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RASASHALA IN
ACCORDANCE WITH GMP
By: Dr.Anusha Baseganni.
1st year PG Scholar
Dept. of RSBK
AMV HUBBALLI
CONTENTS
1. Introduction to Rasashala
2. Word meaning
3. Four components of Rasashala
4. Rasamantapa
5. Guna’s of Rasavaidya,Sishya,Paricharaka & kalini stree
6. GMP
7. Recommendations of GMP
8. Research article
9. Discussion
10. Conclusion
INTRODUCTION
• Ayurveda mainly aims at Swastha Rakshana an Rogi Chikitsa for which chikitsa
chatuspada ie.[Bhisag,Rogi,Aushadha & upastha]plays an important
role
• Aushadhi acts as tool for Vaidya in eradicating the Roga
• For preparation of such Aushadhi the special place is built by our Acharyas in
ancient period Known as Rasashala which is dealt under Rasashastra and
Bhaishajya kalpana.
• Acharya’s concentrated not only on the construction,but also on interior plans ,
arrangements, appointment of skilled attendants for different sections of
Rasashala
• Rasashala/Rasayanashala/ Bheshajagara,/Aushadha nirmana kendra or pharmacy
is always expected to be clean and hygiene and workable place for all facilities and
it is put up with many rules and regulations for establishment under the concept
of GMP now a days
• GMP deals with all the aspects from collection of raw drug till the dispensary of
final product
• Though the concept of GMP came into existence recently, the concepts related to
this can be found in the samhitas of Ayurveda many years back.
WORD MEANING OF RASASHALA
• RASA-PARADA
SHALA-BHAVAN ;the word shala is derived from root word
‘shalgatho’
शाला तरूस्कन्दशखा शाला भवनमिष्यते।
• The word Rasashala was first mentioned in Rasendra Chudamani
• The term Rasashala denotes the place wherein different processes
pertaining to Rasa[Parada] and other Rasa dravyas are carried
out
FOUR IMPORTANT COMPONENTS
OF RASASHALA
1. Sthana
आतङ्क रमिता देशे धिमराज्य िनोरिे।
उिा ििेश्वरोपेते सिृद्धे नगरे शुभे।।|
कतमव्य साधनि् तत्र रसराजस्य धीिता।
[R.R.S 611]
STHANA BHAVANA
ADIKARI
EVAM
KARMACHAR
I
KARYAVIB
HAJANA
1. According to Rasendra Chudamani 3/1,2
• Sarvabadavivarjitha
• Sarva aushadhi mahe deshe
• Ramye
• Kupasamanvithe
2. According to Rasatarangini 1/13
• Vimalo upavana pradeshe
• Ramye
• Jalayantra shobhete
• Kamaniya gavaksh samyukta
• Nikila aushadha varga mandala
• Janabhada rahita sankulat
• Rasa siddheshwara chitra bushithe
3. According to Ananda Kanda 2/22
• Asthika prani subage.
• Su rakshithe dware naranga ,dadima,jambhira,nimba, tala,hintala,
bakula,amla,patola,ashoka etc.
BHAVANA NIRMANA
• [Ref: R.R.S 6/12]
1. ATYANTA UPAVANE
2. CHATHURDWARA UPASHOBITE
3. SUVISTIRNA
4. SAMYAK VATAYANAPETE
5. DIVYA CHITRA VICHITRITAHA
KARYAVIBHAJANA
RASASHA
LA
RASABHAI
RAV
SIDDHAVAS
TU
VEDHA
KARMA
PASHANA
KARMA
AGNIKARM
A
SHOSHAN
A
KARMA
KSHALAN
A KARMA
SHASTRA
KARMA
PURVA(E)
DA
KS
HINA(S)
PASCHIMA(w)
UTTARA(N
)
ADHIKARI EVAM KARMACHARI
ADIKARI
1. RASAVAIDYA
2. DHATUVADA SADAKA[Minerologist]
3. RASAYANA SADAKA[pharmacologist]
4. BAHUBASHYAKARA[linguist]
KARMCHARI
1. AUSHADA SANGRAHAKARTA [Drug collector]
2. RASAKARTA SAHAYAKA[Pharmacy assistant]
3. BALI SADAKA[Security guard]
4. PARICHARAKA[Attender]
GUNAS OF RASA VAIDYA
[Ref- R.R.S 6/3-4]
1. JNANAVAN
2. DAKSHA
3. RASASHASTRA VISHARADA
4. MANTRA SIDDHA
5. MAHAVEERA
6. NISCHALA
7. SHIVAVATSALA BAKTHA
8. SADHADEERA
9. DEVATA ACHARYA TATPARA
10.SARVA KUSHALO RASA KARMANI
SISHYA GUNA
YOGYA AYOGYA
1. Guru bhaktha 1. Nasthika
2. Satyavanta 2. Durachara
3. Sadhachari 3. Chumbaka
4. Drudavruta 4. Guruto apara
5. Niralasya 5. Vidya grahito michanti
6. Dharmagnya 6. chaurya
7. Sadha agnya paripalaka 7. Na Sidhayet
manimatraaushdhikam
8. Dambha matsarya nirmuktha 8. Eha loka sukam paraloka cha
9. Kula acharya dakshita
10. Atyantha sadhaka
11. Shanta
[Ref- R.R.S 6/5-
6]
PARICHARAKA GUNA
1. SA UDYAMA
2. SISHYASTHE
3. KULINA
4. SWAMI BHAKTHA
5. SHUCHI
6. SHURA
7. BALISTHA
KALINI STREE
[Ref-R.R.S 6/33-37]
• She represents the goddess parvati and attained Rutu chakra in krishna
