Schedule T: Good manufacturing practices for ayurvedic, siddha and unani medicines


Schedule T (Rule 157):

Schedule T describes the good manufacturing practices for ayurvedic, siddha and unani medicines

The Good Manufacturing Practices (GMP) are prescribed as follows in Part I and Part II to ensure that:
  • Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are 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.
  • To achieve the objectives listed above, each licensee shall evolve methodology and procedures for following the prescribed process of manufacture of drugs which should be documented as a manual and kept for reference and inspection. However, under IMCC Act 1970 registered Vaidyas, Siddhas and Hakeems who prepare medicines on their own to dispense to their patients and not selling such drugs in the market are exempted from the purview of G.M.P.

Part I: Good Manufacturing Practice

1.1 Factory Premises:
The manufacturing plant should have adequate space for: -
I. Receiving and storing raw material
II. Manufacturing process areas
III. Quality control section
IV. Finished goods store
V. Office
VI. Rejected goods/drugs store

1.1. General Requirements
A) Location and surroundings
B) Buildings
C) Water Supply
D) Disposable of Waste
E) Container‘s Cleaning
F) Stores i) Raw material ii) Packaging Material iii) Finished Good Store
G) Working Space
H) Health Clothing, Sanitation and Hygiene of Workers
I) Medical Services
J) Machinery and Equipments
K) Batch Manufacturing Record
L) Distribution Record
M) Record of Market Complaint
N) Quality Control

1.2 Requirement for sterile Product:
A) Manufacturing Area
B) Precautions against contamination and mix

Part II: List

A. List of recommended machinery, equipment and minimum manufacturing premises required for the manufacture of various categories of ayurvedic, siddha system of medicines:

One machine indicated for one category of medicine could be used for the manufacturing of other category of medicine also. Similarly some of the manufacturing areas like powdering, furnace, packing of liquids and Avaleha, Paks, could also be shared for these items.

Minimum manufacturing space required: 1200 Square feet covered area with separate cabins or partitions for each activity. If Unani medicines are manufactured in same premises an additional area of 400 sq. feet will be required.

1. Anjana/Pisti
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Karel/mechanized/motorized, karel. End runner/Ball-Mill Sieves/Shifter.

2. Churna / Nasya/ Manjan/Lepa/ Kwath Churn
Minimum manufacturing space required: 200 sq feet
Machinery/equipment recommended: Grinder/disintegrator/Pulveriser/ Powder mixer/sieves/shifter.

3. Pills/Vati /Gutika Matirai and tablets
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Ball Mill,Mass mixer/powder mixer, Granulator, drier, tablet compressing machine, pill/vati cutting machine, stainless steel trays/container for storage and sugar coating, polishing pan in case of sugar-coated tablets,mechanised chattoo (for mixing guggulu) where required.

4. Kupi pakava/Ksara/ Parpati/LavanaBhasm a Satva/Sindura Karpu/ Uppu / Param
Minimum manufacturing space required: 150 sq. feet
Machinery/equipment recommended: Bhatti, Karahi/Stainless steel Vessels/Patila Flask, Multani Matti/Plaster of Paris, Copper Rod, Earthern container, Gaj Put Bhatti, Mufflefurnace(Electrically operated) End/EdgeRunner, Exhaust Fan, Wooden/S.S.Spatula.

5. Kajal
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Earthern lamps for collection of Kajal, Triple Roller Mill, End Runner, Sieves, S.S.Patila, Filling/ packing and manufacturing room should be provided with exhaust fan and ultra violet lamps.

6. Capsules
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Air Conditioner, De-humidifier, hygrometer, thermometer, Capsule filling machine and chemical balance.

7. Ointment/Marham Pasai
Minimum manufacturing space required: 100sq. feet
Machinery/equipment recommended: Tube filling machine, Crimping Machine/Ointment Mixer, End Runner/ Mill (Where required) S.S. Storage Container S.S.Patila

8. Pak/Avaleh/Khand/ Modak/Lakayam
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Bhatti section fitted with exhaust fan and should be fly proof, Iron Kadahi/S.S. Patila and S.S. Storage container.

9. Panak, Syrup / Pravahi Kwath Manapaku
Minimum manufacturing space required: 150 sq, feet
Machinery/equipment recommended: Tincture press, exhaust fan fitted and fly proof, Bhatti section, Bottle washing machine, filter press / Gravity filter, liquid filling machine P.P. Capping Machine

10. Asava / Arishta
Minimum manufacturing space required: 200 sq. ft
Machinery/equipment recommended: Same as mentioned above. Fermentation tanks, containers and distillation plant where necessary, Filter Press.

