Rasa ratna samuchchaya have dedicated a separate chapter for rasashala which can be corelated to GMP in present era. It is important to keep in mind that all of these texts were written between the first and the sixteenth centuries. Hence everything is ideally provided in such a description, including the choice of location, water and light facilities, raw material availability, air ventilation, etc. Not only that, but careful consideration is also given to precise and well-considered instructions about staffing levels, financial requirements, and security in various departments in rasashala. Rasamandap in present era mimics the R&D sector. Just as Rasamandap is designated as a confidential and sterile space, the R&D sector similarly emphasizes the importance of maintaining confidentiality in drug development or research works conducted and also aseptic conditions has to be maintained in that sector.

1. SUBJECT SEMINAR
Name: Dr. Vimarsha Bhatkalkar
Designation: 1st year PG Scholar
Institute: KLE Ayurveda Mahavidyalaya &
Hospital
RASASHALA & RASAMANDAPA

2. • Objective
• Introduction
• Nirukti
• Location
• Rasashala interiors
• Rasashala equipment
• Essential people
• GMP
• Rasamandapa
• Rasamandala and kamala Nirmala
• Rasendra pooja vidhi
CONTENTS

3. • To understand the concept of Rasashala.
• To understand the concept of GMP and its importance.
• To understand the concept of Rasamandapa.
OBJECTIVE

4. • In ancient times all the physicians used to prepare their own medicine, they were supposed to know the
preparation methods of various types of medicaments.
• Around 7th century, herbal preparation were used for curative purposes. After this period, the usage of
minerals and metals for therapeutic purposes started. As these minerals could not be used orally in their
mineral/metallic form, they found it necessary to have a specialized technical knowledge for converting
minerals and metals into bhasma. Hence the concept of separate branch of learning known as “Rasa-Shastra”
including the concept of Rasa-Sala and Rasa-vaidyas emerged in the field of Ayurveda.
• Rasashala is the place for manufacturing Rasashastra medicines. Rasashala is always expected to be a quite
hygienic and workable place with all the facilities and have been put up certain rules and regulations for its
establishment under the umbrella of Good Manufacturing Practice now a days.
INTRODUCTION

5. रस = पारद
शाला = भवनम्
शाला is derived from the root word शलगतो
NIRUKTI

6. ACCORDING TO RASATARANGINI ( R.T 1/11-15)
ववमलोपवनप्रदेशगाां रमणीयाां जलयन्त्रशोवभताम् ।
कमनीयगवाक्षसांयुताां जनबादारवितामसक
ु लाम् ।।
वनखिलौषधवगगमखिताां रसवसद्धेश्वरवित्रभूवषताम् ।
ववपुलाखिलसाधनाखिताां रसशालाां ववदधीत शोभनाम् ।।
• The rasashala is constructed in a serene land.
• “Upavana pradesha” means the land selected for construction should be naturally
beautiful with serene and healthy atmosphere and with good fertile soil to grow all the
required herbal drugs.
LOCATION

7. • Jalayantra shobhitam- plenty of water supply should be there.
• Kamaniya gavaksha Sanyukta -The building should be well planned with well ventilated
with wide rooms.
• Janabadharahita ansakulam- The place of pharmacy should be considerably far from the city
and crowd or congested.
• Nikhil aushadha varga mandita -The raw drugs or the finished products drugs should be
neatly arranged with neat labels.
• Rasa sideshwara chitrabhushitam - The central hall of the pharmacy should have the photos
of Lord Shiva, Acharya Nagarjuna and other rasacharya.
CONTD….

9. ACCORDING TO RASATARANGINI (R.T 1/13-15)
शङ्करां पूवगवदग्भागे स्थापयेखिषजाग्रणीीः ।
आग्नेये वविकायागवण याम्ये प्रस्तरक
ृ त्यकम् ॥
शास्त्रक
ृ त्यन्तु नैर्
ग त्ये क्षालनादीवन वारुणे ।
वायव्ये शोषणां शस्त्रमुत्तरे यन्त्ररक्षणम् ॥
वनदध्यादीशकोणे तु रससाधनमूलकम् ।
मुख्योपकरणां तत्तवित्यक
ृ त्यां समागतम् ॥
RASASHALA INTERIORS