paksha
• Characteristics of kalini stree
1. Kinchita keshya
2. Shyama padma lochana
3. Surupa
4. Taruni
5. Mrudhu bhasini
6. Ashwatha patra sadrusya yoni
• Kalini stree abava- 1 karsha shuddha gandhaka with go ghrita for 3
saptaha .Then she will attain the qualities of kalini stree
• Importance of kalini stree- success in Rasabandha and other Rasayana
kriya
RASAMANTAPA
• Rasa Mantapa ia the unique place & platform which is constructed for
placing and worshipping Rasa Linga. It should be constructed within the
rasashala in the eastern direction
• It should posses shat kona , asta dala kamala
• Samatala
• Atigupta ,suvistirna
• Should possess large arches and gates
• The upperpart of Rasamantapa ia attaches with dwaja and chatra
• Decorated with pushpa and mala
• There be ringing sounds of beri,kahala, shrunga, ghanta
• In the centre Rasa Linga is placed , and other rasa dravyas are placed in
systemaic order , worshiping of Rasa Linga is carried by chanting the
Agora mantra and Rasankushi mantra
RASALINGA
• [Ref: R.R.S 6/17]
• Swarna patra - 3 Niskha
Suddha Parada- 9 Nishka
Bhavana dravya -nimbu swarasa for 1 yama kala further subjected to
swedhana in dolayantra with jambira rasa or kanji for 1 day
Importance of Rasa Linga
• Regular worshipping of rasalinga should be done by chanting Agora and
Rasankushi mantra to attain prosperity and to get rid of paap mukti
• Equvalient to worshipping one thousand crore shiva Linga & and siddhi
in all rasa kriya
INSTRUMENTS & EQUIPMENTS
REQUIRED FOR RASASHALA
• [Ref:R.R.S 7/6-13]
1. Kostiyantra-satvapatanakosti,bhumikosti,chalakosti,patalakosti etc
2. Water storage tanks and containers of different sizes
3. Bhastrikas- 2[blowing bellows]
4. Metallic pipes-2,bamboo pipes -2
5. Kunda[vessels]-prepared with gold,silver,iron,copper,bronze,stone,leather
6. Kandani[small pounders]&peshini of different varietes
7. Droni(water tubs) ,khalwa yantra ,perhani of different sizes
8. Sieves
9. Chalani,shalaka and kundali (circular stands)
10. Mrittika for preparation of mushas( sweta,krishna,valmiki mritika)
11. Tusha(husk) ,karpasa(cotton),pistaka (dough)
12. Raw material for preparation of medicine [herbal,mineral,animal origin]
13. shikitra(coal),upala,valuka
14. Varaka[bottle] –made up of kacha,mritrika
15. Different Patra of different kinds for heating boiling etc.
GMP
• Good Manufacturing Practices is a set of legal guidelines that have
been regulated by W.H.O since 1975. It aims to ensure that drugs and
other pharmaceutical products are safe and effective
• History of GMP-The GMP was first introduced in NASA in rocket
technology, named as zero defect.
• In India, GMP was introduced in 1988 as an amendment to Drug and
Cosmetic rule 1945. In India licenses for manufacture of ASU drugs
are issued only which fulfill the GMP requirement
• Definition- A good manufacturing practice (GMP) is one that conforms
to the guidelines set by the regulatory agencies that control
authorization and licensing for the production and sale of food,
beverages and active pharmaceutical products.
RECOMMENDATIONS OF GMP
Factory premises:
• Receiving & storing of raw material
• Manufacturing process areas
• Quality control section
• Finished goods store
• Office
• Rejected goods/drugs store
1. Factory premises
2. Guidelines of GMP
GUIDELINES ACCORDING TO GMP
1. Location and Surrounding
2. Building
3. Water supply and disposal of waste
4. Containers cleaning and stores
5. Raw material
6. Production
7. Packaging materials and finished goods stores
8. Working place
9. Clothing and Hygiene
10. Medical services
11. Equipment
12. Batch manufacturing records
13. Distribution records
14. Labeling
15. Records of market complaints
16. Quality control
1.LOCATION AND SURROUNDINGS
• Away from open sewage, drain, public lavatory & factory , To avoid
contamination
• And to prevent from disagreeable or noxious odour or fumes or excessive dust
or smoke.
