Key Notes on Revised Schedule M: Plant and equipment

Last Updated on September 22, 2025 by The Health Master

Requirements of Plant And Equipment

Manufacturing pharmaceutical products is a detailed process that requires very specific Requirements of Plant And Equipment for each type of drug.

This is to ensure the final product is safe, effective, and free from any contamination.

Here is a breakdown of the requirements of Plant And Equipment for different kinds of pharmaceutical preparations.

Let’s understand Requirements Of Plant And Equipment required for manufcaturing of pharmaceutical products.

External preparations

(Ointments, Emulsions, Lotions, Solutions, Pastes, Creams, Dusting Powders and such identical products used for external applications)

Equipment recommended:

(1) Mixing and storage tanks preferably of stainless steel or any other appropriate material;

(2) Jacketed Kettle stainless steel container (steam, gas or electrically heated);

(3) Mixer (Electrically operated);

(4) Planetary mixer;

(5) A colloid mill or a suitable emulsifier;

(6) A triple roller mill or an ointment mill;

(7) Liquid filling equipment (Electrically operated); and

(8) Jar or tube filling equipment.

Area- 30 square meters for basic installation and 10 square meters for ancillary area

Oral Liquid Preparations

(Syrups, Elixirs, Emulsions and Suspensions)

Equipment recommended:

(1) Mixing and storage tanks preferably of Stainless steel or any other appropriate material;

(2) Jacketed Kettle or Stainless steel tank (steam, gas or electrically heated);

(3) Portable stirrer (Electrically operated);

(4) A colloid mill or suitable emulsifier (Electrically operated);

(5) Suitable filtration equipment (Electrically operated);

(6) Semi-automatic or automatic bottle filling machine;

(7) Pilfer proof cap sealing machine;

(8) Water distillation unit or deionizer; and

(9) Clarity testing inspection units.

Area- 30 square meters for basic installation and 10 square meters for ancillary area.

Tablets

The Tablet section shall be free from dust and floating particles and may be air-conditioned.

For this purpose, each tablet compression machine shall be isolated into cubicles and connected to a vacuum dust collector or an exhaust system.

For effective operations, the tablet production department shall be divided into four distinct and separate sections as follows:-

(a) Mixing, Granulation and Drying section;

(b) Tablet compression section;

(c) Packaging section (strip or blister machine wherever required); and

(d) Coating section (wherever required).

Equipment recommended (Electrically operated):

Granulation-cum-Drying section

(1) Disintegrator and sifter;

(2) Powder mixer;

(3) Mass mixer or Planetary mixer or Rapid mixer granulator;

(4) Granulator wherever required;

(5) Thermostatically controlled hot air oven with trays (preferably mounted on a trolley) or Fluid bed dryer; and

(6) Weighing machines;

Compression section

(1) Tablet compression machine, single or multi punch or rotatory;

(2) Punch and dies storage cabinets;

(3) Tablet de-duster;

(4) Tablet Inspection unit or belt;

(5) Dissolution test apparatus wherever required;

(6) In-process testing equipment like single pan electronic balance, hardness tester, friability and disintegration test apparatus; and

(7) Air-conditioning and dehumidification arrangement (wherever necessary).

Packaging section

(1) Strip or blister packaging machine;

(2) Leak test apparatus (vacuum system);

(3) Tablet counters (wherever applicable); and

(4) Air-conditioning and dehumidification arrangement (wherever applicable).

Area- 60 square meters for basic installation and 20 square meters for ancillary area is recommended for un-coated tablets.

Coating section

(1) Jacketed kettle stainless steel container or any other appropriate material (steam, gas or electrically heated for preparing coating suspension);

(2) Coating pan (Stainless steel);

(3) Polishing pan (where applicable);

(4) Exhaust system (including vacuum dust collector);

(5) Air conditioning and Dehumidification Arrangement; and

(6) Weighing machine.

The coating section shall be made dust free with suitable exhaust system to remove excess powder and fumes resulting from solvent evaporation.

It shall be air-conditioned and dehumidified, wherever considered necessary.

Area- 30 square meters for coating section for basic installation and 10 square meters for ancillary area.

Penicillin group: Separate area and equipment for mixing, granulation, drying, tablet compression, coating and packing shall be provided for Penicillin group of drugs.

Hypodermic tablets: The manufacture of Hypodermic tablets shall be conducted under aseptic conditions in a separate airconditioned room, the walls of which shall be smooth and washable. The granulation, compression and packing shall be done in this room.