11. Sura
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Same as mentioned above plus Distillation plant and Transfer pump

12. Ark Tinir
Minimum manufacturing space required: 100 sq. ft
Machinery/equipment recommended: Maceration tank, Distillation plant, Liquid filling tank with tap / Gravity filter/Filter press, Visual inspection box.

13. Tail/Ghrit Ney
Minimum manufacturing space required: 100 sq. ft
Machinery/equipment recommended: Bhatti, Kadahi/S.S. Patila S.S.Storage Containers, Filtration equipment, filling tank with tap/Liquid filling machine.

14. Aschyotan / Netra Malham Panir/Karn Bindu/Nasa- bindu
Minimum manufacturing space required: 100 sq. ft
Machinery/equipment recommended: Hot air oven electrically heated with thermostatic control, kettle gas or electrically heated with suitable mixing arrangements, collation mill, or ointment mill, tube filling equipment, mixing and storage tanks of stainless steel or of other suitable material sintered glass funnel, seitz filter or filter candle, liquid filling equipment, autoclave.

15. Each manufacturing unit will have a separate area for Bhatti, furnace boilers, puta, etc. This will have proper ventilation, removal of smoke, prevention of flies, insets, dust etc. The furnace section could have tin roof.
Minimum manufacturing space required: 200 sq. ft

B. List of machinery, equipment and minimum manufacturing premises required for the manufacture of various categories of unani system of medicines
One machine indicated for one category of medicine could be used for the manufacturing of other category of medicine also. Similarly some of the manufacturing areas like powdering, furnace, packing of liquids could also be shared for these items.

Minimum manufacturing space required: 1200 square feet covered area with separate cabins, partitions for each activity. If Ayurveda /Siddha medicines are also manufactured in same premises an additional area of 400 square feet will be required.

1. Itrifal Tirya/majoon/ Laooq/Jawarish Khamiras
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Grinder/ Pulveriser, Sieves, powder mixer (if required), S.S. Patilas, Bhatti and other accessories, plant mixer for Khamiras.

2. Arq.
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Distillation Plant (garembic), S.S. storage tank, Boiling Vessel, Gravity filter, Bottle filling machine, Bottle washing machine, Bottle drier

3. Habb (Pills) and tablets
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Ball Mill, Mass Mixer/Powder mixer, Granulator drier, tablet compressing machine, pill/vati cutting machine, stainless steal trays/ container for storage and sugar coating, polishing pan in case of sugar-coated tablets, mechanized chattoo,(for mixing guggul) where required.

4. Sufoof (Powder)
Minimum manufacturing space required: 200 sq. feet
Machinery/equipment recommended: Grinder /pulveriser, Sieves, Trays, Scoops, Powder mixer (where required).

5. Raughan (oils) (Crushing and boiling)
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Oil Expeller, S.S. Patilas Oil filter bottle, Filling machine, Bottle drier, Bhatti.

6. Shiyaf, Surma, Kajal
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: End runner, mixing S.S. Vessel..

7. Marham, Zimad (Ointment)
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Kharal, Bhatti, End runner, Grinder, Pulveriser, Triple Roller Mill (if required).

8. Qurs (Tab.)
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Grinder/Pulveriser, Sieves, Powder mixer (where needed), Granulator, Drier, Tablet Compressing Machine, Die punches Trays, O.T. Apparatus, Balance with weights, Scoops, Sugar Coating Pan, polishing pan, Heater.

9. Kushta
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Bhatti, Kharal, Sil Batta, Earthen pots.
10. Murabba
Minimum manufacturing space required: 100 sq. feet.
Machinery/equipment recommended: Aluminium Vessels 50-100kgs Capacity, Gendna, Bhatti.

11. Capsule
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Pulveriser, Powder mixer (where needed), capsule filling machine, Air conditioner, Dehumidifier, Balance with weights, storage containers, glass.

12. Sharbat and Joshanda
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Tinctum Press, exhaust fan fitted, Bhatti section, Bottle washing machine, Filter Press Gravity filter, Liquid filling tank with tap/liquid filling machine, hot air oven electrically heated with thermostatic control, kettle.