2. BUILDING
• Free from insects/rodents.
• Adequate light, ventilation and space.
• Floor and wall should not be moist.
• According to provision of factory act
• Should permit easy cleaning and disinfection , the interior surface should be
smooth and free from cracks
• proper drainage system in the processing area .the sanitary fitting and
electrial fixtures should be proper & safe
• There should be fire safety measures & emergency exits
3. WATER SUPPLY AND DISPOSAL OF WASTE
• Pure and of potable quality
• Adequate provision of water for washing the premises
• Provision for waste disposal should be made properly to
avoid microbial contamination. And high degree of
hygiene in the manufacturing area
4. CONTAINERS CLEANING AND STORES
• Containers such as bottles, vials and jars are properly
washed, cleaned, and dried.
• stored properly
• Storage area should have proper ventilation &free from
dampness
• Different storage area should be maintained for Raw
material, Packaging material and Finished product.
5. RAW MATERIALS
• stored properly
• Good quality raw material should be selected & protected from microbial
contamination
• stored under different categories like the Raw material of metallic origin, mineral
origin, animal origin, Fresh herbs, Dry herbs and plant parts.
• Each container used for raw material storage shall be properly identified by name
of the material, source of supply and status of the of raw material such as
„UNDER TEST‟ or „APPROVED‟ or „REJECTED‟
• All the raw materials shall be sampled and got tested by the laboratories
approved by Govt. for authentication, morphological , Organoleptic evaluation,
microscopy evaluation, chemical evaluation
•
6. PRODUCTION
• Only approved materials are used.
• Samples are taken, as appropriate, during or after processing, transfer or filling
for testing.
• Packages of finished products bear permanent code marks, to ensure not only
quality, but also safety and efficacy of complex products of biological origin, such as
herbal medicines, it is essential that their production is clearly defined
7. PACKAGING MATERIALS AND FINISHED GOODS STORES
• Packaging materials such as bottles, jars are stored properly.
• All containers and closure should be adequately cleaned and dried
before packing the product.
• The finished goods from the production area after proper packing are
stored in finished goods stores marked as“Quarantine”
• After the quality control laboratory experts have checked the finished
goods and then it is moved to “Approved Finished Goods Stock” area.
Only approved goods are dispacted as per marketing requriements.
8. WORKING SPACE
• Adequate space for orderly placements of equipments & material.
• To minimize or to eliminate any risk of mix-up between different drugs,
raw materials to prevent the cross contamination of one drug by
another drug that is manufactured, stored or handled in the same
premises should be prevented
9. CLOTHING AND HYGIENE
• Free from contagious disease .
• clothing for workers consistes of proper uniform suitable according to nature of work
& climate
• The uniform also include cloth or synthetic covering for hands, feet and head
wherever neccesary
• Adequate facilities for personal cleanliness such as clean towels, soap and
scrubbing brushes are also provided
• Seprate provision for lavatories used by men & women ,& located seprate from
processing rooms.
• seprate sections for keeping their personal belongings & for changing clothes
•
10. MEDICAL SERVICE
Manufacturer shall provide:
• Adequate facilities of first aid
• And during the time of employment & periodical medical examination to workers.
• It is done with particular attention keeping all the safety measures to avoid the
spreed of infections.
• And Records should be properly maintained
11. EQUIPMENT
• Suitable equipment depending on the size & nature of production either
manually ,semi-automatically or fully automatic machinery are made
available
• Different machines for crushing, grinding, powdering, boiling, mashing
,filtering, labelling etc.
• Properly installed and cleaned periodcally
• Space should be maintained b/w two machines for easy movement of
worker.
• Dried immediately after cleaning to avoid growth of microorganisms
12. DISTRIBUTION RECORDS
• Record date, manpower, machines and equipments should be maintained.
• Records of sale and distribution of each batch of ASU medicine shall be
maintained in order to facilitate prompt and complete recall of the batch,
if necessary
13. BATCH MANUFACTURING RECORDS
• The licence should be maintain for each batch of ASU drugs manufactured irrespective of type of the
product
• List of raw materials, quantities and various tests with record should be maintained.
• Record of quality control to finish product should be maintained
• Only after the manufactured drugs have been verified and accepted shall be allowed for sale.
• Tests conducted during the various stages of manufacture like taste, colour, physical characteritics
& chemical test is necessary as mentioned in the First Schedule of the Drugs and Cosmetic Act,
1940.
14. RECORD OF MARKET COMPLAINTS
• Manfactures shall maintain a register to record of market complaints received regarding the
products when sold
• Reports of adverse reaction resulting from use of ASU drug shall also be maintained in seprate
record by each manfacture
• Once in six months the reports should be submitted to licensing authority.