11. RASASHALA
VEDHA KARMA
(Conversion of lower
metals into gold)
AUSHADHA
SANGRAHANA
(Storage of raw drugs
and finished products)
RASABHAIRAVA
(Statue of Lord Shiva)
AGNI-
SAMSKARANA
(Boiling, frying,
cooking)
PASHANA KARMA
(Grinding and
pounding)
SHASTRA KARMA
(Cutting, chopping)
KSHALANA
KARMA
(Washing, cleaning)
SHOSHANA
KARMA
(Drying of raw drugs)
NORTH
NORTH-
EAST
SOUTH-
EAST
SOUTH-
WEST
NORTH-
WEST
SOUTH
E
A
S
T
W
E
S
T

12. North Direction
Collection of raw drugs:
• Acharya Charaka in chikitsasthana has mentioned that collection of medicinal plants should be done
from the land of north direction. Medicinal plants of north direction are more potent than south
direction.
• Acharya Sharangadhara (Sha. Prathamakhanda 1/56-57) mentioned that plants growing in north
direction are to be collected for medicinal purpose.
• Also, the ultimate aim for collection of raw drugs will be to obtain the drug in its peak potency
level, (i.e the time of collection of drug). It has been said that the best time for collection of herbs is
Sarad rutu and for drugs of Vamana and Virechana the best time is Vasanta rutu. The drugs
should be collected in the early morning hours. Ushna virya drugs should be collected from
Vindhya hills and Sheeta virya drugs from Himalaya mountains. The drugs could be collected in
fresh form only
WHY SPECIFIC DIRECTIONS?

13. Methods of collection:
• According to Sharangadhara, the drug collection has to be carried out in most systematic and ritual manner.
That is in early hour after bath with calm mind the person should pray to lord Shiva facing the early morning
sun. Later the drugs situated towards north should be collected.
Preservation of the raw drugs:
• Any drug material which is collected should be stored in suitable condition so as to retain the inherent drug
properties until the drug goes into a preparation. For this most primary thing which is required will be the
suitable containers to store the raw drugs and to protect it from getting infected by insects and pest.
North East Direction
• Acharya Charaka mentions that the gate of store room of medicinal plants should be in north east direction. It
has been said so that proper light and air can be reached to the medicinal plants.
North West Direction
• This direction is ruled by the God Vayu who is supposed to control wind blowing. The drying operations of the
drugs if done in this direction will never face blowing wind shortage and will get easily dried with the
blessings of God Vayu.
• Scientifically, the prevailing wind comes from north west direction and then moves towards the east.

14. South East Direction
• The operations related to the use of fire are advised to be carried out in “Agnikona” (South east direction) which is
considered to be ruled by God Agni who by virtue of his being the God of fire keeps control on fire related works
(operations) thus the success in such operations is always expected if such works are performed in this direction.
South West and South Direction
• As this direction is ruled by Rakshasaas (demons) who are cruel in nature and keeps the control of sharp
instruments/ weapons, hence shastra karma that is cutting, chopping, slicing, grounding, pounding etc operations are
done in this direction as it is likely to be completed safely and successfully with the blessings of demons.
East Direction
• The east or north east is considered to be auspicious and is ruled by Lord Indra hence in this direction, statue of
Rasabhairava is installed.
West Direction
• This direction is ruled by God Varuna, who is considered to be the god of water resources, hence washing, cleaning
or any procedures which involves the use of water if done in this direction will never face shortage and gets
completed successfully.

15. RASASHALA – EQUIPMENTS
ACCORDING TO RASATARANGINI (R.T
1/16/25)
ACCORDING TO RASA RATNA
SAMUCHCHAYA (RRS 7/6-13)
Mortar and Pestle made of iron and stone of different
size and shapes
Koshti’s- sattvapatana koshti, bhumi koshti, sura
koshti, chala koshti
Mud pots Water storage tanks
Glass bottles Containers of different sizes
Stainless steel containers 2 bhastrika’s, metallic and bamboo pipes two each
Sandamsha yantra Vessels and utensils- gold, iron, copper, bronze,
leather and stones
Sieves Kandani (small pounder)
Crucibles Peshani (flat stone for rubbing)
Dolayantra and instruments required for dolayantra Droni
Pet jars and glass bottles- finished products Different kinds of mortar & pestle including
taptakhalwa

