You are viewing the translated version of औषधिको उत्पादन भवनभित्र हुनु पर्ने प्रबन्ध.
(1) General arrangements: There should be minimum arrangements as follows in the building used for the production of medicine:-
(a) With adequate water, clean air and ventilation,
(b) Having the required electric power or required energy,
(c) having provision for the escape of contaminated air or gas,
(d) Having a healthy working environment,
(e) There is an arrangement to throw away, bury, destroy or neutralize the toxicity of the wastes from the production process so as not to harm public health.
(f) Toilets, with adequate water and shower facilities,
(g) Arrangement and provision of means to protect against accidents caused by fire,
(h) the room for storing the raw materials of the medicine, the production room and the storage room for the manufactured medicine are arranged separately, and
(i) Arrangements are made to keep the production rooms clean and tidy at all times.
(2) Special arrangements: In addition to the general arrangements for preparation of parenteral drugs, unauthorized persons should not be allowed to enter the production building, free from dust, germs or micro-organisms. There should be a room that can be done. A clean environment should be maintained in the production room to avoid other pollution. Such a room should be as follows:-
(a) Provision of a separate room for storing raw materials, washing, washing, making solutions, filling and closing containers, sterilizing, packing and labeling and storing prepared medicines. In addition, it is necessary to have the following:-
(1) The floor and wall of the washing room should have a smooth surface so that it can be washed easily and water should not seep through the roof.
(2) The room where jhol is prepared should be washed, the floor, walls and roof should be completely clean and air-conditioned.
(3) In the filling and sealing room, the floor, wall, roof, waterproof and disinfectant bagIt should be made so that it can be washed. In such a room, there should be a system of air control so that dust or germs cannot enter the air through the filter and air cannot enter from the outside, and the room should be under positive pressure.
(4) (a) The room for filling and sealing the medicine without terminal sterilization should be as mentioned in (3) above and there should be arrangements for strict control of micro-organisms. Such as:- arrangements for fumigation etc.
(b) Terminal sterilization of drugs should be as mentioned in (3) above.
(b) There should be arrangements for storing raw materials and prepared medicines without adversely affecting the quality of medicines.