• The manufacturer shall investigate any of the adverse reaction if found , due to any defect in the
product, and whether such reaction are already reported earlier or it is new observation.
14. LABELING
The label on outer container should bear -
• Name of the product.
• Statements of identifications and net contents,
• Address of the firm manufacturing unit
• General information about the product regarding the ingredients, quantity
of ingredient, reference of the product.
• self life, date of manufacturing, & date of expiry
• Any contraindication of particular product
16. QUALITY CONTROL
• Each manufacture shall provide facility for quality control section in their
premises or through government approved testing laboratory .The test shall
be as per the ASU pharmacopeia standard
• Quality control section shall verify all raw materials, quality of finished
product.
• Quality control should have separate expert.
It should have fallowing facilities :
1. Should be 150 sq.feet
2. For identification drugs, reference books & samples should be
maintained
3. To verify the finished products, samples of finished products of each
batch will be kept for 3 year
4. Manufactures of ASU medicines shall provide their own specification &
control referances in respect of such formulated drugs
5. The record of specific procedures such as “Bhavan”, “Mardana” &
“puta” shall be maintained
6. The standards for identification, purity,and strength as given in
respective pharmacopoeia of ASU system of medicines published by
government of india shall be complied
7. All raw materials are monitored for fungal,bacterial contamination
with a view to minimise such contamination
8. [a] one person with degree qualification in ASU as per schedule 2 of
MEDICINE CENTRAL COUNCIL ACT 1970
MINIMUM MANUFACTURING
PREMISES REQUIRED FOR THE
MANUFACTURE OF AYURVEDIC
MEDICINES
CATEGORY OF MEDICINE MINIMUM MANUFACTURING
SPACE REQURIED
1. Arka, pills/vati/gutika, ointment ,
capsule,Anjana/Pisti ,Tila,ghrita
100 Sq.feet
2. Kupi pakva/Ksara/Parpati/Lavana
Bhasma/satva/sindura/karpu/
avaleha/khand/modaka/panak/syrup/
kwath
150 Sq. feet
3. churna/nasya
manjan/lepa/asava/arista/
kwathchurna
200 Sq.feet
COMPARISIONS BETWEEN
RASAMANTAP AND GMP
• As Ayurveda origined from the vedic period they belived more on
divinity so worshipping of Rasalinga has been given prime importance ,
where as in GMP they is no such referance about worshipping god
• Rasashala ia mainly built on vastu shastra , but according to GMP
premises are built according the guildlines and convinience
• In Rasashala placement of instrunment & processes pertaining to
parada & other Rasa dravya are done in 8 direction keeping view of
asta dikh palakas where as in GMP they concentrated only on the
infracuture
• In Rasashala , particular characteristics for appointment of
Rasavaidya, Sishya,Parichara and kalini stree is mentioned where as
in GMP appointments are done only on qualifications of individual
RESEARCH ARTICLE
conclusion
• GMP is an essential and significant step
taken by the Government in improving
the quality and standard of ASU drugs
being manufactured in about 9000
licensed ASU pharmacies in our country.
In the similar way our ancient Acharyas
were much more concerned about
minutest parts of the
bhesajagara/rasasala. In almost every
classical text of Rasashastra usually a
separate chapter is devoted in describing
building of a production unit. In such
description right from selection of the
place, to accurate and well thought of
directions regarding various
departments section and staff, financial
requirements and security are also
given. It must be remembered that all
these texts date back to a period
between 1st to 16th centuries. It
therefore need not be stated that the
description are as per need of the period,
DISCUSSION
• Acharyas were very much concerned about minutest parts of the
rasasala. They concentrated not only on the construction of the
manufacturing unit but also on the selection of place for construction,
interior plans and arrangement etc.
• The building, water supply, disposal of waste, containers cleaning and
stores, etc are similar to those mentioned in Ayurveda.
• For working Space, different sections are mentioned for agni karma,
sastra karma, kshalana karma etc which are related to vastu shastra.
• The different equipments mentioned in samhitas for Rasashala are
according to the materials avaiable, quantity of medicine manufactured
and the type of medicine prepared during those days.
• With times, advancement in science, growing demand of medicines these
instruments have been replaced by more sophisticated machinaries which
can meet the demands of the society in a short span of time.
• Acharyas were very well aware of the quality and hence mentioned about
dravya sangrahana and dravya samrakshana vidhi which assured good
quality of the medicines.
CONCLUSION
• In Rasashala, medicines are prepared according to classics and in
traditional way
• In GMP certified pharmacy, medicines are prepared in bulk.
• Concepts of GMP were followed from the vedic period and the
references can be seen in ayurvedic textes which have given elaborate
description about the Rasashala and also about the production of
medicine
• To meet the worldwide demand for herbo-mineral drugs ,it is
essential to maintain GMP
• Implementing GMP for herbo-mineral drugs, as per the recent
amendment of the DRUGS AND COSMECTIC ACT of the
government of india with a buffer period of two years,is a great
challenge for ayurvedic drugs.