16. ACCORDING TO RASATARANGINI (R.T
1/16/25)
ACCORDING TO RASA RATNA
SAMUCHCHAYA (RRS 7/6-13)
Dry cow dung cakes Three kinds of sieves.
Woods, husks, grass, ash etc Large knives
Kundali ( circular stands to keep the vessels)
Muds (for preparation of crucibles)
Tusha (paddy husk), cotton, coal etc
Cow dung cakes or cow dung powders
Three kinds of drugs- herbal, minerals, animal origin
Ladles and baskets made of shuki, shanka, kshurapra
Pots and vessels for cooking and heating the medicines
Karnika for cutting the herbs into pieces.
CONTD….

17. CONTD….
SIEVES AND FILTERING INSTRUMENTS (RRS 7/14-17)
The sieves are of three types:
TYPES FEATURES USES
1st type Prepared with thin wires made up of
bamboo and is secured with a thread
Used for filtering coarse substances
2nd type Sieve prepared with bamboo which has
tiny pores
Used for filtering powdered substances
3rd type 4 square inch high circular rim and one
aratni circumference prepared by using
wood of shalmali, karnikara, Khadira. Its
lower portion is covered with hairs of
horse or cloth & tied at the rim by the
means of goats rim.
Used for filtering very fine powders.

18. CONTD….
FUELS AND GLASSWARES (RRS 7/18-22)
Fuels:
1. Shikhitra, pavakochchista, angara, Kokila
2. The burning coal is extinguished not by sprinkling water but by keeping it covered which is
called kokila to prevent the oxygen help in combustion.
3. Cow dung cakes are used as fuel (contains nitrogen,hydrogen,55% methane and 30% carbon
dioxide when used as a biogas).
4. Dry cow dung is also called as pistaka, changana, upala, utpala etc.
Glasswares:
1. Kupika, kupila, siddha, gola- bottles
2. chashaka, katori, vatika, kharika, kancholi and grahika – tumbler
*All these equipments are needed and should be made available and stored in the pharmacy. These are also
worshipped by chanting “ Shri Rasankansha” mantra.

19. ACCORDING TO RASATARANGINI (R.T 1/26-36)
ESSENTIAL PEOPLE
YOGYA PARICHARAKA
LAKSHANA
RASASHASTRA
ACHARYA SWAROOPA
SHISHYA SWAROOPA VARJYA SHISHYA
सोधमा – hardworking सदािार- good conduct सदािार- good conduct दुरािार- who is immoral
सत्यवक्त- truthful सुिररत - good track record सदाशय- noble intentions दुश्चररता- does not have good
track record
वनलोभ- generous समदशाग- non partial स्वक
ु लािरदीवक्षत- should
understand the nature of his
work
अक
ु वलना-does not have any
noble intentions
शुिय- hygiene सदाशय – noble intentions गुरुपूजारत- sincere to teachers मिोद्धता- disobedient
शूर- physically strong सत्यवादी- truthful वीर- brave िौयगच्छलावदना- to cheat
पथ्यावशनो ग्रािा- capable to
understand all his/her
responsibilities.
वसधमन्त्र- highly proficient सत्यवादी- truthful वनत्यां ववद्यग्रिणलोलुपा-
obtaining knowledge through
foul means

20. SHISHYA SWAROOPA VARJYA SHISHYA
शङ्करवप्रय - devotee of lord shiva/god
loving
दृढव्रत- hardworking अज्ञातक
ु लशीला- who’s nature and
background is obscure
धीर वीर- courageous आज्ञापरो- obedient नाखस्तक- atheist
खस्थरप्रज्ञा- who is firm वनरालस्य- active गुरुवनन्दक- does not obey his guru.
रसकमगवविक्षण – one who has good
knowledge on rasashastra
क
ु लीनो अवतवविक्षण- noble
and intelligent
अयुवेदक्र
ु ताभ्यस- who
practices ayurveda
CONTD….

