A. Requirements of factory premises for manufacture of Homoeopathic preparations:
(1). Location and surroundings: The factory shall be situated in a place which shall not be adjacent to an open sewage drain, public lavatory or any factory which produces a disagreeable or obnoxious odour or fumes or large quantities of soot, dust or smoke. The factory shall be located in a sanitary place, remove from filthy surroundings.
(2). Buildings: The part of the building used for manufacturing shall not be used for a sleeping place and no sleeping place adjoining to it shall communicate therewith except through open air or through an intervening open space. The walls of the room in which manufacturing operations are carried out shall, up to a height of six feet from the floor, be smooth, waterproof and shall be capable of being kept clean. The flooring shall be smooth, even and washable and shall be such as not to permit retention or accumulation of dust. There shall be no chinks or crevices in the walls or floor.
(3). The building used for the factory shall be constructed so as to permit production under hygienic conditions laid down in the Factories Act, 1948 (63 of 1948).
(4). Water Supply: The water used in manufacture shall be pure and drinkable quality, free from pathogenic microorganisms.
(5). Disposal of waste: There should be adequate arrangement for disposal of wastewater and other residues from the laboratory.
(6). The rooms should be airy and clean and the temperature of the room should be moderately comfortable.
(7). Health, Clothing and Sanitary requirement of the Staff: All workers shall be free from contagious or obnoxious disease. Their clothing shall consist of a white or coloured uniform suitable to the nature of the work and the climate, and shall be clean. Adequate facilities for personal cleanliness, such as clean towels, soap and hand scrubbing brushes, shall be provided separately for each sex. The workers shall be required to wash and change into clean footwear before entering the rooms where the manufacturing operations are carried on. Workers shall be required to wear either a clean cap or a suitable headgear so as to avoid any possibility of contamination by air or perspiration.
(8). Medical services: The manufacturer shall provide adequate facilities for First Aid, Medical inspection of workers at the time of employment and periodically check-up thereafter at least once a year.
(9). Working benches: Working benches shall be provided for carrying out operations such as filling, labeling, packing etc. such benches shall be fitted with smooth, impervious tops capable of being washed.
(10). Container management: Where operations involving use of containers such as bottles, phials and jars are conducted, there shall be adequate arrangements separated from potentisation chamber for washing, cleaning and drying such containers, with suitable equipment for the purpose. Wherever these are attended manually adequate precaution of perfection in respect of cleanliness and avoidance of pollutants shall be taken.
B. Requirements of Plant and Equipment:
(a) Mother tinctures. External tinctures and Mother solution section:
The following plant and equipment shall be provided namely: –
Balances and fluid measures
Chopping boards and knives.
Macerators with lid
Percolators with lids and regulated discharge.
Moisture determination apparatus or other suitable arrangement.
Mixing vessels and suitable non-metallic storage containers.
As for as possible metal contacts may be avoided once the drug is processed.
An area of 55 sq. meters is recommended for basic installations.
Adequate separate storage facility should be provided for raw material quarantine, storage and bonded room for alcohol were applicable.
Separate and suitable storage facility should be provided for fresh herbs and odorous raw materials.
Adequate laboratory facility shall be provided for testing of raw material and finished products.
(b) Potentisation Section:
(1) The following arrangements are recommended for container for closure preparation section namely:
Washing tanks with suitable brushing arrangement manual or mechanical.
Purified Water rinsing tank
Closure macerating or washing tanks.
Drying chambers. An area of 20 sq. meters is recommended for basic installation.
(2) The following arrangements are recommended for potency preparation section, namely: –
Working tables with washable top.
Facilities for separate storage of different grades of back potencies.
Suitable measuring devices for discharge of drug and diluent in potentisation vial,
Potentiser with counter or suitable manual arrangement.
Different droppers shall be used for different drugs potencies.
All measuring devices shall be of metric system and be made of glass and shall be free from metallic contents.
It is desired that glass droppers etc. intended for re-use after cleaning should be sterilized by autoclave or heating in a hot air oven.
Plastics, rubber tubes, bulks etc. coming in contact with tinctures or back potencies should not be re-used for other tincture and potencies.
Method of potentisation will be adopted as specified in Homoeopathic Pharmacopoeia of India Vol. I
C. Triturating, Tableting and Pill/Globules section:
The following arrangements are recommended: –
Triturating machine for suitable device
(iii) Mass Mixer
(vi) Tableting punches or machines
(vii) Kettle (Steam/gas/electrically heated) for preparation solution.
(ix) Sieved separator, tablet counters and balances.
Note: – Tablet section shall be free from dust and floating particles. An area of 55 sq. meters is recommended for basis installations
D. Ointments and lotion section:
The following arrangements are recommended namely: –
Kettle (Steam, gas or electrically heated).
Suitable powder mixer
Filling equipment or arrangement.
• An area of 20 sq. meters is recommended for basic installation.
E. Syrups and tonics: –
The following arrangements are recommended namely:-
Mixing and storage tank
Water still / Deioniser
Filling and sealing equipment.
• An area of 20 sq. meters is recommended for basic installations.
F. Ophthalmic Preparations:
The following equipment is recommended for manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-lotion and other preparations for external use, namely: –
Hot air even electrically heated with thermostatic control.
Colloid mill or ointment mill.
Kettle (gas or electrically heated) with suitable mixing arrangement.
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
Autoclaves Adequate precaution should be taken to ensure that the finished product is sterile.
• An area of 20 Sq. meters is recommended for basic installations.
G. Adequate arrangements for space and equipment should be available for labeling and packing.
Please find all articles related to SCHEDULE M below-
[SCHEDULE- M] SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS i.e. EXTERNAL PREPARATIONS (CREAMS, OINTMENTS, PASTES, MULSIONS, LOTIONS, SOLUTIONS, DUSTING POWDERS AND IDENTICAL PRODUCTS), PART –1 D
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