• Recently Govt. of India has notified GMP for ISM .this is also aimed
to ensure production of good quality medicines for the consumer in
the domestic & international market.
THANK YOU

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RASASHALA IN ACCORDANCE WITH GMP....pptx

  • 1. RASASHALA IN ACCORDANCE WITH GMP By: Dr.Anusha Baseganni. 1st year PG Scholar Dept. of RSBK AMV HUBBALLI
  • 2. CONTENTS 1. Introduction to Rasashala 2. Word meaning 3. Four components of Rasashala 4. Rasamantapa 5. Guna’s of Rasavaidya,Sishya,Paricharaka & kalini stree 6. GMP 7. Recommendations of GMP 8. Research article 9. Discussion 10. Conclusion
  • 3. INTRODUCTION • Ayurveda mainly aims at Swastha Rakshana an Rogi Chikitsa for which chikitsa chatuspada ie.[Bhisag,Rogi,Aushadha & upastha]plays an important role • Aushadhi acts as tool for Vaidya in eradicating the Roga • For preparation of such Aushadhi the special place is built by our Acharyas in ancient period Known as Rasashala which is dealt under Rasashastra and Bhaishajya kalpana. • Acharya’s concentrated not only on the construction,but also on interior plans , arrangements, appointment of skilled attendants for different sections of Rasashala • Rasashala/Rasayanashala/ Bheshajagara,/Aushadha nirmana kendra or pharmacy is always expected to be clean and hygiene and workable place for all facilities and it is put up with many rules and regulations for establishment under the concept of GMP now a days • GMP deals with all the aspects from collection of raw drug till the dispensary of final product • Though the concept of GMP came into existence recently, the concepts related to this can be found in the samhitas of Ayurveda many years back.
  • 4. WORD MEANING OF RASASHALA • RASA-PARADA SHALA-BHAVAN ;the word shala is derived from root word ‘shalgatho’ शाला तरूस्कन्दशखा शाला भवनमिष्यते। • The word Rasashala was first mentioned in Rasendra Chudamani • The term Rasashala denotes the place wherein different processes pertaining to Rasa[Parada] and other Rasa dravyas are carried out
  • 5. FOUR IMPORTANT COMPONENTS OF RASASHALA 1. Sthana आतङ्क रमिता देशे धिमराज्य िनोरिे। उिा ििेश्वरोपेते सिृद्धे नगरे शुभे।।| कतमव्य साधनि् तत्र रसराजस्य धीिता। [R.R.S 611] STHANA BHAVANA ADIKARI EVAM KARMACHAR I KARYAVIB HAJANA
  • 6. 1. According to Rasendra Chudamani 3/1,2 • Sarvabadavivarjitha • Sarva aushadhi mahe deshe • Ramye • Kupasamanvithe 2. According to Rasatarangini 1/13 • Vimalo upavana pradeshe • Ramye • Jalayantra shobhete • Kamaniya gavaksh samyukta • Nikila aushadha varga mandala • Janabhada rahita sankulat • Rasa siddheshwara chitra bushithe 3. According to Ananda Kanda 2/22 • Asthika prani subage. • Su rakshithe dware naranga ,dadima,jambhira,nimba, tala,hintala, bakula,amla,patola,ashoka etc.
