SlideShare a Scribd company logo
DR. MANISHA GOYAL
           Assistant professor
      RASA SHASTRA DEPT.
RAJASTHAN AYURVEDA UNIVERSITY
        JODHPUR(RAJ.)
• Shedule “T” Of Drug And Cosmatic Rule 1945.(Rule
  157)



• "GMP" - A set of principles and procedures which,
  when followed by manufacturers for therapeutic
  goods, helps ensure that the products
  manufactured will have the required quality.
AYURVEDA
• Rasa shala v/s GMP
• Atank rahite deshe--------samyakvatayanopeta
  divyechitravichitrta l
                                  ( R.R.S.6/11-16)
  Rasa shala prakurvita-----------nana
  upkaranupeta prakaren sushobhita l
                                    (R.R.S. 7/1-8)
RASA SHALA
                Vedha
                  N
 Vayav                             ishan



Prakshalan                Ras Bhairav
w                                       E



Nair                             Agney
                  S
              Pashan
objectives
• Raw materials used in the manufacture of
  drugs are -
- authentic,
- prescribed quality
- free from contamination
• the manufacturing process is as has been
  prescribed to maintain the standards
• adequate quality control measures are
  adopted
• the manufactured drug which is released for
  sale is of acceptable quality
• the prescribed process of manufacture of
  drugs should be documented as a manual and
  kept for reference and inspection.
1st                      2nd   LIST OF
      Factory Premises         MACHINERY,
                               EQUIPMENT



      General                  MANUFACTURING
      Requirements             PREMISES
Factory Premises
•    receiving and storing raw material;
•   manufacturing process areas;
•   Quality control section;
•   finished goods store;
•    office;
•   rejected goods/drugs store.
General requirements
•   Location and surroundings
•   Buildings:
•   Water Supply:
•   Disposal of Waste:
•   Container’s Cleaning:
•   Stores:
•   Working space:

                        9
General requirements
• Healthy Clothing, Sanitation and Hygiene of
  Workers:
• Medical Services:
• Equipment:
• Batch Manufacturing Records:
• Distribution Records:
• Record of Market Complaints:
• Quality Control:

                       10
Location and surroundings

The factory building for manufacture of ASU
medicines shall be-
so situated and shall have such construction as
to avoid contamination from open sewerage,
drain, public lavatory for any factory which
produces disagreeable or obnoxious odour or
fumes or excessive soot, dust and smoke.
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.
-   working space to allow orderly and logical placement of equipment and materials
    to avoid the risk of cross contamination by other drugs or substances.

-   It is Designed, constructed and maintained to prevent entry of insects and rodents.

-    Interior surface (walls, floors and ceilings) shall be smooth and free from cracks
    and permit easy cleaning and disinfection

-   The sanitary fittings and electrical fixtures in the manufacturing area shall be
    proper and safe.

-   Furnace/Bhatti section could be covered with tin roof and proper ventilation, but
    sufficient care should be taken to prevent flies and dust.
    There should be fire safety measures and proper exits should be there.

-   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.
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
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.
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.
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.
Stores

                         Raw material store



Packing material store




                             Finished goods 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 flavours
   8. Plant concentrates/ extracts and exudates/resins.
• Each container used for raw material storage shall be properly identified with the
  label
  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 labels shall further indicate the identity of the particular supply in the form of
  Batch No. or Lot No. and the date of receipt of the consignment.
• All the raw materials shall be sampled and got tested either by the in-house
  Ayurvedic, Siddha and Unani experts (Quality control technical person) or by the
  laboratories approved by the Government and shall be used only on approval after
  verifying.
• The rejected raw material should be removed from other raw material store and
  should be kept in separate room. Procedure of ‘First in first out’ should be adopted
  for raw materials wherever necessary.
• Records of the receipt, testing and approval or rejection and use of raw material
  shall be maintained
(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.
(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
“Quarantine”. After the quality control laboratory and the
experts have checked the correctness of finished goods
with reference to its packing/labeling as well as finished
product quality as prescribed, then it will be moved to
“Approved Finished Goods Stock” area. Only approved
finished goods shall be dispatched as per marketing
requirements. Distribution records shall be maintained as
required.
Working space
   The manufacturing area shall provide adequate
  space-
• 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.
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.
• 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.
Machinery and Equipments
• It is 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. List of equipments and machinery recommended is indicated in
  Part II A.
• Proper Standard Operational Procedures (SOPs) for cleaning, maintaining
  and performance of every machine should be laid down.
Batch Manufacturing Records
• Manufacturing records are required to provide an account of the list of raw
  materials and their quantities obtained from the store, tests conducted
  during the various stages of manufacture like taste, colour, physical
  characteristics and chemical tests as may be necessary or indicated in the
  approved books of Ayurveda, Siddha and Unani mentioned in the First
  Schedule of the Drugs and Cosmetics Act, 1940 (23 of 1940.
• Details of transfer of manufactured drug to the finished products store
  including dates and quantity of drugs transferred along with record of
  testing of the finished product, if any, and packaging, records shall be
  maintained. Only after the manufactured drugs have been verified and
  accepted quality shall be allowed to be cleared for sale.
• It should be essential to maintain the record of date, manpower, machine
  and equipments used and
• to keep in process record of various shodhana, Bhavana, burning and fire
  and specific grindings in terms of internal use.
Distribution Records.
• Records of sale and distribution of each batch of
  Ayurveda, Siddha and Unai Drugs shall be maintained in
  order to facilitate prompt and complete recall of the
  batch, if necessary.