21. ACCORDING TO RASA RATNA SAMUCHCHAYA (RRS 7/23-34)
APPOINTMENT OF
PHYSICIAN
QUALITY OF A
PERSON FOR
COLLECTION OF
RAW DRUGS
PERSON WHO
PREPARES RASAYANA
DRUGS
PERSON WHO
MAKES ALL KINDS
OF INSTRUMENTS
SIDDHI IN
PARADA
KARMA
रससज्जिन्तक वैद्य- one
who has deeply studied
rasashastra
भूतवनग्रिमन्त्रज्ञास्ते योज्या
वनवधसाधने – capable of
eliminating evil spirit by
mantra
वनलोभा- who is not greedy धनवन्तो- rich शुिी- hygiene
निघन्त्तुज्ञास्च- one who has
knowledge about drugs
शुि- hygiene सत्यवक्तारो- truthful वदान्याश्च सवोपस्करसांयुता-
who is experienced in
handling all kinds of
instruments
सत्यवादी-
truthful
सववदेशजभाषाज्ञा- one who
is well versed with all the
languages (nearby)
तत्तदौषधनामज्ञा- one who
has knowledge on
different names of drugs
देवब्राह्मणपूजका- who
worships god and brahman
गुरुवाक्यरता- who takes
advice of his guru
मनखस्वनाम्-
who has
control over
his mind
QUALITIES OF
PHYSICIAN
वञ्चनोखिता- does not
possess jealousy
यवमन- who is always
passioned
सन्देिोखितवि
त्तानाां- who is
not doubtful
धवमगष्ठ- honest नानाववषयभाषाज्ञास्ते- one
who is well versed with
various languages
पथ्यभोक्तारो- who always
follows dietary restrictions

22. वशवक
े शवपूजक- who is a devotee of lord
shiva and vishnu
सत्यवादी- truthful
पद्मिस्तश्च सांयोज्यो- should have lotus
sign on the palm
CONTD….
अदेवशक-unpatriotic
क
ृ पामुक्तो- not cruel
लुब्धो- not greedy
क
ृ ष्णरेिाकरो वैद्यो दग्धिस्त- black
coloured lines on the palm is called as
dagdha hasta

23. DEFINITION
Good Manufacturing Practice is a set of regulations codes and guidelines for the manufacture of active
pharmaceutical ingredient (API), Medical devices in Vivo and In Vitro diagnostic products and food of standard
quality products.
GOOD MANUFACTURING PRACTICE

24. HISTORY
Year Milestone
1920 No rules were existed in India
1920 Substandard drugs without testing were available in Indian market
1927 Council of state submitted the report to governer general. Governer general requested to control the irregular drug
production and to maintain the SOP but unfortunately it did not happen. So around 1930, Indian practitioners boycotted
the substandard manufacturing to look into this. Then drug enquiry committee was constituted. The drug enquiry
committee took steps to control & regulate adulterated and substandard drugs.
1940 Indian drug Act was passed on 10th April
1941 GMP was initiated
1948 Indian pharmacopeia committee was constituted. Pharmacy act 1948 was published.
1955 First edition of IP was published. Quality, strength and purity were mainly stressed in IP
1963 Establishment of GMP’s for drugs
1962 Drug and Cosmetic Act was formed
1963 FDA issued 1st guideline in June
1964 Ayurveda, unani and siddha were bought under the purview of D & C Act
2000 GMP was enforced

25. • Schedule T is for AYUSH Drugs
• Schedule T has three parts:
Part 1: Deal with location, premises, buildings and 4 M’s namely Manpower, Material, Machinery and Method
etc.
Part 2: Deals with documentation
Part 3: Deals with qualification and validation

26. PART 1

27. LOCATION IMPORTANCE ACC. TO AYURVEDA
• It should be situated and constructed
away from open sewage, drain, public
lavatory.
• Away from any factory.
• Availability of suitable, quality of
potable water
• Availability of electricity and power.
• To avoid contamination from open
drain, sewage or public lavatory.
• Away from any factory which
produces disagreeable or obnoxious
odour or fumes or excessive dust or
smoke.
• RT- The rasashala should be
constructed in Upavana pradesa (and
with good plantation and fertile soil)
and in janabadharahita, asankulam,
nikhil aushadha varga sanyukta
(having various and plenty
medicines).
• RRS – sarvabadha vivarjita (devoid
of any problem), sarva aushadhamaya
desha (having plenty of medicinal
plants.
WATER SUPPLY & DISPOSAL OF
WASTE
IMPORTANCE ACC. TO AYURVEDA
• Water should be pure and of potable
quality.
• Adequate provision of water for
washing the premises.
• Provision for waste disposal should
be made properly.
• In order to avoid microbial
contamination.
• To maintain a high degree of
hygiene in the manufacturing area.
• RT – jala yantra shobhitam ( plenty
of water supply)
• RRS - kupa samanvita (plenty of
water supply), ramye (pleasant
environment)