  • 7. BHAVANA NIRMANA • [Ref: R.R.S 6/12] 1. ATYANTA UPAVANE 2. CHATHURDWARA UPASHOBITE 3. SUVISTIRNA 4. SAMYAK VATAYANAPETE 5. DIVYA CHITRA VICHITRITAHA
  • 9. ADHIKARI EVAM KARMACHARI ADIKARI 1. RASAVAIDYA 2. DHATUVADA SADAKA[Minerologist] 3. RASAYANA SADAKA[pharmacologist] 4. BAHUBASHYAKARA[linguist] KARMCHARI 1. AUSHADA SANGRAHAKARTA [Drug collector] 2. RASAKARTA SAHAYAKA[Pharmacy assistant] 3. BALI SADAKA[Security guard] 4. PARICHARAKA[Attender]
  • 10. GUNAS OF RASA VAIDYA [Ref- R.R.S 6/3-4] 1. JNANAVAN 2. DAKSHA 3. RASASHASTRA VISHARADA 4. MANTRA SIDDHA 5. MAHAVEERA 6. NISCHALA 7. SHIVAVATSALA BAKTHA 8. SADHADEERA 9. DEVATA ACHARYA TATPARA 10.SARVA KUSHALO RASA KARMANI
  • 11. SISHYA GUNA YOGYA AYOGYA 1. Guru bhaktha 1. Nasthika 2. Satyavanta 2. Durachara 3. Sadhachari 3. Chumbaka 4. Drudavruta 4. Guruto apara 5. Niralasya 5. Vidya grahito michanti 6. Dharmagnya 6. chaurya 7. Sadha agnya paripalaka 7. Na Sidhayet manimatraaushdhikam 8. Dambha matsarya nirmuktha 8. Eha loka sukam paraloka cha 9. Kula acharya dakshita 10. Atyantha sadhaka 11. Shanta [Ref- R.R.S 6/5- 6]
  • 12. PARICHARAKA GUNA 1. SA UDYAMA 2. SISHYASTHE 3. KULINA 4. SWAMI BHAKTHA 5. SHUCHI 6. SHURA 7. BALISTHA
  • 13. KALINI STREE [Ref-R.R.S 6/33-37] • She represents the goddess parvati and attained Rutu chakra in krishna paksha • Characteristics of kalini stree 1. Kinchita keshya 2. Shyama padma lochana 3. Surupa 4. Taruni 5. Mrudhu bhasini 6. Ashwatha patra sadrusya yoni • Kalini stree abava- 1 karsha shuddha gandhaka with go ghrita for 3 saptaha .Then she will attain the qualities of kalini stree • Importance of kalini stree- success in Rasabandha and other Rasayana kriya
  • 14. RASAMANTAPA • Rasa Mantapa ia the unique place & platform which is constructed for placing and worshipping Rasa Linga. It should be constructed within the rasashala in the eastern direction • It should posses shat kona , asta dala kamala • Samatala • Atigupta ,suvistirna • Should possess large arches and gates • The upperpart of Rasamantapa ia attaches with dwaja and chatra • Decorated with pushpa and mala • There be ringing sounds of beri,kahala, shrunga, ghanta • In the centre Rasa Linga is placed , and other rasa dravyas are placed in systemaic order , worshiping of Rasa Linga is carried by chanting the Agora mantra and Rasankushi mantra
  • 15.
  • 16. RASALINGA • [Ref: R.R.S 6/17] • Swarna patra - 3 Niskha Suddha Parada- 9 Nishka Bhavana dravya -nimbu swarasa for 1 yama kala further subjected to swedhana in dolayantra with jambira rasa or kanji for 1 day Importance of Rasa Linga • Regular worshipping of rasalinga should be done by chanting Agora and Rasankushi mantra to attain prosperity and to get rid of paap mukti • Equvalient to worshipping one thousand crore shiva Linga & and siddhi in all rasa kriya
  • 17. INSTRUMENTS & EQUIPMENTS REQUIRED FOR RASASHALA • [Ref:R.R.S 7/6-13] 1. Kostiyantra-satvapatanakosti,bhumikosti,chalakosti,patalakosti etc 2. Water storage tanks and containers of different sizes 3. Bhastrikas- 2[blowing bellows] 4. Metallic pipes-2,bamboo pipes -2 5. Kunda[vessels]-prepared with gold,silver,iron,copper,bronze,stone,leather 6. Kandani[small pounders]&peshini of different varietes 7. Droni(water tubs) ,khalwa yantra ,perhani of different sizes 8. Sieves 9. Chalani,shalaka and kundali (circular stands) 10. Mrittika for preparation of mushas( sweta,krishna,valmiki mritika) 11. Tusha(husk) ,karpasa(cotton),pistaka (dough) 12. Raw material for preparation of medicine [herbal,mineral,animal origin] 13. shikitra(coal),upala,valuka 14. Varaka[bottle] –made up of kacha,mritrika 15. Different Patra of different kinds for heating boiling etc.
  • 18. GMP • Good Manufacturing Practices is a set of legal guidelines that have been regulated by W.H.O since 1975. It aims to ensure that drugs and other pharmaceutical products are safe and effective • History of GMP-The GMP was first introduced in NASA in rocket technology, named as zero defect. • In India, GMP was introduced in 1988 as an amendment to Drug and Cosmetic rule 1945. In India licenses for manufacture of ASU drugs are issued only which fulfill the GMP requirement • Definition- A good manufacturing practice (GMP) is one that conforms to the guidelines set by the regulatory agencies that control authorization and licensing for the production and sale of food, beverages and active pharmaceutical products.
