Every Ayurvedic, Sidha and Unani manufacturing unit is required to set-up own quality control section or testing should be done through government approved testing laboratory. Tests should be conducted at per Ayurveda, Sidha and Unani pharmacopoeial standard. If tests are not available, tests should be performed under in-house specification or other information available. Work of quality control section is to verify all the raw materials, monitor in-process quality checks and control the quality of finished product being released to finished goods store/warehouse. Preferably for such quality control there will be a separate expert.
Quality Control/Analytical Chemist: Quality control section will have a minimum of :
- Expert in Ayurveda or Sidha or Unani medicine who possesses a degree qualification recognized under Schedule II of Indian Medicine Central Council Act 1970;
- Chemist, who shall possess at least Bachelor Degree in Science or Pharmacy or Pharmacy (Ayurveda), awarded by a recognized University; and
- Botanist (Pharmacognosist), who shall possess at least Bachelor Degree in Science (Medical) or Pharmacy or Pharmacy (Ayurveda) awarded by a recognized University
The quality control section shall have the following facilities:–
- Area for Quality control section should be minimum of 150 sq. feet.
- For identification of raw drugs, reference books and reference samples should be maintained.
- Manufacturing record should be maintained for the various processes.
- To verify the finished products, controlled samples of finished products of each batch will be kept till the expiry date of product for 3 years.
- To supervise and monitor adequacy of conditions under which raw materials, semi- finished products and finished products are stored.
- Keep record in establishing shelf life and storage requirements for the drugs.
- Manufacturers who are manufacturing patent and proprietary Ayurveda, Siddha, and Unani medicines shall provide their own specification and control references in respect of such formulated drugs.
- The record of specific method and procedure of preparation, that is, Bhavana, Mardana and Puta and the record of every process carried out by the manufacturer shall be maintained.
- The standards for identity, purity and strength as given in respective pharmacopoeias of Ayurveda, Siddha and Unani systems of medicines published by Government of India shall be complied with.
- All raw materials will be monitored for fungal, bacterial contamination with a view to minimize such contamination.
List of equipment required for Laboratory in Ayurvedic Manufacturing Units.
(Alternatively, unit can get testing done from the Government approved laboratory)
- Alcohol Determination Apparatus (complete set)
- Volatile Oil Determination Apparatus
- Boiling Point Determination Apparatus
- Melting Point Determination Apparatus
- Tablet Disintegration Apparatus
- Moisture Meter
- Muffle Furnace
- Electronic Balance
- Magnetic Stirrer
- Hot Air Oven
- Glass/Steel Distillation Apparatus
- LPG Gas Cylinders with Burners. Water Bath (Temperature controlled)
- Heating Mantles/ Hot Plates
- TLC Apparatus with all accessories (Manual)
- Paper Chromatography apparatus with accessories
- Sieve size 10 to120 with Sieve
- Centrifuge Machine
- pH Meter
- Limit Test Apparatus
- Microscope Binoculor
- Dissecting Microscope
- Physical Balance
- Aluminium Slide Trays
- Stage Micrometer
- Camera Lucida (Prism and Mirror Type)
- Chemicals, Glassware etc