Schedule M-I:

Schedules: Schedule ASchedule BSchedule CSchedule DSchedule E1Schedule FSchedule GSchedule HSchedule H1, Schedule I, Schedule JSchedule KSchedule L1Schedule MSchedule M1Schedule M2Schedule M3Schedule NSchedule OSchedule PSchedule QSchedule RSchedule SSchedule TSchedule USchedule V, Schedule W, Schedule XSchedule Y

Schedule M-I:
Schedule M-I describes the good manufacturing practices and  requirements of premises, plant and equipment for homoeopathic medicines.
1.       General Requirements
§  Location and Surroundings
§  Building
2.       Plant and Equipements
§  General
·         Rooms
·         Water
·         Disposal of water
·         Factories Act
·         Medical Services
·         Safety Measures
·         Work benches
·         Container Management
§  Personnel
3.       Requirement of Equipment and Facilities:
3.1   Mother tinctures and mother solutions:
The following equipment and facilities shall be provided:-
(i)                  Disintegrator
(ii)                Sieved separator
(iii)                Balances, weights and fluid measures, all in metric system
(iv)              Chopping table/board and knives
(v)                Macerators with lids (all made of stainless steel of grade 304 or neutral glass)
(vi)              Percolators (all made of stainless steel of grade 304)
(vii)             Moisture determination apparatus
(viii)           Filter press/Sparkler filter (all metal parts shall be of stainless steel)
(ix)              Mixing and storage vessels (Stainless steel of grade 304)
(x)                Portable stirrers (Rod, blades and screws shall be of stainless steel)
(xi)              Water still/water purifier
(xii)             Macerators and percolators for preparing mother solutions of materials of chemical origin.  These shall be  of material, which will not react with the chemicals, used and which  do not bleach
(xiii)           Filling and sealing machine.
 The area and facilities for manufacture of mother tinctures and mother solutions shall be separate and shall be 55 square meters for each for basic installations.
3.2   Potentisation  section :
The section shall have the following facilities:
(i)                  Work benches with washable impervious tops
(ii)                Facilities for orderly storage of different potencies and back-potencies of various  drugs
(iii)               Suitable devices for measuring and dispensing of potencies/back-potencies into the potentisation phials
(iv)              Potentiser with counter.
 An area of 20 square meters shall be provided for basic installations. 
Note:
(a) The requirement of potentiser is not mandatory.  The process may be done manually also with proper SOPs. Potentiser, if used, shall be properly validated and shall be calibrated every time before commencement of work for proper performance.
(b) The manufacturer shall use back-potencies procured from licensed manufacturers and the firm shall maintain proper records of purchase or shall prepare own-back potencies. Every container of potencies and back-potencies shall be kept properly labelled and there shall not be mix-up of different medicines and different potencies.
 3.3 Containers and Closures Section:
Separate area for preparation of containers and closures shall be provided adjacent to the potentisation section.
 This area shall have the following facilities:
(i)                  Washing tanks with suitable mechanical or hand operated brushes
(ii)                Rinsing tanks. Purified water shall be used for rinsing
(iii)               Closures washing / macerating tanks
(iv)              Driers;
 Note:  
(a) Different droppers shall be used only for each different medicine and different potency.
(b) All measures shall be in metric system.  Measures used shall be of neutral glass. Metal droppers and plastic droppers shall not be used.
(c) Glass droppers shall be reused only after proper cleaning and sterilization
(d) Potentisation shall be done by the method(s) prescribed in the Homoeopathic Pharmacopoeia of India
3.4 Trituration, Tableting, Pills and Globules making sections:
The following basic equipment and facilities shall be provided:
(i)                  Triturating Machine
(ii)                Disintegrator
(iii)               Mass Mixer
(iv)              Granulator
(v)                Electrical Oven
(vi)               Tablets punching Machine
(vii)             Kettle (steam or electrically heated ) for preparing solutions
(viii)           Driers for drying granules and tablets
(ix)              Sieved separator (stainless steel)
(x)                Tablet counter
(xi)               Balances
(xii)             Coating Pan with spray-gun
(xiii)           Multi-sifter
(xiv)           Mill with perforations.
 An area of 55 square meters shall be provided  for basic installations. The area shall be suitably divided into cubicles to minimize cross contamination, mix-up etc.
Note: The section shall be free from insects, worms, rodents, dust and other floating particles and moisture.
1.5   Syrups and other oral liquids section:
The following basic equipment and facilities shall be provided:
(i)                  Mixing and storage tanks (stainless steel of grade 304)
(ii)                Portable stirrer (rod, blades and screws shall be of stainless steel)
(iii)               Filter press / Sparkler filter (all metal parts shall be of stainless steel)
(iv)              Filling and sealing machine
(v)                pH meter.