Effervescent and soluble tablets: The manufacture of effervescent and soluble tablets shall be carried out in air-conditioned and dehumidified areas.

Powders

Equipment recommended:

(1) Disintegrator;

(2) Mixer (electrically operated);

(3) Sifter;

(4) Stainless steel vessels and scoops of suitable sizes;

(5) Filling equipment; and

(6) Weighing machine.

In the case of operation involving floating particles of fine powder, a suitable exhaust system shall be provided.

Workers shall be provided with suitable masks during operation.

Area- 30 square meters for the basic installations.

Where the actual blending is to be done on the premises, an additional room shall be provided for the purpose.

Capsules

For the manufacturing of capsules, separate enclosed area suitably air-conditioned and dehumidified with an airlock arrangement shall be provided.

Equipment recommended:

(Hard Gelatin Capsules)

(1) Mixing and blending equipment (electrically or power driven);

(2) Capsule filling units;

(3) Capsules counters (wherever applicable);

(4) Weighing machine;

(5) Disintegration test apparatus; and

(6) Capsule polishing equipment.

Penicillin and non-penicillin sections: Separate equipment and filling and packaging areas shall be provided in penicillin and non-penicillin sections.

In case of operations involving floating particles of fine powder, a suitable exhaust system shall be provided. Manufacture and filling shall be carried out in air-conditioned areas. The room shall be dehumidified.

Area- 25 square meters for basic installation and 10 square meters for ancillary area. (Each for penicillin and non-penicillin sections)

Surgical dressing

(Surgical dressings other than Absorbent Cotton Wool)

Equipment recommended:

(1) Rolling machine;

(2) Trimming machine;

(3) Cutting equipment;

(4) Folding and pressing machine for gauze;

(5) Mixing tanks for processing medicated dressing;

(6) Hot air dry oven;

(7) Steam steriliser or dry heat steriliser or other suitable equipment; and

(8) Work tables and benches for different operations.

Area- 30 square meters for the basic installations. In case medicated dressings are to be manufactured, another room with a minimum area of 30 square meters shall be provided.

Ophthalmic preparations

(Eye Ointment, Eye lotions and other preparations for external use)

For the manufacture of ophthalmic preparations, separate enclosed areas with air lock arrangement shall be provided.

Equipment recommended:

(Manufacturing under aseptic conditions)

(1) Thermostatically controlled hot air ovens (preferably double ended);

(2) Jacketed kettle or Stainless steel tanks (steam, gas or electrically heated);

(3) Mixing and storage tanks of stainless steel or Planetary mixer;

(4) Colloid mill or ointment mill;

(5) Tube filling and crimping equipment (semi-automatic or automatic filling machines);

(6) Tube cleaning equipment (air jet type);

(7) Tube washing and drying equipment, if required;

(8) Automatic vial washing machine;

(9) Vial drying oven;

(10) Rubber bung washing machine;

(11) Sintered glass funnel, Seitz filter or filter candle (preferably cartridge and membrane filters);

(12) Liquid filling equipment (semi-automatic or automatic filling machines);

(13) Autoclave (preferably ventilator autoclave);

(14) Air-conditioning and dehumidification arrangement (preferably centrally air-conditioned and dehumidification system); and

(15) Laminar air flow units.

Area: (1) 25 square meters for basic installation and 10 square meters for ancillary area.

Manufacture and filling shall be carried out in air-conditioned areas under aseptic conditions.

The rooms shall be further dehumidified as considered necessary, if preparations containing antibiotics are manufactured.

(2) Areas for formulations meant for external use and internal use shall be separately provided to avoid mix up.

Pessaries and Suppositories:-

Equipment recommended:

(i) Mixing and pouring equipment;

(ii) Moulding equipment; and

(iii) Weighing machine.

Area- 20 square meters for the basic installation.

(2) In the case of pessaries manufactured by granulation and compression, the requirements as indicated under “item 3 of Tablet” shall be provided.

Inhalers and Vitrallae

Equipment recommended:

(1) Mixing equipment;

(2) Graduated delivery equipment for measurement of the medicament during filling; and

(3) Sealing equipment.

Area- 20 square metres for the basic installations.

Repacking of drugs and pharmaceutical chemicals

Equipment recommended:

(1) Powder disintegrator;

(2) Powder sifter (Electrically operated);

(3) Stainless steel scoops and vessels of suitable sizes;

(4) Weighing and measuring equipment;

(5) Filling equipment (semi-automatic or automatic machine); and

(6) Electric sealing machine.

Area- 30 square metres for the basic installation.

