Medicinal Herbs have been in use in India for thousand of years in one form or the other under indigenous system of medicine like Ayurveda, Siddha and Unani and have achieved tremendous developments in process technology, raw material sourcing, standardisation of quality of raw herbs and finished formulation, research and developments of newer formulations.

The manufacture, sale and distribution of Ayurvedic medicines are under the statutory control of The Drugs & Cosmetics Act and Rules framed thereunder. In the manufacture of Drugs and formulations it is absolutely necessary to follow certain specific recommended practices for overall control to ensure that the consumer receives the medicines of guaranteed purity, strength, therapeutic efficacy, potency and safety. These practices are rigidly followed by monitoring various standards of quality prescribed for raw materials and finished products in Official Books and Pharmacopoeias and by monitoring effective controls over all stages of manufacturing operations through statutorily imposed "GOOD MANUFACTURING PRACTICES"

RAW MATERIALS CONTROL
Raw materials used in the manufacture should be authentic, of prescribed quality (with respect to official reference books and pharmacopoeia) and should be free from contamination. Suitable arrangements should be made to evolve and lay down Physico-chemical, morphological and biological tests to identify the drugs, to ascertain its quality standard and to detect adulteration. A preliminary Raw material test protocol must be evolved like follows:
 

MANUFACTURING OPERATION
The manufacturing of Ayurvedic formulation should be as per prescribed process in the Official books recognised in the Drugs & Cosmetics Act and so designed to follow the same in principle so as to maintain standards of quality of finished Ayurvedic formulations, it would be logical to go for proper validated process of manufacturing, validated equipments,stringent environmental controls, systematic documentations of process control parameters.

ENVIRONMENTAL CONTROLS
In general the factory building shall be so situated / constructed to avoid contamination from open sewage, drain, public lavatory or any factory producing disagreeable or obnoxious smell, fumes, excess soot, dust or smoke.
Modern arrangements should be provided like UV - lights, Insectocutors, Air Curtains. Multiple entry or exit points in manufacturing area must be avoided. Interior surface of walls, floors, ceilings should be smooth, free from cracks and should permit easy cleaning and disinfections so as not to retain/accumulate cobwebs, dusts, debris or waste liquids. The rooms shall have covered/concealed drainage systems as well as concealed sanitary and electrical fixtures.

PROCESS CONTROL
To reduce Batch to batch variation in Ayurvedic formulations, systematic documented manufacturing process should be followed as per specified " MASTER BATCH FORMULA" (MBF), which should be well developed in advance to monitor various process control parameters.

STORAGE AND DISPENSING
All raw materials to be processed for manufacturing should be stored in "Raw material stores" with proper ventilation and free from dampness by keeping on pellets / racks to avoid damage or microbial contamination and / or insect-rodent manifestation. There should be adequate space for materials. " UNDER TEST ", "APPROVED", OR " REJECTED" with proper label and arrangements to allow dry, clean and orderly placement and to avoid risk of mix-ups or cross contamination. Properly calibrated and validated weighing balances should be used for dispensing. Storage areas need to be fumigated as per specified time schedule to avoid microbial contamination of raw materials.

EQUIPMENTS
Depending on the nature of products manufactured and bulk volume of the manufacturing/packing operations, suitable equipment, either semiautomatic or automatic machinery, should be provided like crushing, grinding, powdering, boiling, concentration by evaporating, mashing, burning, roasting, frying, centrifuging, filtration, container washing, filling, cap sealing, labeling, packaging etc. These equipments should be validated for proper calibration and brief history to be documented for tracing up maintenance and cleaning schedule . Equipments used for packing must be calibrated for accurate delivery of weight / volume or number as desired and should be validated periodically.

DOCUMENTATION
As per GMP, manufacturing records are required to be provided with an account of the list of raw materials, their quantities issued from stores, various process control parameters like colour, taste, physico-chemical characteristics like pH, specific gravity , weight per milliliter, identification of active ingredients or other tests as may be necessary or indicated either in the in - house test protocols or in the approved books of Ayurvedic Siddha and Unani medicines mentioned in Schedule I of Drugs & Cosmetics Act. Detail records of transfer of manufactured drugs to the stage of finished products store including dates and quantities of finished products along with quality test reports and packing records need to be maintained and these records should be duly signed by production in charge and Quality control in charge.
A procedure for inspection and issue of GMP compliance certificate need to be introduced based on the inspection of the standard methodology and documentation of the Batch Production Records.