Rasashala Nirmana (Construction of Rasashastra pharmacy), GMP

Rasashala is the place for the manufacturing of Rasashastra medicines. Since it has significance in terms of business and auspiciousness, a suitable place with specific features has been advised.

Features and place

devoid of Serpent curse, should be selected. The place should be –
Good, lonely, where most of the medicines are easily available in the vicinity. Thare should be accessibility for good water, electricity and light. Laborers should be easily available. Vastu of the location should be correct. The place selected for the construction of pharmacy should have proper ventilation.
Pharmacy should have different sections for different types of processes, having good facilities and infrastructure for installing instruments, storing raw drugs etc. It should also have good water and drugs storage facilities.
Read: Introduction To Rasashastra: Using Metals And Minerals To Heal

Direction-wise construction of Rasashala

Purva (East) – Rasa Bhairava. The Pooja of Rasa Bhairava is very important for the success in Rasashastra (Rasasiddhi).
Agneya (South-east) – Agnikarma: In the south-east direction of the pharmacy, all the processes involving fire such as Bhatti Nirman, Koshti, Puta etc should be done.
Dakshina (South) – Pashanakarma: All the processes involving rocks such as Khalwa, pulverizers, Bhavana, Mardana etc should be done in the south direction.
Nairutya (South-west) – Shastrakarma: All the processes involving sharp instruments such as cutting the wood, etc should be done in the south direction.
Paschima (west) – Kshalana: All processes involving washing should be done in the west direction.
Vayuvya (North-west) – Shoshana: All processes involving wind-like drying should be done in a north-west direction.
Uttara (North) – Vedha:  All the processes like piercing, shearing etc are done in the north direction.
Eeshanya (North-east) – Siddha dravya samrakshana: All the finished products should be stored in the North-east direction.
Read more: Concept Of Shodhana In Rasashastra – Purification Of Metals, Minerals

According to modern concepts, the building should be as per the norms of Schedule ‘T’ of the Drugs and Cosmetic Rules – 1945. Which is as follows:

Good Manufacturing Practices

Factory Premises:
The manufacturing plant should have adequate space for: –
(i) receiving and storing raw material;
(ii) manufacturing process areas;
(iii)Quality control section;
(iv)finished goods store;
(v) office;
(vi)rejected goods/drugs store.

General Requirements

1.1(A) Location and surroundings. – The factory building for manufacture of Ayurveda
medicines shall be so situated and shall have such construction as to avoid contamination from open sewage, drain, public lavatory for any factory which produces disagreeable or obnoxious odour or fumes or excessive soot, dust and smoke.
Read: Definition of Ayurvedic Herbal Pharmaceutics – Bhaishajya Kalpana

1.1(B) Buildings. – The buildings used for factory shall be such as to permit production of
drugs under hygienic 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:
(I) Compatible with other manufacturing operations that may be carried out in the same or adjacent premises.

(II) 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.

(III) Designed, constructed and maintained to prevent entry of insects and rodents.
Interior surfaces (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.

(IV) Provided a proper drainage system in the processing area. The sanitary fittings and electrical fixtures in the manufacturing area shall be proper and safe.

(V) Furnace/Bhatti section could be covered with tin roof and proper ventilation, but sufficient care should be taken to prevent flies and dust.

(VI) There should be fire safety measures and proper exits should be there.

(VII) Drying Space: – There should be separate space for drying of raw materials, in process medicine or medicines require drying before packing. This space will be protected from flies/ insects/ dust etc., by proper flooring, wire mesh window, glass panels or other material.

1.1(C) Water Supply. – The water used in manufacture shall be pure and of potable quality. Adequate provision of water for washing the premises shall be made.

1.1(D) Disposal of Waste. – From the manufacturing section and laboratories the waste

water and the residues which might be prejudicial to the workers or public health shall be disposed off.

1.1(E) Container’s Cleaning. – In factories where operations involving the use of containers such as glass bottles, vials and jars are conducted, there shall be adequate arrangements separated from the manufacturing operations for washing, cleaning and drying of such containers.

1.1(F) Stores. – Storage should have proper ventilation and shall be free from dampness.

It should provide independent adequate space for storage of different types of material, such as raw material, packaging material and finished products.