In case of operations involving floating particles of fine powder, a suitable exhaust system shall be provided.

Parenteral Preparations

The whole operation of manufacture of parenteral preparations (small volume injectables and large volume parenterals) in glass and plastic containers may be divided into the following separate areas or rooms, namely-

Parenteral preparations in glass containers

(1) Water management area: This includes water treatment and storage;

(2) Containers and closures preparation area: This includes washing and drying of ampoules, vials, bottles and closures;

(3) Solution preparation area: This includes preparation and filtration of solution;

(4) Filling capping and sealing area: This includes filling and sealing of ampoules or filling, capping and sealing of vials and bottles;

(5) Sterilisation area;

(6) Quarantine area;

(7) Visual inspection area; and

(8) Packaging area.

Equipment recommended:

Water management area

(1) Reverse Osmosis (RO) or Electro-deionisation (EDI) water treatment unit;

(2) Distillation (multi column with heat exchangers) unit;

(3) Thermostatically controlled water storage tank;

(4) Transfer pumps; and

(5) Service lines for carrying water into user areas through continuously circulating pipe work loop. The Material of Construction (MOC) for the storage tank and circulating pipe line shall be of SS-316 L Grade.

Containers and closures preparation area

(1) Automatic rotary ampoule or vial or bottle washing machine having separate air, water, distilled water jets;

(2) Automatic closures washing machine;

(3) Storage equipment for ampoules, vials, bottles and closure;

(4) Dryer or steriliser (double ended);

(5) Dust proof storage cabinets; and

(6) Stainless steel benches or stools.

Solution preparation area

(1) Solution preparation and mixing stainless steel tanks and other containers;

(2) Portable stirrer;

(3) Filtration equipment with cartridge and membrane filters or bacteriological filters;

(4) Transfer pumps; and

(5) Stainless steel benches or stools.

Filling, capping and sealing area

(1) Automatic ampoule or vial or bottle filling, sealing and capping machine under laminar air flow work station;

(2) Gas lines (Nitrogen, Oxygen and Carbon di-oxide), wherever required; and

(3) Stainless steel benches or stools.

Sterilisation area

(1) Steam steriliser (preferably with computer control for sterilisation cycle along with trolley sets for loading or unloading containers before and after sterilisation);

(2) Hot Air steriliser (preferably double ended); and

(3) Pressure leak test apparatus.

Quarantine area

(1) Storage cabinets; and

(2) Raised platforms or steel racks.

Visual inspection area

(1) Visual inspection units (preferably conveyor belt type and composite white and black assembly

supported with illumination); and

(2) Stainless steel benches or stools.

Packaging area

(1) Batch coding machine (preferably automatic);

(2) Labeling unit (preferably conveyor belt type); and

(3) benches or stools.

Area- (1) Small Volume Injectable: 150 square meters for the basic installation and an ancillary area of 100 square meters.

Large Volume Parenterals: 150 square meters each for the basic installation and for ancillary area.

These areas shall be partitioned into suitable enclosures with airlock arrangements.

(2) Areas for formulations meant for external use and internal use shall be separately provided to avoid mixup.

(3) Packaging materials for large volume Parenteral:  100 square meters.

Parenteral preparations in plastic containers by Form-Fill-Seal or Blow, Fill-Seal technology

The whole operation of manufacture of large volume parenteral preparations in plastic containers including plastic pouches by automatic (all operations in one station) Form-Fill-Seal machine or by semi-automatic blow moulding, filling-cum-sealing machine may be divided into following separate areas or rooms, namely-

(1) Water management area;

(2) Solution preparation area;

(3) Container moulding-cum-filling and sealing area;

(4) Sterilisation area;

(5) Quarantine area;

(6) Visual inspection area; and

(7) Packaging area.

Equipment recommended:

Water management area

(1) RO or Electro-deionisation (EDI) water treatment unit;

(2) Distillation unit (multi column with heat exchangers);

(3) Thermostatically controlled water storage tank;

(4) Transfer pumps; and

(5) Service lines for carrying water into user areas through continuously circulating pipe work loop. The Material of Construction (MOC) for the storage tank and circulating pipe line shall be of SS-316 L Grade.

Solution preparation area

(1) Solution preparation and storage tanks;

(2) Transfer pumps; and

(3) Cartridge and membrane filters.

Container moulding-cum-filling and sealing area

(1) Sterile Form-Fill-Seal machine (all operations in one station with built-in laminar air flow work station having integrated container output conveyor belt through pass box); and

(2) Arrangement for feeding plastic granules through feeding-cum-filling tank into the machine.