• The duration of record keeping should be the date of
  expiry of the batch. Certain category of Ayurvedic,
  siddha and Unani medicines like Bhasma, Rasa, Kupi-
  pakva, Parpati, Sindura, Karpu/uppu/puram, kushta,
  Asava-arishta etc. do not have expiry date in contrast
  their efficiency increases with the passage of time.
  Hence, records need be maintained upto five years of the
  exhausting of stock.
Record of Market Complaints
     Manufacturers shall maintain a register to record
•   all reports of market complaints received regarding the products
    sold in the market.
•   manufacturer shall enter all data received on such market
    complaints, investigations carried out by the manufacturers
    regarding the complaint as well as any corrective action initiated
    to prevent recurrence of such market complaints shall also be
    recorded.
•    Once in a period of six months the manufacturer shall submit the
    record of such complaints to the licensing authority. The Register
    shall also be available for inspection during any inspection of the
    premises.
•    Records of any adverse reaction resulting from the use of
    Ayurvedic, Siddha and Unani drugs shall also be maintained in a
    separate register by each manufacturer
quality control section
quality control
1) There should be 150 sq. feet area for quality control section.

2) For identification of raw drugs, reference books and reference samples should be
  maintained.
3) Manufacturing record should be maintained for the various processes.

4) To verify the finished products, controlled samples of finished products of each
batch will be kept for 3 years.

5) To supervise and monitor adequacy of conditions under which raw materials,
semifinished 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
    pharmacopoeias of Ayurveda, Siddha and Unani 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.

11) Quality control section will have a minimum of:
     One person with Ayurveda /Siddha/ Unani qualification recognized under
   Schedule II of Indian Medicine Central Council Act, 1970 (84 of 1970). Two other
   persons one each with Bachelor qualification in Botony/ Chemistry/ Pharmacy
   could be on part time or contractual basis.
PART 2nd




Total area for the manufacturung
  premices:-
 1200 Square feet covered area
  with separate cabins partitions
  for each activity.
• 100 sq.feet area
        Anjana/Pisti
Pills,Kajal,CapsulesOintment
                                • Kharel/End runner/BallMili/Sieves Shifter
 Avalesh,Sura,Ark,Tail/Ghrit
                                  Capsule filling machine and chemical
                                  balance etc.equipments


      Churna / Nasya            • 200sq.feet area
Manjan/Lepa/Asava / Arishta     • Grinder / disintegrator /Pulverisar /
 a separate area for Bhatti,      Powder mixer/Fermentation tanks
 furnace, boilers, puta, etc.     containers and distillation plant


                                • 150sq.feet area
   Kupi pakava / Ksara /        • Bhatti,Karahi/Patila Flask,copper Rod,
  Parpati / Lavana Bhasma         Earthern
    Satva/Panak / Syrup           container,GajPutBhatti,Mufflefurnace
                                  EndRunner,ExhaustFan
THANK YOU

More Related Content

What's hot

Historical backround of rasashastra
Historical backround of rasashastraHistorical backround of rasashastra
Historical backround of rasashastra
Ayushman Bhava Ayurveda and keraliya Panchakarma Clinic
 
1 introduction and history of Rasashastra. Dr.Mahantesh Rudrapuri
1  introduction and  history of Rasashastra. Dr.Mahantesh Rudrapuri1  introduction and  history of Rasashastra. Dr.Mahantesh Rudrapuri
1 introduction and history of Rasashastra. Dr.Mahantesh Rudrapuri
Shri Shivayogeeshwar Rural Ayurvedic Medical college, INCHAL,
 
SAVEERYATA AVADHI ( SHELF LIFE PERIOD)
SAVEERYATA AVADHI ( SHELF LIFE PERIOD)SAVEERYATA AVADHI ( SHELF LIFE PERIOD)
SAVEERYATA AVADHI ( SHELF LIFE PERIOD)
Anjana Narayanan
 
Panchavidha kashay kalpana
Panchavidha kashay kalpanaPanchavidha kashay kalpana
Panchavidha kashay kalpana
DrNitesh Mahant
 
Ayurvedic pharmacopoeia of india
Ayurvedic pharmacopoeia of indiaAyurvedic pharmacopoeia of india
Ayurvedic pharmacopoeia of india
Priyanka Sanagala
 
Avaleha kalpana-Dr.MEENU SWAMINATH
Avaleha kalpana-Dr.MEENU SWAMINATHAvaleha kalpana-Dr.MEENU SWAMINATH
Avaleha kalpana-Dr.MEENU SWAMINATH
Meenu Swaminath
 
Parada
ParadaParada
Lepa kalpana
Lepa kalpanaLepa kalpana
Lepa kalpana
Anjana Narayanan
 
The Concept of Pakshachedhana in Ayurveda Rasasastra
The Concept of Pakshachedhana in Ayurveda RasasastraThe Concept of Pakshachedhana in Ayurveda Rasasastra
The Concept of Pakshachedhana in Ayurveda Rasasastra
Ebinuday
 
RASESWARA DARSANA
RASESWARA DARSANA  RASESWARA DARSANA
RASESWARA DARSANA
Anjana Narayanan
 
Pottali Kalpas
Pottali KalpasPottali Kalpas
Pottali Kalpas
Shobhitha Madhur
 
Profound knowledge of applied aspect of agrya aushadha
Profound knowledge of applied aspect of agrya aushadhaProfound knowledge of applied aspect of agrya aushadha
Profound knowledge of applied aspect of agrya aushadha
Vaidya Ganga
 