An area of 20 square meters shall be provided for basic installations. The section shall be free from dust and other floating particles, cobwebs, flies, ants and other insects, birds, lizards and rodents.
1.       Adequate number of workbenches shall be provided.
2.       Visual inspection table shall be provided. This shall comprise of a colour con trast background with  lamp  for providing  diffused  light, mounted on a suitable table.

1.6   Ointments and lotions section:
 The following basic equipments and facilities shall be provided:
(i)                  Mixing tanks (Stainless steel)
(ii)                Kettle (steam or electrically heated) for preparing solutions
(iii)               Suitable powder / planetary Mixer
(iv)              Ointment mill / colloidal Mill / Emulsifier
(v)                Filling and sealing machine / Crimping machine
(vi)              Filtering equipment
(vii)             Balance and weights
 A minimum area of 20 square meters shall be provided for basic installations. An ancillary area for washing vessels and equipment  shall be provided.  An ancillary area for heating purposes shall also be provided.

1.7   Ophthalmic preparations section:
 The following basic equipment and facilities shall be provided:
(i)                  Hot air oven, electrically heated, with thermostatic control
(ii)                Laminar Air Flow bench
(iii)               Air Handling Unit with HEPA filters to provide filtered air and positive pressure to the section and air-locks
(iv)              Ointment mill / colloidal mill
(v)                Mixing and storage tanks (Stainless steel of grade 304)
(vi)              Pressure vessels, as may be needed
(vii)             Sintered glass funnels, Seitz Filter / Filter candle
(viii)           Vacuum pump
(ix)              Filling machines for liquids ointments etc.
(x)                Autoclaves with pressure and temperature gauges
(xi)              Necessary workbenches, visual inspection bench, etc.
 Area: Minimum area of 20 square meters shall be provided for basic installations.
Note: -
1. The section shall have a clean room facility of Class 100 specification.
2.  The section shall be air-conditioned and humidity controlled.
3. Entry to the sections shall be regulated through air-locks with differential air pressures with the air-lock adjacent to the section having higher pressure and the first one through which entry is made with the least pressure.
4. Materials shall be passed to the sections through suitable hatches.
5. The personnel shall wear sterile clothing including headgear, which shall not shed fibre.
6. Washing of phials shall be done in separate areas with proper equipment.  Proper facilities shall be provided in the area for washing vessels.
7. Separate area shall be provided for packing and labelling.

2.       Quality Control Division:
·         Functions
·         Personnel
·         Equipment
§  Microscope of suitable magnification and photographic device
§  Dissecting microscope
§  TLC apparatus
§  UV lamp viewer
§  Monopan Digital Electronic Balance
§  Hot air oven
§  Distillation apparatus
§  Water Bath
§  Polarimeter
§  Refractometer
§  Melting point apparatus
§  pH meter
§  Magnetic stirrer
§  Table Centrifuge
§  Muffle furnace / electric Bunsen
§  Moisture determination apparatus
§  U.V. Spectrophotometer
§  Rotary microtome / Section cutting facilities
§  Tablet Disintegration Machine

3.       Raw Materials
·         Raw Material of Plant origin
·         Raw material of chemical origin
·         Raw material of animal origin
·         Sarcodes
·         Nosodes

4.       Procedures
·         Manufacture of Mother Tintures
·         Manufacture of Attenuations
·         Trituration
·         Formulations
·         Medicated insert pallets

5.       Laboratory Controls
6.       Packaging and Labelling
7.       Expiry Date
8.       Standard Operating Practices (SOPs)
9.       Records and Registers




For more detail refer Drug and Cosmetic Act

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