28. BUILDING IMPORTANCE ACC. TO AYURVEDA
• It should be free from
insects/rodents.
• Should have adequate
light(minimum recommended
intensity of light is 500 lux),
ventilation and space.
• Ceiling should be smooth
• Floor and wall should be smooth.
• Appropriate porosity filters- HEPA (
High Efficiency Particulate Air
Filters) in aseptic areas.
• To prevent contamination
• In order to permit easy cleaning and
disinfection the interior surface
should be smooth and free from
cracks.
• To permit retention or accumulation
of dust or waste product the flooring
should be smooth and even.
• RT - It should be kamaniya
gavaksha asankulam (not congested
and properly ventillated)
• RRS– (ventillated with proper
doors and windows), suvistirna
(spacious), aatanka rahita deshe
(free from violence either animal or
human).
Category
of
Medicine
Minimum
manufactu
ring
space
required
Machinery/ Equipment recommend
Anjana/Pisti 100 sq. feet Khalva/end runner/ ball-mill sieves/shifter
Churna,
Kwatha
200 Sq.feet Grinder/ Disintegrator/ Lepa Pulverize/ Powder mixer/ sieves
Pills/Vatti/G
utika
Tablets
100 sq.feet Ball mill, mass mixer powder mixer pill/vati cutting machine, stainless steel
trays/ containers for storage. driers
Kupi pakva/
Ksara/Parpa
ti/ Lavana
Bhasma
satva
150 sq.feet Bhatti,Stainless steel vessels/ flask, Multani matti/plaster of paris,/copper
rod, earthen container, muffle furnace(electrically operated) end/edge
runner, exhaust fan, wooden spatula
Kajal 100 sq.feet Earthen lamps for collection of kajal, tipple roller mill, end runner,
sieves, filling/packing and manufacturing room should be provided with
exhaust fan & ultra violet lamps.

29. CONTAINERS & STORES IMPORTANCE ACC. TO AYURVEDA
• Containers such as bottles, vials and
jars are properly washed, cleaned,
and dried.
• It should be stored properly.
• Storage area should have proper
ventilation.
• Different storage area should be
maintained for Raw material,
Packaging material and Finished
product.
Container’s Cleaning:-
• To avoid any foreign body
contamination.
• Drying is done to prevent the
damage of the substances which are
stored.
Storage area:
• Free from dampness and having
proper ventilation to protect the raw
material from any microbial
contamination and insect infestation.
• It should have an adequate space to
protect from mix-up of raw material.
RRS (7/18-22)- All equipments
required for pharmacy from cleaning to
preparation should be available and
stored in pharmacy.

30. RAW MATERIALS IMPORTANCE ACC. TO AYURVEDA
• It should be stored properly
• Good quality raw material should be
selected.
• Protected from microbial
contamination.
• Proper environmental condition
should be maintained.
• It should be stored under different
categories like the Raw material of
metallic origin, Raw material of
mineral origin, and Raw material of
animal origin, Fresh herbs, Dry herbs
and plant parts.
• Rejected raw drugs should be kept in
separate rooms
• To prevent it from damage due to
dampness, microbial contamination
or rodent and insect infestation etc.
• Each container used for raw material
storage shall be properly identified
which indicates name of the raw
material, source of supply and will
also clearly state the status of raw
material such as “UNDER TEST” or
“APPROVED” or “REJECTED”
• The batch No. and date of receipt
should be mentioned.
• All the raw materials shall be
sampled and should be tested by the
laboratories approved by Govt. for
authentication, morphological or
Organoleptic evaluation, microscopy
and chemical evaluation.
• Sharangadhara (Sha.
Prathamakhanda 1/58) – Drugs
which are spoiled by insects, fire,
cold etc are not to be used.
• Charak Samhita (kalpasthana) –
the drugs collected by proper method
should be stored in a place which is
free from direct breeze, fire, water,
dampness, dust etc and also insects
and animals. It should also be stored
in proper containers.