Pharmacovigilance for ASU Drugs
Pharmacovigilance for ASU DrugsPharmacovigilance for ASU Drugs
Pharmacovigilance for ASU Drugs
Dr.Prajeesh Nath E N
 
Karma
KarmaKarma
Karma
MrunalAkre
 
Paribhasha 2
Paribhasha 2Paribhasha 2
Paribhasha 2
somil1d11
 
Sandhana kalpana by Dr.shrilata
Sandhana kalpana by Dr.shrilataSandhana kalpana by Dr.shrilata
Sandhana kalpana by Dr.shrilata
Shrilata AP
 
concept of pratinidhi dravya.pptx
concept of pratinidhi dravya.pptxconcept of pratinidhi dravya.pptx
concept of pratinidhi dravya.pptx
SapnaMahant
 
churna kalpana.pptx
churna kalpana.pptxchurna kalpana.pptx
churna kalpana.pptx
DIVYASINGH992260
 
Chronological Development of Rasa Shastra
Chronological Development of Rasa ShastraChronological Development of Rasa Shastra
Chronological Development of Rasa Shastra
ijtsrd
 
sneha kalpana
 sneha kalpana sneha kalpana
sneha kalpana
Seetaram Kishore
 

What's hot (20)

Historical backround of rasashastra
Historical backround of rasashastraHistorical backround of rasashastra
Historical backround of rasashastra
 
1 introduction and history of Rasashastra. Dr.Mahantesh Rudrapuri
1  introduction and  history of Rasashastra. Dr.Mahantesh Rudrapuri1  introduction and  history of Rasashastra. Dr.Mahantesh Rudrapuri
1 introduction and history of Rasashastra. Dr.Mahantesh Rudrapuri
 
SAVEERYATA AVADHI ( SHELF LIFE PERIOD)
SAVEERYATA AVADHI ( SHELF LIFE PERIOD)SAVEERYATA AVADHI ( SHELF LIFE PERIOD)
SAVEERYATA AVADHI ( SHELF LIFE PERIOD)
 
Panchavidha kashay kalpana
Panchavidha kashay kalpanaPanchavidha kashay kalpana
Panchavidha kashay kalpana
 
Ayurvedic pharmacopoeia of india
Ayurvedic pharmacopoeia of indiaAyurvedic pharmacopoeia of india
Ayurvedic pharmacopoeia of india
 
Avaleha kalpana-Dr.MEENU SWAMINATH
Avaleha kalpana-Dr.MEENU SWAMINATHAvaleha kalpana-Dr.MEENU SWAMINATH
Avaleha kalpana-Dr.MEENU SWAMINATH
 
Parada
ParadaParada
Parada
 
Lepa kalpana
Lepa kalpanaLepa kalpana
Lepa kalpana
 
The Concept of Pakshachedhana in Ayurveda Rasasastra
The Concept of Pakshachedhana in Ayurveda RasasastraThe Concept of Pakshachedhana in Ayurveda Rasasastra
The Concept of Pakshachedhana in Ayurveda Rasasastra
 
RASESWARA DARSANA
RASESWARA DARSANA  RASESWARA DARSANA
RASESWARA DARSANA
 
Pottali Kalpas
Pottali KalpasPottali Kalpas
Pottali Kalpas
 
Profound knowledge of applied aspect of agrya aushadha
Profound knowledge of applied aspect of agrya aushadhaProfound knowledge of applied aspect of agrya aushadha
Profound knowledge of applied aspect of agrya aushadha
 
Pharmacovigilance for ASU Drugs
Pharmacovigilance for ASU DrugsPharmacovigilance for ASU Drugs
Pharmacovigilance for ASU Drugs
 
Karma
KarmaKarma
Karma
 
Paribhasha 2
Paribhasha 2Paribhasha 2
Paribhasha 2
 
Sandhana kalpana by Dr.shrilata
Sandhana kalpana by Dr.shrilataSandhana kalpana by Dr.shrilata
Sandhana kalpana by Dr.shrilata
 
concept of pratinidhi dravya.pptx
concept of pratinidhi dravya.pptxconcept of pratinidhi dravya.pptx
concept of pratinidhi dravya.pptx
 
churna kalpana.pptx
churna kalpana.pptxchurna kalpana.pptx
churna kalpana.pptx
 
Chronological Development of Rasa Shastra
Chronological Development of Rasa ShastraChronological Development of Rasa Shastra
Chronological Development of Rasa Shastra
 
sneha kalpana
 sneha kalpana sneha kalpana
sneha kalpana
 

Viewers also liked

DENTIST act OF india
DENTIST act OF indiaDENTIST act OF india
DENTIST act OF india
Ajins Thudhupillyl
 
Government Order for Morden Practice
Government Order  for Morden PracticeGovernment Order  for Morden Practice
Government Order for Morden Practice
Dr.Sabari Nathan
 
Dentist Act of India, DCI & IDA
Dentist Act of India, DCI & IDADentist Act of India, DCI & IDA
Dentist Act of India, DCI & IDA
Jippy Jack
 
Central registration with CCIM
Central registration with CCIMCentral registration with CCIM
Central registration with CCIM
Dr.Surendra Chaudhary
 
Schedule t
Schedule tSchedule t
Laws Applicable For I S M Dr`S
Laws  Applicable For  I S M  Dr`SLaws  Applicable For  I S M  Dr`S
Laws Applicable For I S M Dr`S
Dr.Sabari Nathan
 

Viewers also liked (6)

DENTIST act OF india
DENTIST act OF indiaDENTIST act OF india
DENTIST act OF india
 