13. Qutoor-e- Chashm and Marham(Eye drops, eye ointment)
Minimum manufacturing space required: 100 sq. feet
Machinery/equipment recommended: Hot air oven electrically heated with thermostatic control, kettle

14. Each manufacturing unit will have a separate area for Bhatti, furnaces, boilers, putta,etc. This will have proper ventilation,removal of smoke, prevention of flies, insects, dust, etc.
Minimum manufacturing space required: 200 sq. feet

C. List of equipment recommended for in-house quality control section:(Alternatively, unit can get testing done from the Government approved laboratory)

(I) Chemistry section
  1. Alcohol Determination Apparatus (complete set)
  2. Volatile Oil Determination Apparatus
  3. Boiling Point Determination Apparatus
  4. Melting Point Determination Apparatus
  5. Refractometer
  6. Polarimeter
  7. Viscometer
  8. Tablet Disintegration Apparatus
  9. Moisture Meter
  10. Muffle Furnace
  11. Electronic Balance
  12. Magnetic Stirrer
  13. Hot Air Oven
  14. Refrigerator
  15. Glass/Steel Distillation Apparatus
  16. LPG Gas Cylinders with Burners
  17. Water Bath (Temperature controlled)
  18. Heating Mantles/ Hot Plates
  19. TLC Apparatus with all accessories (Manual)
  20. Paper Chromatography apparatus with accessories
  21. Sieve size 10 to120 with Sieve shaker
  22. Centrifuge Machine
  23. Dehumidifier
  24. pH Meter
  25. Limit Test Apparatus

(II) Pharmacognosy Section
  1. Microscope Binoculor
  2. Dissecting Microscope
  3. Microtome
  4. Physical Balance
  5. Aluminium Slide Trays
  6. Stage Micrometer
  7. Camera Lucida (Prism and Mirror Type)
  8. Chemicals, Glassware etc.

D. Supplementary guidelines for manufacturing of rasaushadhies or rasamarunthukal and kushtajat (herbomineral-metallic compounds) of ayurveda, siddha and unani medicines:
These guidelines are intended to complement those provided above and should be read in conjunction with the parent guidelines. The supplementary guidelines are to provide general and minimum technical requirements for quality assurance and control in manufacturing Rasaushadhis or Rasamarunthukal and Kushtajat (Herbo-mineral-metallic formulations). These supplementary guidelines deal with Bhasmas, Sindura, Pishti, Kajjali, Khalviya Ras, Kupipakwa, Rasayan, Parpati, Potali Rasa, Satwa (of Metals and Minerals origin) Druti Parpam, Karpu, and Kushta etc. used in Ayurvedic, Siddha and Unani Systems of medicine. The supplementary GMP guidelines for Rasaushadhi or Rasamarunthukal and Kushtajat are needed to establish the authenticity of raw drug, minerals and metals, in process validation and quality control parameters to ensure that these formulations are processed and prepared in accordance with classical texts and for which safety measures are complied. Only those manufacturing units which have Good Manufacturing Practices for ASU drugs and supplementary certificate for Rasaushadhi or Rasamarunthukal and Kushtajat formulations shall be allowed to manufacture the same. Supplementary Good Manufacturing practices Certificate for Rasaushadhies shall be issued by the State Licensing Authority only after thorough inspection by an expert team including Rasashastra experts nominated by the Department of AYUSH

1. Manufacturing Process Areas
2. Quality Control
3. In Process Control
  • Shodhan Register with following details
  • Bhavana and Putta Register with following details
  • Grinding Record Register
  • Packing details
4. Product Quality Control
5. Product recalls
6. Medical examination of the Employee
7. Self-Inspection
8. Dosage form of Rasaushadhis
9. Area Specifications/ requirement for an applicant companies only to have GMP of Rasaushadhis or Rasamarunthukal and Kushtajat (Herbomineral/metallic compounds) of Ayurveda, Siddha and Unani medicines


Schedule TA (Rule 157A):

Schedule TA describes the form for record of utilization of raw material by ayurveda or siddha or unani licensed manufacturing units during the financial year.


For more detail refer Drug and Cosmetic Act

Comments

Contact Form

Name

Email *

Message *

Popular posts from this blog

What are the Schedules under Drug and Cosmetic Act, 1940 & Rules 1945?

State Pharmacy Council, Its Constitution and Composition and Functions

List of WHO:GMP certified pharmaceutical manufacturing companies in Tamilnadu (India)