(To be inserted under Schedule-T - GMP) - amam-ayurveda.org

(To be inserted under Schedule-T - GMP)
Draft GMP Guidelines for Rasaushadhi of ASU medicines
These guidelines are intended to complement those provided in Good
manufacturing practices Ayurvedic, Siddha and Unani Medicines under schedule T of the
Drugs and Cosmetic Rules, 1945 and should be read in conjunction with the parent guide.
The supplementary guidelines are to provide general and minimum technical
requirements for quality assurance and control in manufacturing Rasaushadhi. These
supplementary guidelines deal Bhasma, Sindura, Pishti, Kajjali, Khalviya Ras, Kupipkwa
Rasayan, Parpati, Pottli Rasa, Satwa (of Metals and Minerals origin) Druti Param, Karpu,
and Kushta exclusively.
The GMP guidelines for Rasaushadhi are needed to establish selection and
procurement of authentic raw metals and minerals, in process validation and quality
control, and to achieve quality finished product.
2. Manufacturing Process Areas:-
For the manufacture of Bhasma and Kupipkwa & Rasoushadhi preparations made
from metals and minerals the following specific areas shall be provided
1. Area for Shodhana:- For the Shodhana of materials with Agnisamparka (where
heating involved). - 100 Sq. ft. (Minimum)
2. Grinding Area - 100 Sq.ft. (-do-)
3. Drying area - The area should be dust free. - 100 Sq. ft. (-do-)
4. Puta Area - The area should be well-covered over-roof and airy - 100 Sq.ft.
5. Storage for fuel & Consumable vessels - 100 Sq. ft. (Separate covered area)
The size and dimensions of each Bhatti would be so designed to suit the batch size
or quantity of materials to be processed, keeping in mind the processing is done as per the
conditions of official books mentioned under Schedule I.
In addition to the fuels prescribed in the official texts namely coal, fire wood, cow
dung cakes etc. use of other heating devices namely electrical heating, oil or gas fired
furnaces and others may be employed so as to provide the required temperature.

Depending on the formulation being manufactured, manufacturers may adopt aerobic
or anaerobic process. Properly baked and clean earthen pots and glass containers of
appropriate design should be used.
The manufacturing area should be designed with special attention to processing of
products that generate toxic fumes like SO2, arsenic and mercury vapor etc. When heating
and boiling of the materials is necessary suitable air exhaustion mechanism should be
provided to prevent accumulation of unintended fumes and vapors. Such areas may be
provided with properly designed chimneys or ducts fitted with exhaust system and suitable
scrubbing system to remove fumes and smoke, so that safety of personnel and environment is
taken care of.
Since processing of Rasaushadhi may generate heavy metal contamination and cross
examination, cleaning of equipment is particularly important.
Records shall be maintained specially for temperatures attained during the entire
process of Bhasmikaran while employing furnaces using oil, gas or electricity. Appropriate
temperature measuring instrument should be employed such as pyrograph for manual
reading/recording or heat sensors connected to computer as the case may be.
personal.
Access to manufacturing areas shall be restricted to minimum number of authorized
3. Quality Control:-
A. Process Quality Control:-
The registers as indicated below should exclusively be maintained for ready reference:-
a. Shodhan Register with following details:-
1. S1.No.
2. Batch No. & Size
3. Name of the Raw-material with Quality reference
4. Quantity of Shodhana Dravya

5. Book Reference followed
6. Methodology
7. Description
b. Log Register with following details:-
1. S1.No.
2. Batch No.
3. Quantity of starting materials
4. Quantity of Avapa Dravya
5. Quantity of Bhavana Dravya
6. Date & Time of Starting of Bhavana/mardana
7. Date & Time of completion of Bhavana/Mardana
8. Number of Samputas (Quantity of material in each samputa)
9. Type & Number of Puta
10. Time and Date of ignition
11. Time and Date of evacuation
12. Time and Date of completion of Puta
13. Obtained quantity
14. Colour and texture of the product/Standards
15. In process tests followed.
B. Product Quality Control:-
The specifications for finished Rasaushadhi are primarily intended to define the
quality rather than to establish full characterization, and should focus on those characteristics
found to be useful in ensuring the safety and efficacy. Consistent quality for Rasaushadhi can
only be assured if the starting metals and minerals are defined in a rigorous and detailed
manner. In some cases more detailed information may be needed on aspects of their
collection. The manufacture will ensure in-house standards for the uniform reproducible end
products.
Quality testing will be carried out as per official texts namely colour, taste, varitaratwa,
Rekhapurnatwa, Laghutva, Nirdhumatwa, Dntagre Kachakacha, Niruttha, Apunarbhava and
Nischandratwa.

Wherever possible and applicable Particle size of the product may be tested adopting
microscope fitted with micrometer or particle size analyzer or such other techniques.
4. Product recalls:-
The product recall procedure should be related to and depends very much on the
existing regulation. Standard operating procedures (SOPs) should be included for storage of
recalled Rasaushadhi in a secure segregated area, complying with the requirements
specified for storage, while their fate is decided.
5. Self-inspection:-
At least one member of the self-inspection team should possess a thorough
knowledge on Rasashastra (production and quality control testing of Rasaushadhi).
6. Personnel:-
The release of Rasaushadhi should be under the authority of a person who has been
trained in the specific features of the processing and quality control of Rasaushadhis.
Personnel dealing with the production and quality control of Rasaushadhis should have an
adequate training in the specific issues of Rasaushadhis.
7. Training:-
The personnel should have adequate level of training in appropriate fields such as
Rasa shastra- Bhaishajya Kalpana, pharmaceutical technology, mineralogy, pharmacology of
metals and minerals, inorganic medicinal and pharmaceutical chemistry, Pharmacognosy,
hygiene, microbiology, and related subjects (such as traditional use of herbal medicines).
Training records should be maintained and periodic assessments of the effectiveness of
training programmes should be made.
8. Reference samples and standards:-
In the case of Rasaushadhis, the reference standard may be a mineralogical sample
of the minerals and metals, a sample of the prepared Rasaushadhi, processed metals and
minerals e.g. Bhasma, Kajjali, etc. All reference standards should be stored under

appropriate conditions to prevent degradation. Their expiry and/or revalidation date should
be determined and indicated.
9. Documentation:-
The system of documentation devised or adopted should have as its main objective to
establish, monitor, and record quality for all aspects of the production, quality control and
quality assurance.
10. Stability studies:-
The Rasoushadhis are described as having no specific shelf life. However, inhouse
validation of the product should be done once in 3 years to ensure the desired quality.
Samples used for stability studies should be stored in the containers intended for marketing.
11. Packaging materials and labeling:-
In addition to the Rule 161 of the Drugs & Cosmetics Rules the following
information should be provided in the label. There should be adequate information on the
label (or in package insert) informing the users of the composition of the product (in addition
to the brand name, if any), indications or actions, directions for use, cautions and adverse
reactions if any, and the expiry date.
12. Dosage form of Rasoushadhi:-
In order to have equal quantity of Rasoushadi having different individual doses. the
Rasoushdhi may be made into an acceptable dosage form such as Tablet/Pill/Capsule after
adding suitable fillers or binding agents. In such cases the label must indicate the quantity of
medicine and filling material added in each case. The crystalline product may be grinded
before packing in the individual size.