Government Order for Morden Practice
Government Order  for Morden PracticeGovernment Order  for Morden Practice
Government Order for Morden Practice
 
Dentist Act of India, DCI & IDA
Dentist Act of India, DCI & IDADentist Act of India, DCI & IDA
Dentist Act of India, DCI & IDA
 
Central registration with CCIM
Central registration with CCIMCentral registration with CCIM
Central registration with CCIM
 
Schedule t
Schedule tSchedule t
Schedule t
 
Laws Applicable For I S M Dr`S
Laws  Applicable For  I S M  Dr`SLaws  Applicable For  I S M  Dr`S
Laws Applicable For I S M Dr`S
 

Similar to Gmp ayurveda

Good Manufacturing P ractice of Indian system of medicine (GMP).ppt by Dr. U...
Good Manufacturing P ractice of Indian system of medicine (GMP).ppt  by Dr. U...Good Manufacturing P ractice of Indian system of medicine (GMP).ppt  by Dr. U...
Good Manufacturing P ractice of Indian system of medicine (GMP).ppt by Dr. U...
SrinivasUmmanabad
 
PHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROL
PHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROLPHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROL
PHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROL
Arunpandiyan59
 
C gmp
C gmpC gmp
C gmp
SACHIN C P
 
GMP of ASU Drugs
GMP of ASU DrugsGMP of ASU Drugs
GMP of ASU Drugs
Akhtar Ali
 
GMP for phytomedicine
GMP for phytomedicineGMP for phytomedicine
GMP for phytomedicine
zahera khan
 
Good manufacturing practice
Good manufacturing practiceGood manufacturing practice
Scedule T.pptx
Scedule T.pptxScedule T.pptx
Scedule T.pptx
SonaliGadge4
 
SCHEDULE T GMP INDIAN SYSTEM OF MEDICINE
SCHEDULE T GMP INDIAN SYSTEM OF MEDICINE SCHEDULE T GMP INDIAN SYSTEM OF MEDICINE
SCHEDULE T GMP INDIAN SYSTEM OF MEDICINE
Pranjal Saxena
 
Ketindan 25 april 2013
Ketindan 25 april 2013Ketindan 25 april 2013
Ketindan 25 april 2013
Bbpp Ketindan
 
C gmp
C gmpC gmp
GMP presentation.pptx
GMP presentation.pptxGMP presentation.pptx
GMP presentation.pptx
garima mailk
 
pratik ghive cGMP According to schedule M
pratik ghive cGMP According to schedule Mpratik ghive cGMP According to schedule M
pratik ghive cGMP According to schedule M
pratikghive82
 
Gmp qa and doccumentation by kailash vilegave
Gmp qa and doccumentation by kailash vilegaveGmp qa and doccumentation by kailash vilegave
Gmp qa and doccumentation by kailash vilegave
Kailash Vilegave
 
current good manufacturing practices as per who
current good manufacturing practices as per whocurrent good manufacturing practices as per who
current good manufacturing practices as per who
Dilipkumar Velde
 
Good manufacturing
Good manufacturingGood manufacturing
Good manufacturing
Dr. Vir Vikram
 
SCHEDULE-T (1).pptx
SCHEDULE-T (1).pptxSCHEDULE-T (1).pptx
SCHEDULE-T (1).pptx
SanaSultana37
 
DRUGS AND COSMETICS ACT 1940 AND RULES THEIR UNDER 1945 SCHEDULE M.
DRUGS AND COSMETICS ACT 1940 AND RULES THEIR UNDER 1945 SCHEDULE M.DRUGS AND COSMETICS ACT 1940 AND RULES THEIR UNDER 1945 SCHEDULE M.
DRUGS AND COSMETICS ACT 1940 AND RULES THEIR UNDER 1945 SCHEDULE M.
Tushar Morankar
 
GMP for Nutraceuticals .pdf
GMP for Nutraceuticals  .pdfGMP for Nutraceuticals  .pdf
GMP for Nutraceuticals .pdf
BhavikaAPatel
 
Premises - Part of Good Manufacturing Practices
Premises - Part of Good Manufacturing PracticesPremises - Part of Good Manufacturing Practices
Premises - Part of Good Manufacturing Practices
Teny Thomas
 
GOOD MANUFACTURING PRACTICES AND QUALITY ASSURANCE.pdf
GOOD MANUFACTURING PRACTICES AND QUALITY ASSURANCE.pdfGOOD MANUFACTURING PRACTICES AND QUALITY ASSURANCE.pdf
GOOD MANUFACTURING PRACTICES AND QUALITY ASSURANCE.pdf
poornima335163
 

Similar to Gmp ayurveda (20)

Good Manufacturing P ractice of Indian system of medicine (GMP).ppt by Dr. U...
Good Manufacturing P ractice of Indian system of medicine (GMP).ppt  by Dr. U...Good Manufacturing P ractice of Indian system of medicine (GMP).ppt  by Dr. U...
Good Manufacturing P ractice of Indian system of medicine (GMP).ppt by Dr. U...
 
PHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROL
PHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROLPHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROL
PHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROL
 
C gmp
C gmpC gmp
C gmp
 
GMP of ASU Drugs
GMP of ASU DrugsGMP of ASU Drugs
GMP of ASU Drugs
 
GMP for phytomedicine
GMP for phytomedicineGMP for phytomedicine
GMP for phytomedicine
 
Good manufacturing practice
Good manufacturing practiceGood manufacturing practice
Good manufacturing practice
 
Scedule T.pptx
Scedule T.pptxScedule T.pptx
Scedule T.pptx
 
SCHEDULE T GMP INDIAN SYSTEM OF MEDICINE
SCHEDULE T GMP INDIAN SYSTEM OF MEDICINE SCHEDULE T GMP INDIAN SYSTEM OF MEDICINE
SCHEDULE T GMP INDIAN SYSTEM OF MEDICINE
 
Ketindan 25 april 2013
Ketindan 25 april 2013Ketindan 25 april 2013
Ketindan 25 april 2013
 
C gmp
C gmpC gmp
C gmp
 
GMP presentation.pptx
GMP presentation.pptxGMP presentation.pptx
GMP presentation.pptx
 
pratik ghive cGMP According to schedule M
pratik ghive cGMP According to schedule Mpratik ghive cGMP According to schedule M
pratik ghive cGMP According to schedule M
 
Gmp qa and doccumentation by kailash vilegave
Gmp qa and doccumentation by kailash vilegaveGmp qa and doccumentation by kailash vilegave
Gmp qa and doccumentation by kailash vilegave
 
current good manufacturing practices as per who
current good manufacturing practices as per whocurrent good manufacturing practices as per who
current good manufacturing practices as per who
 
Good manufacturing
Good manufacturingGood manufacturing
Good manufacturing
 
SCHEDULE-T (1).pptx
SCHEDULE-T (1).pptxSCHEDULE-T (1).pptx
SCHEDULE-T (1).pptx
 
DRUGS AND COSMETICS ACT 1940 AND RULES THEIR UNDER 1945 SCHEDULE M.
DRUGS AND COSMETICS ACT 1940 AND RULES THEIR UNDER 1945 SCHEDULE M.DRUGS AND COSMETICS ACT 1940 AND RULES THEIR UNDER 1945 SCHEDULE M.
DRUGS AND COSMETICS ACT 1940 AND RULES THEIR UNDER 1945 SCHEDULE M.
 
GMP for Nutraceuticals .pdf
GMP for Nutraceuticals  .pdfGMP for Nutraceuticals  .pdf
GMP for Nutraceuticals .pdf
 
Premises - Part of Good Manufacturing Practices
Premises - Part of Good Manufacturing PracticesPremises - Part of Good Manufacturing Practices
Premises - Part of Good Manufacturing Practices
 
GOOD MANUFACTURING PRACTICES AND QUALITY ASSURANCE.pdf
GOOD MANUFACTURING PRACTICES AND QUALITY ASSURANCE.pdfGOOD MANUFACTURING PRACTICES AND QUALITY ASSURANCE.pdf
GOOD MANUFACTURING PRACTICES AND QUALITY ASSURANCE.pdf
 

Recently uploaded

Lecture_Notes_Unit4_Chapter_8_9_10_RDBMS for the students affiliated by alaga...
Lecture_Notes_Unit4_Chapter_8_9_10_RDBMS for the students affiliated by alaga...Lecture_Notes_Unit4_Chapter_8_9_10_RDBMS for the students affiliated by alaga...
Lecture_Notes_Unit4_Chapter_8_9_10_RDBMS for the students affiliated by alaga...
Murugan Solaiyappan
 
How to Create & Publish a Blog in Odoo 17 Website
How to Create & Publish a Blog in Odoo 17 WebsiteHow to Create & Publish a Blog in Odoo 17 Website
How to Create & Publish a Blog in Odoo 17 Website
Celine George
 
Odoo 17 Social Marketing - Lead Generation On Facebook
Odoo 17 Social Marketing - Lead Generation On FacebookOdoo 17 Social Marketing - Lead Generation On Facebook
Odoo 17 Social Marketing - Lead Generation On Facebook
Celine George
 
Power of Ignored Skills: Change the Way You Think and Decide by Manoj Tripathi
Power of Ignored Skills: Change the Way You Think and Decide by Manoj TripathiPower of Ignored Skills: Change the Way You Think and Decide by Manoj Tripathi
Power of Ignored Skills: Change the Way You Think and Decide by Manoj Tripathi
Pankaj523992
 
View Inheritance in Odoo 17 - Odoo 17 Slides
View Inheritance in Odoo 17 - Odoo 17  SlidesView Inheritance in Odoo 17 - Odoo 17  Slides
View Inheritance in Odoo 17 - Odoo 17 Slides
Celine George
 
(T.L.E.) Agriculture: Essentials of Gardening
(T.L.E.) Agriculture: Essentials of Gardening(T.L.E.) Agriculture: Essentials of Gardening
(T.L.E.) Agriculture: Essentials of Gardening
MJDuyan
 
How to Manage Line Discount in Odoo 17 POS
How to Manage Line Discount in Odoo 17 POSHow to Manage Line Discount in Odoo 17 POS
How to Manage Line Discount in Odoo 17 POS
Celine George
 
Debts of Gratitude - Esselde and Informal Letter.pptx
Debts of Gratitude - Esselde and Informal Letter.pptxDebts of Gratitude - Esselde and Informal Letter.pptx
Debts of Gratitude - Esselde and Informal Letter.pptx
AncyTEnglish
 
How to Manage Access Rights & User Types in Odoo 17
How to Manage Access Rights & User Types in Odoo 17How to Manage Access Rights & User Types in Odoo 17
How to Manage Access Rights & User Types in Odoo 17
Celine George
 
