cGMP and Regulatory Updates

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 .

PURPOSE To provide a procedures for safe use of ladders at work place EXPLANATION Ladders are generally used to reach and work at an elevated point. It is not uncommon to find people using chairs, boxes, broken or unsafe ladders, etc. for climbing. Falls are invitable. Most of the injured may not have even received proper instructions in the safe use of ladders. Guidelines are provided here to use ladders correctly. GUIDELINES 2.1 Inspect ladders before use. Looks out for broken or missing rungs, siderails, oily or greasy step (rungs). Repairs them or replace them f found defective. 2.2 Check feet of ladders to ensurre they are study and not easy to get slipped. 2.3 Select right ladder for a required job. Ladder should not be too long or too short. Appropriate length could be when one can reach to the point of work without over-stretching, standing on the 3 rd or 4 th rung from top. NEVER STEP ON TOP TWO RUNGS....

1.0 PURPOSE The procedure outlined here applies to all maintenance, modification, repair and ------ jobs involving open flame or sparks in all arreas of the factory expect welding shop. 2.0 RESPONSIBILITIES It shall be the responsibility of the issuing authority of the HOT WORK PERMIT (WHP) to ensure that the area where the hot work is required to be carried out is cleared of flammable and combustible materials, and where hot work is required to repair equipment, pipelines, confined space (tanks) etc., they are adequately washed, ventilated and gas tested to ensure concentration of solvent vapours, flammable gases are within the allowable safe limits. It shall be the responsibility of the issuing authority safe limits . it shall be the responsibility of the issuing authority to ensure that the persons who are to carry out the hot job are fully informed of the hazards involved and the precautions to be taken while carrying out the hot work. If work is entrusted to outsi...

Cyanides ( water soluble )- colourless crystals or powders which are soluble in water and react with acids to generate hydrogen cyanide. Cyanides and hydrogen cyanide are extremely poisonous. Both the cyanide solutions and the gas can be absorbed thorough the skin. Whatever the route of absorption, severe poisoning may result. 1.0 SYSTEM CONTROLS :- Handling of highly poisonous compounds, especially cyanides, calls for special regulatory control procedures. Use of such compounds in the laboratory control procedures. use of such compounds in the laboratory should be restricted and only selected group of qualified chemists/analysts should be allowed to handle the materials. Training to cover handling, storage and disposal of cyanides, and in the event of any accident familiarity with first aid procedure s considered essential. 2.0 PROCEDURAL REQUIREMENTS :- 2.1 Handle cyanides with caution. 2.2 Store cyanides in ‘Poison’ cupboar...

1.1 Materials received in drums, boxes, carboys etc. are transported on pallets using hand trolleys, forklift trucks etc. 1.2 Do not throw loaded drum of hazardous chemicals while loading / unloading. 1.3 All flammable liquids must be stored in tightly sealed containers. 1.4 Maintain in the warehousing area, aisle space of atleast one meter for easy movement of materials. 1.5 Ventilate storage room . it is desirable to have exhaust vent (S) just above floor level on one side of the room and make – up inlet (S) on apposite wall. 1.6 Storage room where large where large quantities of liquids are stored must have an emergency exit door, clearly marked. 1.7 Provide portable fire-extinguishers in the area of storage. NOTE :- 1 Strictly prohibit smoking or carrying of any other source of ignition around storage of flammable (e. g. matches). 2 ...

1.0 PURPOSE :- To enumerate a few guidelines for good house keeping at place of work. Explanation : Good housekeeping is very essential for health and safety. Effective housekeeping helps to create orderly and healthy working conditions. 2.0 GUIDELINES :- 2.1 Keep clean and in order the work area and the equipment handled. 2.2 Keep floors dry by washings off and cleanings spillage of oil, chemicals etc. Dipose of oil rages, old paint cans and containers that have held flammable solvents, which are a fire hazard. 2.3 Deposit garbage, wastes, scraps etc. in appropriately marked containers. 2.4 Clean broken lass with a broom and pan. Broken pieces of glass must be picked up from the floor by using a wet cloth and never with bare hands. 2.5 Keep tools clean and store them in their proper places when not in use. 2.6 Do not overcrowd your work table and make it difficult to work. 2...

1.0 PURPOSE :- To outline precautions to be taken while inserting glass rod/tube in rubber tubing, rubber bung or cork during laboratory work. 2.0 GUIDELINES :- 2.1 Ensure that the glass tube end is ground smooth or rounded smooth. 2.2 Choose the rubber tubing to fit glass connection snugly with the end of the tube cut at an angle so that it will stretch easily. In case of bung or cork, make sure to select the correct bore So that insertion can be made without excessive strain. 2.3 Wet the glass tube an rubber tube, bung or cork with water or glycerine. 2.4 Hold rubber tube/bung between the thumb and index finger, not in palm of hand. 2.5 Grasp the glass tube close to the end which is to fit into the rubber tube or bung and push it in with an even pressure using a steady but gentle rotating motion. 2.6 Wear leather or cotton gloves or wrap a towel around the palms and fi...

1.0 EXPERIMENTS : 1.1 Never start an experiment on a bench already crowded with apparatus. 1.2 Avoid leaving a laboratory experiment unattended. 1.3 In case an experiment should be left overnight, involved, the scale of the experiment and the level of the supervision available. Regular supervision by a competent person who has been fully briefed on possible hazards should be arranged. (Danger periods are during initial heating, when approaching boiling points or reaction temperatures, and during additions of further reactants or catalysts). 1.4 Before starting an experiment familiarize yourself and your assistants with all the known hazards of the starting materials and end products. Decide on appropriate safeguard and remidies. Great care must be taken with unknown combinations of chemical reagents. Anything unexpected occurs during your experiment, consult your immediate supervisor. 2.0 Machinery ...