  • 19. RECOMMENDATIONS OF GMP Factory premises: • Receiving & storing of raw material • Manufacturing process areas • Quality control section • Finished goods store • Office • Rejected goods/drugs store 1. Factory premises 2. Guidelines of GMP
  • 20. GUIDELINES ACCORDING TO GMP 1. Location and Surrounding 2. Building 3. Water supply and disposal of waste 4. Containers cleaning and stores 5. Raw material 6. Production 7. Packaging materials and finished goods stores 8. Working place 9. Clothing and Hygiene 10. Medical services 11. Equipment 12. Batch manufacturing records 13. Distribution records 14. Labeling 15. Records of market complaints 16. Quality control
  • 21. 1.LOCATION AND SURROUNDINGS • Away from open sewage, drain, public lavatory & factory , To avoid contamination • And to prevent from disagreeable or noxious odour or fumes or excessive dust or smoke. 2. BUILDING • Free from insects/rodents. • Adequate light, ventilation and space. • Floor and wall should not be moist. • According to provision of factory act • Should permit easy cleaning and disinfection , the interior surface should be smooth and free from cracks • proper drainage system in the processing area .the sanitary fitting and electrial fixtures should be proper & safe • There should be fire safety measures & emergency exits
  • 22. 3. WATER SUPPLY AND DISPOSAL OF WASTE • Pure and of potable quality • Adequate provision of water for washing the premises • Provision for waste disposal should be made properly to avoid microbial contamination. And high degree of hygiene in the manufacturing area 4. CONTAINERS CLEANING AND STORES • Containers such as bottles, vials and jars are properly washed, cleaned, and dried. • stored properly • Storage area should have proper ventilation &free from dampness • Different storage area should be maintained for Raw material, Packaging material and Finished product.
  • 23. 5. RAW MATERIALS • stored properly • Good quality raw material should be selected & protected from microbial contamination • stored under different categories like the Raw material of metallic origin, mineral origin, animal origin, Fresh herbs, Dry herbs and plant parts. • Each container used for raw material storage shall be properly identified by name of the material, source of supply and status of the of raw material such as „UNDER TEST‟ or „APPROVED‟ or „REJECTED‟ • All the raw materials shall be sampled and got tested by the laboratories approved by Govt. for authentication, morphological , Organoleptic evaluation, microscopy evaluation, chemical evaluation • 6. PRODUCTION • Only approved materials are used. • Samples are taken, as appropriate, during or after processing, transfer or filling for testing. • Packages of finished products bear permanent code marks, to ensure not only quality, but also safety and efficacy of complex products of biological origin, such as herbal medicines, it is essential that their production is clearly defined
  • 24. 7. PACKAGING MATERIALS AND FINISHED GOODS STORES • Packaging materials such as bottles, jars are stored properly. • All containers and closure should be adequately cleaned and dried before packing the product. • The finished goods from the production area after proper packing are stored in finished goods stores marked as“Quarantine” • After the quality control laboratory experts have checked the finished goods and then it is moved to “Approved Finished Goods Stock” area. Only approved goods are dispacted as per marketing requriements. 8. WORKING SPACE • Adequate space for orderly placements of equipments & material. • To minimize or to eliminate any risk of mix-up between different drugs, raw materials to prevent the cross contamination of one drug by another drug that is manufactured, stored or handled in the same premises should be prevented
  • 25. 9. CLOTHING AND HYGIENE • Free from contagious disease . • clothing for workers consistes of proper uniform suitable according to nature of work & climate • The uniform also include cloth or synthetic covering for hands, feet and head wherever neccesary • Adequate facilities for personal cleanliness such as clean towels, soap and scrubbing brushes are also provided • Seprate provision for lavatories used by men & women ,& located seprate from processing rooms. • seprate sections for keeping their personal belongings & for changing clothes • 10. MEDICAL SERVICE Manufacturer shall provide: • Adequate facilities of first aid • And during the time of employment & periodical medical examination to workers. • It is done with particular attention keeping all the safety measures to avoid the spreed of infections. • And Records should be properly maintained
  • 26. 11. EQUIPMENT • Suitable equipment depending on the size & nature of production either manually ,semi-automatically or fully automatic machinery are made available • Different machines for crushing, grinding, powdering, boiling, mashing ,filtering, labelling etc. • Properly installed and cleaned periodcally • Space should be maintained b/w two machines for easy movement of worker. • Dried immediately after cleaning to avoid growth of microorganisms 12. DISTRIBUTION RECORDS • Record date, manpower, machines and equipments should be maintained. • Records of sale and distribution of each batch of ASU medicine shall be maintained in order to facilitate prompt and complete recall of the batch, if necessary
  • 27. 13. BATCH MANUFACTURING RECORDS • The licence should be maintain for each batch of ASU drugs manufactured irrespective of type of the product • List of raw materials, quantities and various tests with record should be maintained. • Record of quality control to finish product should be maintained • Only after the manufactured drugs have been verified and accepted shall be allowed for sale. • Tests conducted during the various stages of manufacture like taste, colour, physical characteritics & chemical test is necessary as mentioned in the First Schedule of the Drugs and Cosmetic Act, 1940. 14. RECORD OF MARKET COMPLAINTS • Manfactures shall maintain a register to record of market complaints received regarding the products when sold • Reports of adverse reaction resulting from use of ASU drug shall also be maintained in seprate record by each manfacture • Once in six months the reports should be submitted to licensing authority. • The manufacturer shall investigate any of the adverse reaction if found , due to any defect in the product, and whether such reaction are already reported earlier or it is new observation.