Benchmarking Sustainability: Neurosciences and AI Tech Research in Macau - Ke...
Benchmarking Sustainability: Neurosciences and AI Tech Research in Macau - Ke...Benchmarking Sustainability: Neurosciences and AI Tech Research in Macau - Ke...
Benchmarking Sustainability: Neurosciences and AI Tech Research in Macau - Ke...
Alvaro Barbosa
 
Bài tập bộ trợ anh 7 I learn smart world kì 1 năm học 2022 2023 unit 1.doc
Bài tập bộ trợ anh 7 I learn smart world kì 1 năm học 2022 2023 unit 1.docBài tập bộ trợ anh 7 I learn smart world kì 1 năm học 2022 2023 unit 1.doc
Bài tập bộ trợ anh 7 I learn smart world kì 1 năm học 2022 2023 unit 1.doc
PhngThLmHnh
 
Individual Performance Commitment Review Form-Developmental Plan.docx
Individual Performance Commitment Review Form-Developmental Plan.docxIndividual Performance Commitment Review Form-Developmental Plan.docx
Individual Performance Commitment Review Form-Developmental Plan.docx
monicaaringo1
 
formative Evaluation By Dr.Kshirsagar R.V
formative Evaluation By Dr.Kshirsagar R.Vformative Evaluation By Dr.Kshirsagar R.V
formative Evaluation By Dr.Kshirsagar R.V
DrRavindrakshirsagar1
 
SEQUNCES Lecture_Notes_Unit4_chapter11_sequence
SEQUNCES  Lecture_Notes_Unit4_chapter11_sequenceSEQUNCES  Lecture_Notes_Unit4_chapter11_sequence
SEQUNCES Lecture_Notes_Unit4_chapter11_sequence
Murugan Solaiyappan
 
CTD Punjab Police Past Papers MCQs PPSC PDF
CTD Punjab Police Past Papers MCQs PPSC PDFCTD Punjab Police Past Papers MCQs PPSC PDF
CTD Punjab Police Past Papers MCQs PPSC PDF
hammadmughal76316
 
BRIGADA ESKWELA OPENING PROGRAM KICK OFF.pptx
BRIGADA ESKWELA OPENING PROGRAM KICK OFF.pptxBRIGADA ESKWELA OPENING PROGRAM KICK OFF.pptx
BRIGADA ESKWELA OPENING PROGRAM KICK OFF.pptx
kambal1234567890
 
How to Manage Early Receipt Printing in Odoo 17 POS
How to Manage Early Receipt Printing in Odoo 17 POSHow to Manage Early Receipt Printing in Odoo 17 POS
How to Manage Early Receipt Printing in Odoo 17 POS
Celine George
 
What is Packaging of Products in Odoo 17
What is Packaging of Products in Odoo 17What is Packaging of Products in Odoo 17
What is Packaging of Products in Odoo 17
Celine George
 
How to Add a Filter in the Odoo 17 - Odoo 17 Slides
How to Add a Filter in the Odoo 17 - Odoo 17 SlidesHow to Add a Filter in the Odoo 17 - Odoo 17 Slides
How to Add a Filter in the Odoo 17 - Odoo 17 Slides
Celine George
 
Imagination in Computer Science Research
Imagination in Computer Science ResearchImagination in Computer Science Research
Imagination in Computer Science Research
Abhik Roychoudhury
 

Recently uploaded (20)

Lecture_Notes_Unit4_Chapter_8_9_10_RDBMS for the students affiliated by alaga...
Lecture_Notes_Unit4_Chapter_8_9_10_RDBMS for the students affiliated by alaga...Lecture_Notes_Unit4_Chapter_8_9_10_RDBMS for the students affiliated by alaga...
Lecture_Notes_Unit4_Chapter_8_9_10_RDBMS for the students affiliated by alaga...
 
How to Create & Publish a Blog in Odoo 17 Website
How to Create & Publish a Blog in Odoo 17 WebsiteHow to Create & Publish a Blog in Odoo 17 Website
How to Create & Publish a Blog in Odoo 17 Website
 
Odoo 17 Social Marketing - Lead Generation On Facebook
Odoo 17 Social Marketing - Lead Generation On FacebookOdoo 17 Social Marketing - Lead Generation On Facebook
Odoo 17 Social Marketing - Lead Generation On Facebook
 
Power of Ignored Skills: Change the Way You Think and Decide by Manoj Tripathi
Power of Ignored Skills: Change the Way You Think and Decide by Manoj TripathiPower of Ignored Skills: Change the Way You Think and Decide by Manoj Tripathi
Power of Ignored Skills: Change the Way You Think and Decide by Manoj Tripathi
 
View Inheritance in Odoo 17 - Odoo 17 Slides
View Inheritance in Odoo 17 - Odoo 17  SlidesView Inheritance in Odoo 17 - Odoo 17  Slides
View Inheritance in Odoo 17 - Odoo 17 Slides
 
(T.L.E.) Agriculture: Essentials of Gardening
(T.L.E.) Agriculture: Essentials of Gardening(T.L.E.) Agriculture: Essentials of Gardening
(T.L.E.) Agriculture: Essentials of Gardening
 
How to Manage Line Discount in Odoo 17 POS
How to Manage Line Discount in Odoo 17 POSHow to Manage Line Discount in Odoo 17 POS
How to Manage Line Discount in Odoo 17 POS
 
Debts of Gratitude - Esselde and Informal Letter.pptx
Debts of Gratitude - Esselde and Informal Letter.pptxDebts of Gratitude - Esselde and Informal Letter.pptx
Debts of Gratitude - Esselde and Informal Letter.pptx
 
How to Manage Access Rights & User Types in Odoo 17
How to Manage Access Rights & User Types in Odoo 17How to Manage Access Rights & User Types in Odoo 17
How to Manage Access Rights & User Types in Odoo 17
 
Benchmarking Sustainability: Neurosciences and AI Tech Research in Macau - Ke...
Benchmarking Sustainability: Neurosciences and AI Tech Research in Macau - Ke...Benchmarking Sustainability: Neurosciences and AI Tech Research in Macau - Ke...
Benchmarking Sustainability: Neurosciences and AI Tech Research in Macau - Ke...
 
