- The manufactured drug which is released for sale is of acceptable quality.
- To achieve the objectives listed above, each licensee shall evolve methodology and procedures for following the prescribed process of manufacture of drugs which should be documented as a manual and kept for reference and inspection. However, under IMCC Act 1970 registered Vaidyas, Siddhas and Hakeems who prepare medicines on their own to dispense to their patients and not selling such drugs in the market are exempted from the purview of G.M.P.
Good Manufacturing Practice for Ayurvedic, Sidha and Unani Products:
A Manufacturing Premises should have adequate space for all daily activity like:
- Receiving and Storage of Herbs, Packaging material & other raw material
- Production and Manufacturing Activity Area
- Quality Control Section
- Finished Goods Store
- Office and Administration
- Rejected Products/Drugs Store
Minimum area required for setting up Ayurveda, Sidha and Unani Medicine manufacturing unit is 1200 square feet covered with separate cabins and partitions for each activity. If unani medicines/ayurvedic medicine are manufactured along with ayurvedic medicine/unani medicine additional 400 square feet area is required.
- Location and Surroundings: The factory building for Ayurveda, Sidha and Unani Medicine manufacturing shall be situated and constructed to avoid contamination from open sewerage, drain, disagreeable or obnoxious odour, dust and smoke etc.
- Buildings: A building for manufacturing unit for Ayurvedic, Sidha and Unani Medicines shall permit work under hygienic conditions. It should be free from any insects/rodents. Light and ventilation facility should be adequate. Walls and floor should be free from cracks and damp. Premises should also conformity with provisions of factory act. It shall be located so as to be:
- Building should compatible of other manufacturing operations carried out in same premises.
- Space should be adequate for Placement of equipment and materials to avoid mix-up/contamination risk of different drugs and components.
- 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.
- Building should have a proper drainage system. Sanitary fitting and electric fixtures shall be proper and safe.
- Burner/Bhatti section could be covered with tin roof and proper ventilation but care should be done to prevent flies and dust.
- Proper fire safety measures and proper exists should be there.
- Drying space for raw material, in process medicines should be separate and measures should be done to prevent it from flies/insects/dust etc.
- Water Supply: Water needed for manufacturing should be pure and of potable quality. Adequate provision of water for wasting the premises shall be made.
- Disposable of Waste: Proper waste management care should be done.
- Container’s Cleaning: Washing, cleaning and drying section of containers such as bottles, vials and jars should have adequate arrangement and should be separated from manufacturing operations.
- Stores: Store should have adequate space for independently and separately store raw material, packaging material and finished products. Read in detail Storage of Ayurvedic, Sidha and Unani Products under Goods Manufacturing Practice.
- Working Space: Manufacturing area should be adequate for orderly placement of equipment, machinery and material used during manufacturing operations and quality control to facilitate easy and safe working and to minimize or eliminate any risk of mix-up between different drugs, raw materials and to prevent the cross contamination during manufacturing, storage and handling operations.
- Health Clothing, Sanitation and Hygiene of Workers: All workers should be healthy and should be free from any contagious diseases. Proper uniform should be provided to workers according to nature of work and the climates. It should be clean. A uniform may include cloth or synthetic covering for hands, feet and head wherever required. Adequate facilities for personnel use should be provided like clean towel, soap etc. Lavatories for men and women should be separate and should away from processing and manufacturing area. Changing room facility should also be provided for changing their clothes and to keep their personal belongings.
- Medical Services: Adequate facility for first aids should be provided by manufacturer. Medical examination of workers at the time of employment and periodical check-up should be conducted at least once in a year and proper record should be maintained.
- Machinery and Equipments: To carryout manufacturing process, adequate machinery and equipment require. These machinery could be manually operated or semi-automatic or fully automatic based upon your need and investment. Read in detail about machinery and equipment in Part II of Schedule T.
- Batch Manufacturing Record: Each batch record should be maintained irrespective of product manufactured (classical preparations or patent or proprietary medicines). Manufacturing records are required to provide an account of the list of raw materials and their quantities obtained from the store, tests conducted during the various stages of manufacture like taste, colour, physical characteristics and chemical tests as may be necessary or indicated in the approved books of Ayurveda, Siddha and Unani mentioned in the First Schedule of the Drugs and Cosmetics Act. These tests may include any in-house or pharmacopoeial test adopted by the manufacturer in the raw material or in the process material and in the finished product. Manufacturing Batch record should be signed by production chemist and analytical chemist. Stock should be transferred to finished goods store along with record of testing with date and quantity of drug. Only after the manufactured drugs have been verified and accepted quality shall be allowed to be cleared for sale. It should be essential to maintain the record of date, manpower, machine and equipment used and to keep in process record of various shodhana, bhavana, burning and fire and specific grindings in terms of internal use.
- Distribution Record: Distribution record (Dispatch register) should be maintained to facilitate process of prompt and complete recall of the batch. Distribution record should be maintained till expiry of batch. For drugs who don’t have expiry date like Bhasma, Rasa, Asava-arishtha etc, record should maintain upto five years of the exhausting of stock.
- Record of Market Complaints: A complain register should maintain to record all reports of market complaints received regarding the products sold in the market. . The manufacturer shall enter all data received on such market complaints, investigations carried out by the manufacturers regarding the complaint as well as any corrective action initiated to prevent recurrence of such market complaints shall also be recorded. Once in a period of six months the manufacturer shall submit the record of such complaints to the licensing authority. The Register shall also be available for inspection during any inspection of the premises.
Reports of any adverse reaction resulting from the use of Ayurvedic, Siddha and Unani drugs shall also be maintained in a separate register by each manufacturer. The manufacturer shall investigate any of the adverse reaction to find if the same is due to any defect in the product, and whether such reactions are already reported in the literature or it is a new observation.
- Quality Control: A manufacturer can set-up own quality control section or testing could be done through government approved testing laboratory read in detail about Ayurvedic, Sidha and Unani manufacturing unit quality control Section:
Part 2 describes a list of recommend machinery, equipment and minimum manufacturing premises required for the manufacture of various categories of Ayurvedic, Siddha system of medicines. read in detail about machinery, equipment and minimum manufacturing premises here