cGMP and Regulatory Updates

1.0 PURPOSE :- To lay down a procedure for personal hygiene at workplace. Explanation :- Personal hygiene is of great importance in preventing body contamination with extraneous, potentially harmul agents such as chemicals and dusts. 2.0 GUIDELINES :- 2.1 Wash your hands thoroughly with soap and water or specially approved cleaning agents, after leaving the work area. 2.2 Do not eat or store foodstuffs in work areas. Do not keep food items in refrigerators where chemicals and biological materials are stored. 2.3 Change clothes immediately if they get contaminated with chemicals and wash the affected part of your body with plenty of water. 2.4 Avoid wiping arms and hands to dirty cloth or to common towel. 2.5 Keep wash rooms, tollets, drinking water fountains clean and sanitary.

SYSTEM CONTROL 1.1 Fluid bed Dryers are quite hazardous from explosion point of view. Drying of hybrid mixtures in the equipment makes it more hazardous. Such dryers must therefore be properly designed and suitably located as to facilitate free venting from explosion relief zone in event of a dangerous situation. 1.2 High air velocities for fluidization, attribute to high electro-static changes on the material being dried and dryer bags. The dryer must therefore be adequately earthed. Synthetic cloth have capacity to accumulate electro-static charges to a dangerous level. Proper risk assessment has to be made, if such cloth are to be used as an exception. 1.3 Every fluid bed dryer must have an explosion relief device of the required size. 1.4 In case of hybrid mixture, concentration of the vapours in the air must not exceed 25% of L.E.L (Lower Explosion Limit), of the solvent at any givven time during drying operation. Drying char...

1.0 OBJECTIVE 2.0 SCOPE 3.0 RESPONSIBILITY 4.0 PROCEDURE To operate the extinguisher , remove the guard cap and strike the plunged against a hard surface like the floor keep the cylinder inverted. Direct the jet emerging from the nozzle on the base of fire. When the plunger is struck , it breaks the acid phial (bottle ) . The sulphuric acid and sodium bicarbonate solution react together to release carbon dioxide (CO 2 ) The CO 2 generated creates pressure which forces the water out of the extinguisher . Note : the CO2 acts only as a propellant and water extinguishes the fire cooling effect.

1.0 OBJECTIVE 2.0 SCOPE 3.0 RESPONSIBILITY Q.C. Officer , Q.C. In-charge . 4.0 PROCEDURE 1. Carry the extinguisher to the place of the fire. 2. Remove the safety pin and operate the discharge device or unscrew the valve depending on the design. 3. Direct the jet at the base of the fire , starting at one edge and sweeping across the surface of the burning material. 4. When used in open air , the operator stand on the up- wind side of the fire and apply the gas in a downwind direction as close as possible to the fire. 5. On fires in electrical equipment first switch off the current. 6. Then direct the jet or horn straight at the fire.

1.0 PREAMBLE : The air in working areas is frequently contaminated by chemical dust, gases and vapours. If the concentration of the air contaminants exceeds permissible level, it can constitute a danger to health. It necessary to carry out investigation of the ambient air with analytical instrument (s) which would determine very small concentrations of hazardous substances within a short time so that prompt actions are taken to reduce the contaminant concentration to a safe level by suitable measures, such as providing effective ventilation, sealing of the reaction vessels etc. 2.0 Some of the reaction equipment available in the world market are described in brief : 2.1 Gases and vapour contaminants :-Detector tubes are available for many of the gases found in the work environment. The gas detector system uses glass tubes filled with gas-typical reagents absorbed on soild reagent carrier. When using with gas-typical reagents absorbed on solid...

1.0 PURPOSE :- To provide guidelines to handle materials within the factory premises and certain minimum precautions required to be observed when handling and transporting materials. EXPLANATION :- All materials, particularly those known to be hazardous, should be handled according to laid down safety procedures as specified by the manufactures or suppliers to avoid accidents and minimise health hazards. The Guidelines here cover care to be exercised during transfer of flammable solvents and corrosive or toxic materials from tanker vehicles to storage tanks, transportation of such materials to process area, movement and handing of materials at various stages of production. 2.0 GUIDELINES : For handling tanker loads. 2.1 Provide approved grounding (earthing ) system when flammable material is involved. Ensure earthing wires are attached and coupled with the outlet tanker valve and inlet hose-pipe of the receiving storage tank. Allow sufficient...

1.0 OBJECTIVE To maintain First Aid Box . 2.0 SCOPE For emergency first aid. 3.0 RESPONSIBILITY Concern supervisor / chemist, Q.C. Incharge 4.0 PROCEDURE 1. Tincture Iodine 2. Mercurochrome 3. Eye wash solution ( Optrex ) 4. Eye Drops (Frutico ) 5. Burnol 6. Soframycin (Oinment ) 7. Sterilised Cotton Wool. 8. Band-aid 9. Jhonshon Tape 10. Anticeptic Solution (Dettol) 11. Paracetamol tablets 12. Nebasulf powder 13. Iodex 14. Pair of Scissor 15. Bandage .