Bài tập bộ trợ anh 7 I learn smart world kì 1 năm học 2022 2023 unit 1.doc
Bài tập bộ trợ anh 7 I learn smart world kì 1 năm học 2022 2023 unit 1.docBài tập bộ trợ anh 7 I learn smart world kì 1 năm học 2022 2023 unit 1.doc
Bài tập bộ trợ anh 7 I learn smart world kì 1 năm học 2022 2023 unit 1.doc
 
Individual Performance Commitment Review Form-Developmental Plan.docx
Individual Performance Commitment Review Form-Developmental Plan.docxIndividual Performance Commitment Review Form-Developmental Plan.docx
Individual Performance Commitment Review Form-Developmental Plan.docx
 
formative Evaluation By Dr.Kshirsagar R.V
formative Evaluation By Dr.Kshirsagar R.Vformative Evaluation By Dr.Kshirsagar R.V
formative Evaluation By Dr.Kshirsagar R.V
 
SEQUNCES Lecture_Notes_Unit4_chapter11_sequence
SEQUNCES  Lecture_Notes_Unit4_chapter11_sequenceSEQUNCES  Lecture_Notes_Unit4_chapter11_sequence
SEQUNCES Lecture_Notes_Unit4_chapter11_sequence
 
CTD Punjab Police Past Papers MCQs PPSC PDF
CTD Punjab Police Past Papers MCQs PPSC PDFCTD Punjab Police Past Papers MCQs PPSC PDF
CTD Punjab Police Past Papers MCQs PPSC PDF
 
BRIGADA ESKWELA OPENING PROGRAM KICK OFF.pptx
BRIGADA ESKWELA OPENING PROGRAM KICK OFF.pptxBRIGADA ESKWELA OPENING PROGRAM KICK OFF.pptx
BRIGADA ESKWELA OPENING PROGRAM KICK OFF.pptx
 
How to Manage Early Receipt Printing in Odoo 17 POS
How to Manage Early Receipt Printing in Odoo 17 POSHow to Manage Early Receipt Printing in Odoo 17 POS
How to Manage Early Receipt Printing in Odoo 17 POS
 
What is Packaging of Products in Odoo 17
What is Packaging of Products in Odoo 17What is Packaging of Products in Odoo 17
What is Packaging of Products in Odoo 17
 
How to Add a Filter in the Odoo 17 - Odoo 17 Slides
How to Add a Filter in the Odoo 17 - Odoo 17 SlidesHow to Add a Filter in the Odoo 17 - Odoo 17 Slides
How to Add a Filter in the Odoo 17 - Odoo 17 Slides
 
Imagination in Computer Science Research
Imagination in Computer Science ResearchImagination in Computer Science Research
Imagination in Computer Science Research
 