1.1. (F)(A) Raw Materials. – All raw materials procured for manufacturing will be stored in the raw materials store. The manufacture based on the experience and the characteristics of the particular raw material used in Ayurveda,   system shall decide the use of appropriate containers which would protect the quality of raw materials as well as prevent it from damage due to dampness, microbiological contamination or rodent and insect infestation, etc. If certain raw materials require such controlled environmental conditions, the raw materials stores may be subdivided with proper enclosures to provide such conditions by suitable cabinization.
Read: Rasashastra Itihasa (History of Rasashastra)

While designing such containers, cupboard or areas in the raw materials store, care may be taken to handle the following different categories of raw materials:-

1. Raw material of metallic origin.
2. Raw material of mineral origin
3. Raw material from animal source
4. Fresh Herbs
5. Dry Herbs or Plant parts
6. Excipients etc
7. Volatile oils/perfumes and flavors
8. Plant concentrates/ extracts and exudates/resins.

1.1. (F)(B) Packing Materials. – All packaging materials such as bottles, jars, capsules etc. shall be stored properly. All containers and closure shall be adequately cleaned and dried before packing the products.

1.1. (F)(C) Finished Goods Stores. – The finished goods transferred from the production

area after proper packaging shall be stored in the finished goods stores within an area marked

1.1(G) Working space. – The manufacturing area shall provide adequate space

(manufacture and quality control) for orderly placement of equipment and material used in any of the operations for which these employed so as to facilitate easy and safe working and to minimize or to eliminate any risk of mix-up between different drugs, raw materials and to prevent the possibility of cross contamination of one drug by another drug that is manufactured, stored or handled in the same premises.

1.1(H) Health Clothing, Sanitation and Hygiene of Workers.- All workers employed in the Factory shall be free from contagious diseases. The clothing of the workers shall consist of proper uniform suitable to the nature of work and the climate and shall be clean. The uniform shall also include cloth or synthetic covering for hands, feet and head wherever required. Adequate facilities for personal cleanliness such as clean towels, soap and scrubbing brushes shall be provided. Separate provision shall be made for lavatories to be used by men and women, and such lavatories shall be located at places separated from the processing rooms. Workers will also be provided facilities for changing their clothes and to keep their personal belongings.
Read: Collection And Preservation Of Ayurvedic Herbs

1.1. (I) Medical Services: The manufacturer shall also provide:-

(a) Adequate facilities for first aid;

(b) Medical examination of workers at the time of employment and periodical

check up thereafter by a physician once a year, with particular attention being

devoted to freedom from infections. Records thereof shall be maintained.

1.1(J) Machinery and Equipment. – For carrying out manufacturing depending on the size of operation and the nature of product manufactured, suitable equipment either manually operated or operated semi-automatically (Electrical or steam based) or fully automatic machinery shall be made available. These may include machines for use in the process of manufacture such as crushing, grinding powdering, boiling, mashing, burning, roasting, filtering, drying, filling, labeling and packing etc. to ensure case in movement of workers and orderliness in operation a suitably adequate space will be ensured between two machines or rows of machines. These equipments have to be properly installed and maintained with proper cleaning.

1.1(N) Quality Control. – Every licensee is required to provide facility for quality control

section in his own premises or through a Government approved testing laboratory. The test shall be as per the Auurveda  pharmacopoeial standard. Where the tests are not available, the test should be performed according to the manufacturers specification or other

information available. The quality control section shall 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. The quality control section shall have the following facilities: –

1) There should be a 150 sq. feet area for the quality control section.

2) For identification of raw drugs, reference books and reference samples should be maintained.

3) Manufacturing records should be maintained for the various processes.

4) To verify the finished products, controlled samples of finished products of each

the batch will be kept for 3 years.

5) To supervise and monitor adequacy of conditions under which raw materials, semi finished products and finished products are stored.

6) Keep record in establishing shelf life and storage requirements for the drugs.

7) Manufacturers who are manufacturing patent proprietary Ayurveda Siddha, and

Unani medicines shall provide their own specification and control reference in respect of such formulated drugs.

8) 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.

9) The standards for identity, purity and strength as given in respective pharmacopeias of Ayurveda,   systems of medicines published by Government of India shall be complied with.

10) All raw materials will be monitored for fungal, bacterial contamination with a view

to minimize such contamination.
Read: Modern Herbal Pharmacology Vs Ayurvedic Pharmacology

List of machinery, equipment etc.

LIST OF MACHINERY, EQUIPMENT AND MINIMUM MANUFACTURING PREMISES REQUIRED FOR THE MANUFACTURE OF VARIOUS CATEGORIES OF AYURVEDIC, SIDDHA SYSTEM OF MEDICINES.