Good Manufacturing Practice for Medicinal Plants: Herbal medicines are prepared from materials of herbal origin, which are often obtained from different geographical and/or commercial sources. As a result, it may not always be possible to determine the conditions to which, they may have been subjected as well as they may vary in composition and properties. Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use. Herbal drugs are considered to be adulterated if GMPs are not met. GMP standards are the only guidelines, alternative processes, and control mechanisms that can be used as an essential tool to assure quality.
Objectives of GMP:
- Raw materials used in the manufacture of drugs are authentic, of prescribed quality, and are free from contamination.
- The manufacturing process 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.
General Requirements To Establish Good Manufacturing Practice for Medicinal Plants:
(a) Infrastructural requirements:
The manufacturing plant should have adequate space for manufacturing process areas, quality control section and finished goods store, receiving and storing raw material office, office for rejected goods/drugs store, etc. Location and surroundings of the pharmacy should be situated where there is:
- No open sewage.
- No drainage coming from public areas and the public lavatory.
- No factory fumes.
- No excessive soot, smoke, and dust.
- Buildings should be in hygienic condition.
- No cobwebs/insects/rodents.
- Sufficient light, ventilation, and working space.
- No dampness or moisture should be there on the floor and walls,
- Wall and floors should be even.
- Premises used for manufacturing, processing, packaging, and labeling should be according to the provisions of the Factory Act.
- Proper placement of equipments to avoid the risk of mixing and cross-contamination.
- Designed, constructed, and maintained well to prevent the entry of insects/rodents. The interior surface should be smooth, easy for cleaning and disinfection.
- The parking bay should be smooth and even so as not to permit retention or accumulation of dust or waste products.
(c) Proper drainage system:
- Sanitary fittings and electrical fixtures should be used for safety.
- The furnace section should be covered with a tin roof.
- Proper ventilation/chimney in the factory.
- Prevention of flies and dust in factory premises.
- Proper fire safety measures/exits should be installed.
(d) Water Supply:
The water used in manufacturing should be pure and of potable quality. An adequate supply of water is required for washing the premises and containers.
(e) Disposal of Waste:
In the manufacturing section and laboratories, the wastewater and residues are disposed of after suitable treatment as per the guidelines of pollution control to be followed.
(f) Containers Cleaning:
Adequate arrangements for washing, cleaning, and drying of containers should be there.
There should be sufficient space for stores of different types of material such as; raw materials, packing materials, and finished products. The store should have proper ventilation and should be free from dampness.
1. Raw materials stores: Raw materials stores should have appropriate containers which would protect the quality of raw materials and prevent contamination, rodents, and insects. Suitable cabins should be maintained for raw material of metallic, mineral, animal origin, fresh herbs, dry herbs, plant parts, excipients, volatile oils/perfumes, flavors, plant extracts, exudates/resins, etc. Each container used for raw material storage should be identified with the label which indicates the name of the raw material, source of supply and should also clearly state the status of raw material such as; under test or Approved or Rejected. Records of the receipt, testing, and approval or rejection should be maintained.
2. Packing materials stores: All packing materials such as; bottles, jars, capsules, etc. should be stored properly. All the container and closure lids should be properly cleaned and dried before packing the products.
3. Finished goods stores: The finished goods transferred from the production area after proper packaging should be stored on proper shelves within an area marked “Quarantine”. After the quality control laboratory test and the experts have checked the correctness of finished goods then they should be moved to the approved finished goods stock area. Only approved finished goods should be dispatched as per marketing requirements.
(h) Working Space:
The manufacturing area should provide adequate space for organized placement of equipment and material used in any of the operations. There should be proper facilities for easy and safe working. Facilities to minimize or eliminate mixing up of the drugs should be provided to prevent cross-contamination of one drug by another drug that is manufactured, stored, and handled on the same premises.
(i) Health, clothing, sanitation, and hygiene:
Workers should be free from contagious diseases. They should use proper uniforms suitable to work. Hands should be covered with cloth or synthetic covering. Personal cleanliness, clean towel, soap, scrubbing brushes, separate lavatories for men and women should be maintained.
A facility for changing clothes and cupboards to keep their clothes and belongings should be provided.
Herbal materials may contain microbiological contaminants. During harvesting and processing, herbal products that are prone to microbial contamination are produced. To avoid alterations and reduce contamination, a high level of sanitation and hygiene is necessary during the manufacturing process.
Waste from the manufacturing unit should be disposed of regularly to maintain a high standard of hygiene in the manufacturing area. Waste bins should be available, emptied, and cleaned at least daily.
(j) Medical Services:
Annual medical check-ups of all employees should be done to ensure freedom from infectious diseases. The first-Aid facility should be available and the health record of all the employees should be maintained.
(k) Machinery and Equipment:
Equipment should be according to the size of the operation and the nature of the product manufactured. Semi-automatic or automatic machines should be available in the manufacturing unit such as; crushing, grinding, powdering, boiling, mashing, burning. roasting, filtering, drying, filling, labeling and packing, etc. To ensure comfort in the movement of workers adequate space should be ensured between two machines or rows of machines. These equipments have to be properly installed and maintained with proper cleaning. Proper Standard Operational Procedures (SOPs) for cleaning, maintaining, and performing every machine should be maintained.
(l) Batch Manufacturing Records:
It includes records of raw materials used, the quantity obtained from the store tests conducted during the various stages of manufacture like; taste, color, physical characteristics, and chemical tests. All manufacturing records should be duly signed by production and quality control personnel respectively. It is essential to maintain the record of the date, manpower, machine, equipment used along with the in-process record of various Shodhana (purification procedures of poisonous drugs), trituration in terms of internal use.
(m) Distribution records:
Records of sale and distribution of each batch of Ayurveda, Siddha, and Unani drugs should be maintained to facilitate quick and complete recall of the batch when needed.
(n) Record of market complaints:
Manufacturers should maintain a register to record the complaints as well as corrective action initiated to prevent repetition regarding the products. Once in six months, the complaint records have to be sent to the licensing authority. A register should be available for inspection during any inspection of the premises. Reports of any adverse reaction resulting from the use of drugs should be maintained in a separate register.
(o) Quality Control:
Every licensee is required to provide a facility for a quality control section in his premises or Government approved testing laboratory. The test should be as per the Ayurveda, Siddha, and Unani Pharmacopoeia standards. There should be a 150 sq. feet area for the quality control section.
The manufacturing record should be maintained for the various processes. The finished products, controlled samples of finished products of each batch should be kept for 3 years. The standards for identity, purity, and strength as given in respective pharmacopeias of Ayurveda, Siddha, and Unani systems of medicines published by the Government of India should be maintained. All the raw materials should be monitored for virus, fungal and bacterial contamination to minimize such contamination. The quality control section should have one person with a Degree qualification in Ayurveda/Siddha/Unani (A.S.U.) as per Schedule II of Indian Medicine Central Council Act, 1970 (84 of 1970) of a recognized university or board. A person with a Bachelor of Pharmacy, Pharmacognosy, and Chemistry can accompany with the quality control section.
(p) Requirement of Sterile Product:
Manufacturing area for the production of sterile Ayurvedic products, the separate enclosed area should be provided. This area should be aseptic, dust-free, moisture less and should have a bacteria-free air supply.
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