cGMP and Regulatory Updates

1.0 PURPOSE : To provide guideline and appropriate procedure for monitoring and maintenance of fire fighting equipment. EXPLANATION : Fire fighting equipment in an industrial establishment generally consist of the following types: 1. Fire Hydrant System 2. Portable fire Extinguishers 3. Sprinkler system 1. Fire Hydrant System :- Since most of the industrial establishments are covered under fire insurance, the Tarrif Advisory Committee has already laid down certain requirements of a fire Hydrant System in their publication fire protection Manual part II. In the factory Act 1948 and the Maharashtra factory Rules 1963 amended, requirements regarding fire fighting apparatus and water supply are mentioned under various heads such as requirement of water supply based on factory area, requirement of water storage tank capacity, the size of fire Hydrant pump to be installed, periodic testing of the install...

Falls / Accidents If you should fall off the ladder, try not to stiffen your muscles. Try to absorb the shock by bending your arms and legs, lossely, to give spring action when you hit the ground. Roll over to the direction of the fall. First Aid 1.0 Do not move victim when internal injuries or broken bones or injury to neck or spine is suspected. Servere pain in chest, abdomen, legs inability to move, unconsciousness are some of the symptoms. 1.1 Call or medical help immediately, and while waiting for help give first aid for bleeding / shock / breathing failure. (see chapter 8.0 on personnel Health Emergencies)

1.0 PURPOSE :- To provide guidelines or locking out equipment or machinery. Electrical and non-electrical systems are locked out to prevent unexpected energization, start-up or release of stored energy. The lock-out device is a mechanism that allows the use of a padlock to hold switch, lever or valve handle in the “off” position. In the market switches and valves are availables with buit-in lock out device. However, where such arrangement is not available, it should be modified so that locks can be used. 2.0 GUIDELINES :- 2.1 Turn off equipment or machine at the point of operation. 2.2 Isolate the equipment by operating/disconnecting the switch, valve or any other energising device. Ensure stored energy such as rotating fly-wheels hydraulic systems, air or steam pressure etc. are dissipated. 2.3 Lock operation lever in the “off” position with a locking device. If multilock device is provided, then ensure each person involved to place a separate lock retain...

1.0 INTRODUCTION Whenever two dissimilar materials come in contact, a transfer of electrons from one material to the other takes place. As a result, one material acquires an excess of –ve charges and the other an equal excess of +ve charges. If the two materials are now separated, each will carry an excess of charge, and electrostatic charging has taken place. If both materials are conductors (e.g. 2 metals), the high conductivity allows equalization of charges to take place along the contact surface during the separation so that no measurable excess charge is present on complete separation. However, when one of the material involved is non-conductor (e.g. plastics), static charge occurs. NOTE In the case of dust particles or liquid droplets moving in gases, charging is always to be expected, irrespective of the conductivities of the substances involved. When charging process is complete, the excess charge will start to equalise themselves. The discharge take place expone...