31. FINISHED PRODUCTS IMPORTANCE ACC. TO AYURVEDA
• Only approved materials are used.
Labels are examined for identity
before labeling operations to avoid
mix-up.
• Packages of finished products bear
permanent code marks.
• Packaging materials such as bottles,
jars, capsules shall be stored properly
with an absorbent in each container.
• All containers and closure shall be
adequately cleaned and dried before
packing the product.
• Dispatched as per market needs.
• The finished product are transferred
in finished good stores within an area
and marked as “Quarantine”
• After getting clearance from QC
laboratory the final product is
moved to “Approved Finished
Goods stock”
• To ensure quality, safety and efficacy
of complex products of biological
origin such as herbal medicines.
• To avoid any contamination and
damage of the final product it should
be cleaned and dried properly.
• Should not mix-up with Finished
product and Approved Finished
product.
RRS (7/18-22) - all equipments required
for pharmacy from cleaning to
preparation should be available and
stored in pharmacy.

32. WORKING SPACE IMPORTANCE ACC. TO AYURVEDA
• Adequate space should be provided
for orderly placement of equipment.
• Adequate space should be provided
for material which is useful to carry
out the procedures and also to
facilitate easy and safe working.
• The manufacturing area shall
provide adequate space to minimize
or to eliminate any risk of mix-up
between different drugs.
• To prevent the possibility of cross
contamination of one drug by
another drug that is manufactured,
stored or handled in the same
premises.
• RT and RRS provided specific
directions to carry out various
procedures.
CLOTHING AND HYGIENE IMPORTANCE ACC. TO AYURVEDA
• Proper uniform shall be given.
uniform shall also include cloth,
covering for hands, feet and head.
• Adequate facilities for personal
cleanliness.
• Provide facilities for keep their
personal things.
• To protect from infectious diseases,
or skin diseases of personnel and
from contacts with toxic irritants.
• RT and RRS have mentioned the
ideal qualities of attenders.

33. FIRST AID METHODS IMPORTANCE ACC. TO AYURVEDA
• First aid methods should be
provided.
• Periodical medical examination of
the workers is mandate
• It is done to keep away from any
kind of diseases or infections.
• RT mentions under qualities of
paricharaka that he/she should be
clean, hardworking etc..
EQUIPMENTS IMPORTANCE ACC. TO AYURVEDA
• Suitable equipment either manually
operated or operated semi-
automatically or fully automatic
machinery shall be made
available.
• These equipments have to be
properly installed and maintained
with proper cleaning.
• Space should maintained b/w two
machines for easy movement of
worker.
• To prevent pest-infestation or
microbial contamination and cross
contamination, cleaning of
equipment is particularly important.
• The equipment should be dried
immediately after cleaning in
order to avoid the growth of
microorganisms.
• RRS (6/6-23)- mentions all the
different types of equipments,
furnaces, fuels etc required for
pharmacy
• RT (1/18-27)- mentions the same as
RRS.

34. BATCH MANUFACTURING RECORDS IMPORTANCE
• Maintain batch manufacturing record of all types of
product.
• List of raw materials, quantities and various tests
with record should be maintained.
• Record of quality control and Record of manufactured
drug to finish product to be maintained.
Only after verified and accepted quality it is cleared for
sale.
• Manufacturing records are required to provide an
account of the list of raw materials and their
quantities obtained from the store.
• Tests are conducted as per First Schedule of the Drugs
and Cosmetic Act, 1940.
DISTRIBUTION RECORDS IMPORTANCE
• Record date, manpower, machines and equipments
should be maintained.
• Record of sale and distribution of each batch of
medicine shall be maintained.
• It is maintained in order to facilitate prompt and
complete recall of the batch, if necessary.

35. LABELLING IMPORTANCE
Should contain:
• Name of the product.
• Reference
• Statements of identity and net contents
• Address of the manufacturing product.
• Manufacturing date and date of expiry.
• Shelf life
• Any direction for safe use of product
• It should provide the general knowledge about the final
product regarding the ingredients, quantity of ingredient,
referencing of the product.
RECORD OF MARKET COMPLAINTS IMPORTANCE
• Maintain a register to record market complaints received
regarding the products sold in the market.
• All the data of investigation regarding the complaint
should be registered.
• Once in six months report should be submitted to
licensing authority.
• Helps to find out Adverse Drug Reaction
• Helps in W.H.O guidelines on safety monitoring of
herbal medicines in pharmacovigilance systems.
QUALITY CONTROL IMPORTANCE
• Each manufacture shall provide facility for quality control
in their premises
• The Quality control section shall verify all the raw
materials regarding identity, purity, fungal, bacterial
contamination, monitor in process, quality checks and
control the quality of finished product being released to
finished goods store house.