Sterilisation area

Super heated steam steriliser (with computer control for sterilisation cycle

along with trolley sets for loading or unloading containers for sterilisation).

Quarantine area

Adequate number of platforms or racks with storage system.

Visual inspection area

Visual inspection unit (with conveyor belt and composite white and

black assembly supported with illumination).

Packaging area

(1) Pressure leak test apparatus (pressure belt or rotating disc type);

(2) Batch coding machine (preferably automatic); and

(3) Labeling unit (preferably conveyor belt type).

Area- (1) 250 square meters for the basic installation and an ancillary area of 150 square meters for large volume parenteral preparations in plastic

containers by Form-Fill-Seal technology is recommended. These areas shall be partitioned into suitable enclosures with air-lock arrangements.

(2) Areas for formulations meant for external use and internal use shall be separately provided to avoid mix up.

(3) Packaging materials for large volume Parenteral: 100 square meters.

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Compiled by:
Rakesh Dahiya, Asstt. State Drugs Controller, FDA Haryana

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Area required for manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre

Manufacturing area / section	Area prescribed for basic installations (Square Metre)	Ancillary Area prescribed (Square Metre)	Total Area required (Square Metre)
Allopathic drugs
External Preparations	30	10	40
Oral Liquid Preparations	30	10	40
Tablets (uncoated) Non-Beta Lactum (Granulation + compression + packaging etc)	60	20	80
Coating (Non-Beta Lactum)	30	10	40
Tablets (uncoated) Beta Lactum (Granulation + compression + packaging etc)	60	20	80
Coating (Beta Lactum)	30	10	40
Powders (oral)	30	–	30
Hard Gelatin Capsules (Beta-lactam)	25	10	35
Hard Gelatin Capsules (Non Beta-lactam)	25	10	35
Ophthalmic Preparation	25	10	35
Eye ointment, Eye lotion	25	–	25
Pessaries	20	–	20
Inhalers & Vitrallae	20	–	20
Re-packing of drugs	30	–	30
Parenteral (Small Volume Parenteral)	150	100	250
Parenteral (Large Volume Parenteral)	150	150	300
Plastic (LVP) by Form-Fill-Seal / Blow, Fill –Seal technology	250	150	400

Homoeopathic
Mother tincture and mother solutions	55	–	55
Potentization section	20	–	20
Trituration, Tableting, Pills and Globules section	55	–	55
Syrups & other oral liquids	20	–	20
Ointments & lotions section	20	–	20
Ophthalmic Preparations	20	–	20
Packing & labelling	50	–	50

Cosmetics
A. Powders	15	–	15
B. Skin powder for infants	15	–	15
C. Creams, Lotions, Shampoo, Shaving Creams, Hair Oils, Emulsions, Pastes, Cleansing Milk, Pomade	25	–	25
D. Nail Polish and Nail Lacquers	15	–	15
E. Lipsticks and Lipgloss	15	–	15
F. Depilatories used for eyes	10	–	10
G. 1. Eyebrows, Eyelashes, Eyeliners 2. Kajal and Surma	10 10	– 5 For base sterilization	10 15
H. Aerosols	15	–	15
I. Alcoholic Fragrance Solutions	15	–	15
J. Hair Dyes	15	–	15
K. Tooth powders general	15	–	15
L. Toilet Soaps	100	–	100

Blood Bank / Centre
Blood Bank / Centre (only for Whole Human Blood)	100	–	100
Blood Component	50	–	50
Blood Bank / Centre including Blood Components	150	–	150
Apheresis	10	–	10

Medical Devices

Area not prescribed in MDR 2017 for manufacturing of Medical Devices

Medicinal Gas

Area not prescribed for manufacturing of Medicinal gases

Disinfectant

Area not prescribed for manufacturing of Disinfectants

API (Bulk drug)

Area not prescribed for manufacturing of API (Bulk drugs)

Empty Capsule Shell

Area not prescribed for manufacturing of Empty gelatin Shell

Soft Gelatin Capsules

Area not prescribed for manufacturing of Soft Gelatin Capsules

Cytotoxic substances / Sex hormones

Same area required as defined for tablet section

Laboratory

Area for Commercial Laboratory or Laboratory for manufacturing units not prescribed

Note: Requirement of ancillary area shall not apply to the units registered before 30-06-2005

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Compiled by:

Lalit Kr. Goel, SDC, FDA Haryana

Rakesh Dahiya, ASDC, FDA Haryana

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Download area requirement

Click below link to download the requirement for the manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre

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