As per DC act what are the required areas for 1. Liquid Orals Mfg Plant , 2. Quality Control , 3. Micro lab
Oral Liquid Preparations:
The following equipments are recommended for the manufacture of oral/internal use
preparations i.e. Syrups, Elixirs, Emulsions and Suspensions, whichever is applicable,
(1) Mixing and storage tanks preferably of Stainless steel or any other
(2) Jacketted Kettle / 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/automatic bottle filling machine.
(7) Pilfer proof cap sealing machine.
(8) Water distillation unit or deionizer.
(9) Clarity testing inspection units.
Area. - A minimum area of thirty square meters for basic installation and ten square
meters for Ancillary area is recommended.
Quality Control Area and Microbiology testing Laboraotory:
- Quality Control Laboratories shall be independent of the production areas. Separate areas shall be provided each for physico-chemical, biological, microbiological or radio-isotope analysis. Separate instrument room with adequate area shall be provided for sensitive and sophisticated instruments employed for analysis.
2 Quality Control Laboratories shall be designed appropriately for the operations to be carried out in them. Adequate space shall be provided to avoid mix-ups and cross-contamination. Sufficient and suitable storage space shall be provided for test samples, retained samples, reference standards, reagents and records.
The design of the laboratory shall take into account the suitability of construction materials and ventilation. Separate air handling units and other requirements shall be provided for biological, microbiological and radioisotopes testing areas. The laboratory shall be provided with regular supply of water of appropriate quality for cleaning and testing purposes.
Quality Control Laboratory shall be divided into separate sections i.e. for chemical, microbiological and wherever required, biological testing. These shall have adequate area for basic installation and for ancillary purposes. The microbiology section shall have arrangements such as airlocks and laminar air flow work station, wherever considered necessary.
THE DRUGS AND COSMETICS ACT, 1940, THE DRUGS AND COSMETICS RULES, 1945
SCHEDULE M- PART-I, GOOD MANUFACTURINGPRACTICES FOR PREMISES AND MATERIALS
PART II - REQUIREMENTS OF PLANT AND EQUIPMENT, GENERAL REQUIREMENTS
(As amended up to the 31st December, 2016)
PLEASE CHECK THE ABOVE REQUIREMENTS AS PER CURRENT RULES.