36. MAN POWER
The responsibilities of production chief are:
1. Approval of instructions related to production operations including in process controls and their
implementations.
2. Checking the maintenance department premises and equipment.
3. Ensuing process validations, control equipment calibrations and maintenance of records.
4. Ensuing production and storage of products according to appropriate documentation.
The responsibilities of quality control chief are:
1. Approval or rejection of starting materials, packing materials, intermediate, bulk and finished products.
2. Evaluation of batch records ensuring all tests, approval of sampling instructions, specifications, test
methods and other QC procedures.
3. Checking and maintenance of the department, premises and equipment.
4. Ensuring the validation of quality control procedures and records keeping.

37. PART 2

38. All the work carried out in the premises has to be documented and should be
checked by the experts of the field regularly and reviewed with concerned
persons. No document should be changed without authorization of appropriate
authority. Any correction in the record should be initiated.
1. Raw material records • Raw materials
• Finished products
• Packing material of their receipt and issue of disposal
etc are to be maintained.
2. Productions unit • Master formula records
• In process control records like size reduction, sifting,
mixing, granulation, drying etc
• Batch production records
• Weight variation and volume variation records
• Drug release records
• SOP records
3. Quality control records
4. Distribution records
5. Sales tax, excise duty etc records

39. RESEARCH ARTICLES

40. REFERENCE (R.R.S 6/14-16)
• Rasamandapa should be constructed in a plain, secret and concealed area.
• It is secured from pillars, big doors and closures and to be decorated with flags, umbrella and garlands of
flowers.The floor of the rasamandapa should be strong and polished.At the centre of this mandapa, and
arrangement should be made for Rasa Linga.
RASAMANDAPA

41. PREPARATION OF RASA LINGA (R.R.S 6/17-18)
CONTD.…
1 part of
Swarna
patra + 3
parts of
parada
Bhavana with amla
Dravya for 3 hours
When solidifies,
linga of lord shiva is
made
Dolayantra
swedana with
jambira nimbu
swarasa/kanji
To be placed at
the centre
platform of
rasamandapa

42. REFERENCE (R.R.S 6/43-46)
• The disciple should enter the pharmacy which is cleaned and smeared with cowdung.
• Hexagonal mandala is drawn measuring 2 hasta Pramana with the help of sindura.
• With the same sindura, 8 petalled lotus, 4 corners and 4 entrances is drawn outside (above mandala). In the
centre of the lotus, iron khalva decorated with golden lines is installed and in this 25 pala, 50 pala and 100
pala of purified parada is placed and worshipped.
RASA MANDALA &
KAMALA NIRMANA

43. • When all the drugs are placed, the drug are worshipped by chanting Aghora Mantra.
• After the preparation of Rasa Mandala and 8 petals lotus, they are set at the four entrances.
• Rasa linga should be established at the centre of the lotus and worshipped with shodashopachara.
• The ritual deeds are explained in detail in Anandakanda Amritikarana Vishranti Ullasa - 2
RASENDRA POOJA VIDHI

44. • Rasa ratna samuchchaya have dedicated a separate chapter for rasashala which can be corelated to GMP in
present era.
• It is important to keep in mind that all of these texts were written between the first and the sixteenth
centuries. Hence everything is ideally provided in such a description, including the choice of location, water
and light facilities, raw material availability, air ventilation, etc. Not only that, but careful consideration is
also given to precise and well-considered instructions about staffing levels, financial requirements, and
security in various departments in rasashala.
• Rasamandap in present era mimics the R&D sector. Just as Rasamandap is designated as a confidential and
sterile space, the R&D sector similarly emphasizes the importance of maintaining confidentiality in drug
development or research works conducted and also aseptic conditions has to be maintained in that sector.
CONCLUSION

46. THANK YOU