Growing a pharma business requires a strategic approach considering the specific context of your company and the pharmaceutical industry as a whole. Here are some general pointers to get you started: Market and Customer: Identify your target customer: Deeply understand the specific needs and challenges of your target audience, whether it's doctors, patients, hospitals, or other healthcare providers. This helps tailor your products, services, and marketing efforts. Focus on unmet needs: Look for gaps in the market where existing solutions are inadequate or unavailable. Addressing unmet needs can give you a competitive edge and drive innovation. Track market trends: Stay updated on regulatory changes, technological advancements, and emerging diseases to adapt your approach and anticipate future opportunities. Products and Services: Invest in R&D: Develop innovative products or differentiate existing ones through unique formulations, delivery methods, or combinations. Remember
Schedules: Schedule A, Schedule B, Schedule C, Schedule D, Schedule E1, Schedule F, Schedule G, Schedule H, Schedule H1, Schedule I, Schedule J, Schedule K, Schedule L1, Schedule M, Schedule M1, Schedule M2, Schedule M3, Schedule N, Schedule O, Schedule P, Schedule Q, Schedule R, Schedule S, Schedule T, Schedule U, Schedule V, Schedule W, Schedule X, Schedule Y
For more detail refer Drug and Cosmetic Act
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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