  • 28. 14. LABELING The label on outer container should bear - • Name of the product. • Statements of identifications and net contents, • Address of the firm manufacturing unit • General information about the product regarding the ingredients, quantity of ingredient, reference of the product. • self life, date of manufacturing, & date of expiry • Any contraindication of particular product 16. QUALITY CONTROL • Each manufacture shall provide facility for quality control section in their premises or through government approved testing laboratory .The test shall be as per the ASU pharmacopeia standard • Quality control section shall verify all raw materials, quality of finished product. • Quality control should have separate expert.
  • 29. It should have fallowing facilities : 1. Should be 150 sq.feet 2. For identification drugs, reference books & samples should be maintained 3. To verify the finished products, samples of finished products of each batch will be kept for 3 year 4. Manufactures of ASU medicines shall provide their own specification & control referances in respect of such formulated drugs 5. The record of specific procedures such as “Bhavan”, “Mardana” & “puta” shall be maintained 6. The standards for identification, purity,and strength as given in respective pharmacopoeia of ASU system of medicines published by government of india shall be complied 7. All raw materials are monitored for fungal,bacterial contamination with a view to minimise such contamination 8. [a] one person with degree qualification in ASU as per schedule 2 of MEDICINE CENTRAL COUNCIL ACT 1970
  • 30. MINIMUM MANUFACTURING PREMISES REQUIRED FOR THE MANUFACTURE OF AYURVEDIC MEDICINES CATEGORY OF MEDICINE MINIMUM MANUFACTURING SPACE REQURIED 1. Arka, pills/vati/gutika, ointment , capsule,Anjana/Pisti ,Tila,ghrita 100 Sq.feet 2. Kupi pakva/Ksara/Parpati/Lavana Bhasma/satva/sindura/karpu/ avaleha/khand/modaka/panak/syrup/ kwath 150 Sq. feet 3. churna/nasya manjan/lepa/asava/arista/ kwathchurna 200 Sq.feet
  • 31. COMPARISIONS BETWEEN RASAMANTAP AND GMP • As Ayurveda origined from the vedic period they belived more on divinity so worshipping of Rasalinga has been given prime importance , where as in GMP they is no such referance about worshipping god • Rasashala ia mainly built on vastu shastra , but according to GMP premises are built according the guildlines and convinience • In Rasashala placement of instrunment & processes pertaining to parada & other Rasa dravya are done in 8 direction keeping view of asta dikh palakas where as in GMP they concentrated only on the infracuture • In Rasashala , particular characteristics for appointment of Rasavaidya, Sishya,Parichara and kalini stree is mentioned where as in GMP appointments are done only on qualifications of individual
  • 32. RESEARCH ARTICLE conclusion • GMP is an essential and significant step taken by the Government in improving the quality and standard of ASU drugs being manufactured in about 9000 licensed ASU pharmacies in our country. In the similar way our ancient Acharyas were much more concerned about minutest parts of the bhesajagara/rasasala. In almost every classical text of Rasashastra usually a separate chapter is devoted in describing building of a production unit. In such description right from selection of the place, to accurate and well thought of directions regarding various departments section and staff, financial requirements and security are also given. It must be remembered that all these texts date back to a period between 1st to 16th centuries. It therefore need not be stated that the description are as per need of the period,
  • 33. DISCUSSION • Acharyas were very much concerned about minutest parts of the rasasala. They concentrated not only on the construction of the manufacturing unit but also on the selection of place for construction, interior plans and arrangement etc. • The building, water supply, disposal of waste, containers cleaning and stores, etc are similar to those mentioned in Ayurveda. • For working Space, different sections are mentioned for agni karma, sastra karma, kshalana karma etc which are related to vastu shastra. • The different equipments mentioned in samhitas for Rasashala are according to the materials avaiable, quantity of medicine manufactured and the type of medicine prepared during those days. • With times, advancement in science, growing demand of medicines these instruments have been replaced by more sophisticated machinaries which can meet the demands of the society in a short span of time. • Acharyas were very well aware of the quality and hence mentioned about dravya sangrahana and dravya samrakshana vidhi which assured good quality of the medicines.
  • 34. CONCLUSION • In Rasashala, medicines are prepared according to classics and in traditional way • In GMP certified pharmacy, medicines are prepared in bulk. • Concepts of GMP were followed from the vedic period and the references can be seen in ayurvedic textes which have given elaborate description about the Rasashala and also about the production of medicine • To meet the worldwide demand for herbo-mineral drugs ,it is essential to maintain GMP • Implementing GMP for herbo-mineral drugs, as per the recent amendment of the DRUGS AND COSMECTIC ACT of the government of india with a buffer period of two years,is a great challenge for ayurvedic drugs. • Recently Govt. of India has notified GMP for ISM .this is also aimed to ensure production of good quality medicines for the consumer in the domestic & international market.