Gmp ayurveda

  • 1. DR. MANISHA GOYAL Assistant professor RASA SHASTRA DEPT. RAJASTHAN AYURVEDA UNIVERSITY JODHPUR(RAJ.)
  • 2. • Shedule “T” Of Drug And Cosmatic Rule 1945.(Rule 157) • "GMP" - A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufactured will have the required quality.
  • 3. AYURVEDA • Rasa shala v/s GMP • Atank rahite deshe--------samyakvatayanopeta divyechitravichitrta l ( R.R.S.6/11-16) Rasa shala prakurvita-----------nana upkaranupeta prakaren sushobhita l (R.R.S. 7/1-8)
  • 4. RASA SHALA Vedha N Vayav ishan Prakshalan Ras Bhairav w E Nair Agney S Pashan
  • 5. objectives • Raw materials used in the manufacture of drugs are - - authentic, - prescribed quality - free from contamination
  • 6. • the manufacturing process is as has been prescribed to maintain the standards • adequate quality control measures are adopted • the manufactured drug which is released for sale is of acceptable quality • the prescribed process of manufacture of drugs should be documented as a manual and kept for reference and inspection.
  • 7. 1st 2nd LIST OF Factory Premises MACHINERY, EQUIPMENT General MANUFACTURING Requirements PREMISES
  • 8. Factory Premises • receiving and storing raw material; • manufacturing process areas; • Quality control section; • finished goods store; • office; • rejected goods/drugs store.
  • 9. General requirements • Location and surroundings • Buildings: • Water Supply: • Disposal of Waste: • Container’s Cleaning: • Stores: • Working space: 9
  • 10. General requirements • Healthy Clothing, Sanitation and Hygiene of Workers: • Medical Services: • Equipment: • Batch Manufacturing Records: • Distribution Records: • Record of Market Complaints: • Quality Control: 10
  • 11. Location and surroundings The factory building for manufacture of ASU medicines shall be- so situated and shall have such construction as to avoid contamination from open sewerage, drain, public lavatory for any factory which produces disagreeable or obnoxious odour or fumes or excessive soot, dust and smoke.
  • 12. 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.
  • 13. - working space to allow orderly and logical placement of equipment and materials to avoid the risk of cross contamination by other drugs or substances. - It is Designed, constructed and maintained to prevent entry of insects and rodents. - Interior surface (walls, floors and ceilings) shall be smooth and free from cracks and permit easy cleaning and disinfection - The sanitary fittings and electrical fixtures in the manufacturing area shall be proper and safe. - Furnace/Bhatti section could be covered with tin roof and proper ventilation, but sufficient care should be taken to prevent flies and dust. There should be fire safety measures and proper exits should be there. - 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.
  • 14. 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
  • 15. 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.
  • 16. 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.
  • 17. 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.
  • 18. Stores Raw material store Packing material store Finished goods store
  • 19. 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 flavours 8. Plant concentrates/ extracts and exudates/resins. • Each container used for raw material storage shall be properly identified with the label 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 labels shall further indicate the identity of the particular supply in the form of Batch No. or Lot No. and the date of receipt of the consignment. • All the raw materials shall be sampled and got tested either by the in-house Ayurvedic, Siddha and Unani experts (Quality control technical person) or by the laboratories approved by the Government and shall be used only on approval after verifying. • The rejected raw material should be removed from other raw material store and should be kept in separate room. Procedure of ‘First in first out’ should be adopted for raw materials wherever necessary. • Records of the receipt, testing and approval or rejection and use of raw material shall be maintained
  • 20. (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. (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 “Quarantine”. After the quality control laboratory and the experts have checked the correctness of finished goods with reference to its packing/labeling as well as finished product quality as prescribed, then it will be moved to “Approved Finished Goods Stock” area. Only approved finished goods shall be dispatched as per marketing requirements. Distribution records shall be maintained as required.
  • 21. Working space The manufacturing area shall provide adequate space- • 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.
  • 22. 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.
  • 23. • 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.
  • 24. Machinery and Equipments • It is 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. List of equipments and machinery recommended is indicated in Part II A. • Proper Standard Operational Procedures (SOPs) for cleaning, maintaining and performance of every machine should be laid down.
  • 25. Batch Manufacturing Records • Manufacturing records are required to provide an account of the list of raw materials and their quantities obtained from the store, tests conducted during the various stages of manufacture like taste, colour, physical characteristics and chemical tests as may be necessary or indicated in the approved books of Ayurveda, Siddha and Unani mentioned in the First Schedule of the Drugs and Cosmetics Act, 1940 (23 of 1940. • Details of transfer of manufactured drug to the finished products store including dates and quantity of drugs transferred along with record of testing of the finished product, if any, and packaging, records shall be maintained. Only after the manufactured drugs have been verified and accepted quality shall be allowed to be cleared for sale. • It should be essential to maintain the record of date, manpower, machine and equipments used and • to keep in process record of various shodhana, Bhavana, burning and fire and specific grindings in terms of internal use.
  • 26. Distribution Records. • Records of sale and distribution of each batch of Ayurveda, Siddha and Unai Drugs shall be maintained in order to facilitate prompt and complete recall of the batch, if necessary. • The duration of record keeping should be the date of expiry of the batch. Certain category of Ayurvedic, siddha and Unani medicines like Bhasma, Rasa, Kupi- pakva, Parpati, Sindura, Karpu/uppu/puram, kushta, Asava-arishta etc. do not have expiry date in contrast their efficiency increases with the passage of time. Hence, records need be maintained upto five years of the exhausting of stock.
  • 27. Record of Market Complaints Manufacturers shall maintain a register to record • all reports of market complaints received regarding the products sold in the market. • manufacturer shall enter all data received on such market complaints, investigations carried out by the manufacturers regarding the complaint as well as any corrective action initiated to prevent recurrence of such market complaints shall also be recorded. • Once in a period of six months the manufacturer shall submit the record of such complaints to the licensing authority. The Register shall also be available for inspection during any inspection of the premises. • Records of any adverse reaction resulting from the use of Ayurvedic, Siddha and Unani drugs shall also be maintained in a separate register by each manufacturer
  • 29. quality control 1) There should be 150 sq. feet area for quality control section. 2) For identification of raw drugs, reference books and reference samples should be maintained. 3) Manufacturing record should be maintained for the various processes. 4) To verify the finished products, controlled samples of finished products of each batch will be kept for 3 years. 5) To supervise and monitor adequacy of conditions under which raw materials, semifinished 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.
  • 30. 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 pharmacopoeias of Ayurveda, Siddha and Unani 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. 11) Quality control section will have a minimum of: One person with Ayurveda /Siddha/ Unani qualification recognized under Schedule II of Indian Medicine Central Council Act, 1970 (84 of 1970). Two other persons one each with Bachelor qualification in Botony/ Chemistry/ Pharmacy could be on part time or contractual basis.
  • 31. PART 2nd Total area for the manufacturung premices:- 1200 Square feet covered area with separate cabins partitions for each activity.
  • 32. • 100 sq.feet area Anjana/Pisti Pills,Kajal,CapsulesOintment • Kharel/End runner/BallMili/Sieves Shifter Avalesh,Sura,Ark,Tail/Ghrit Capsule filling machine and chemical balance etc.equipments Churna / Nasya • 200sq.feet area Manjan/Lepa/Asava / Arishta • Grinder / disintegrator /Pulverisar / a separate area for Bhatti, Powder mixer/Fermentation tanks furnace, boilers, puta, etc. containers and distillation plant • 150sq.feet area Kupi pakava / Ksara / • Bhatti,Karahi/Patila Flask,copper Rod, Parpati / Lavana Bhasma Earthern Satva/Panak / Syrup container,GajPutBhatti,Mufflefurnace EndRunner,ExhaustFan