Fire safety plays an important role within pharmaceutical manufacturing as many hazards are associated with fires and explosions from solvents, chemicals, dust created during processing, electrical equipment, utility systems and/or high temperatures generated through machinery in order to produce the products. If a fire were to occur in a pharmaceutical facility all of the following could happen:…
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Temperature Sensors in Pharmaceuticals | Types, Working and Features
All aspects of the manufacturing, storage and distribution processes of pharmaceuticals are affected very greatly by temperature. Any deviation in temperature can negatively affect the quality, potency and safety of the product. Temperature sensors are extensively used in clean rooms, warehouse and cold chain environments as well as manufacturing equipment to help make sure that the temperature i…
Importance of Personal Protective Equipment (PPE) in Pharmaceuticals
Safety and quality are two inseparable components of pharmaceutical manufacture. At every stage throughout the entire product lifecycle there is a degree of risk to both the individual performing the task and the product being manufactured, whether it be while handling raw materials through the process of packaging the finished product. Personal Protective Equipment (PPE) has been shown to mitiga…
Color Codes for the Gas Cylinders in Pharmaceuticals
Gas cylinders are widely used for various purposes in pharmaceutical industry from sterile operations and laboratory testing to manufacturing and packaging. The gases in the cylinders are stored at high pressure, so these must be handled carefully.
Safety Guards During Handling of Pharmaceutical Equipment
Working pharmaceutical manufacturing can be very dangerous especially if the right precautions are not followed or the working environment is not up to the standard. In every year, various workers in the pharmaceutical industry globally suffer varying forms of injuries that expose them to various risks and even death while handling pharmaceutical equipment. As such, this makes it very crucial to…
SOP for Portable Fire Extinguishers
1.0 OBJECTIVE
To provide procedure for operation and maintenance of portable fire extinguishers.
2.0 SCOPE This procedure is applicable for all portable fire extinguishers in plant.
3.0 RESPONSIBILITY All Department Heads /designee and Manager EHS/ designee.
4.0 ACCOUNTABILITY: HOD of Engineering
5.0 PROCEDURE: 5.1 Different types of portable fire extinguishers are pro…
2.0 SCOPE This procedure is applicable for all portable fire extinguishers in plant.
3.0 RESPONSIBILITY All Department Heads /designee and Manager EHS/ designee.
4.0 ACCOUNTABILITY: HOD of Engineering
5.0 PROCEDURE: 5.1 Different types of portable fire extinguishers are pro…
Checklist for Audit in Safety and Environment Department
1. Are the Safety, Health and Environment Policy available?
2. Is the list of safety equipments available?
3. Check the training schedule for safety for the location. Is it available?
4. Check the record for accidents and verify the action taken.
5. Check the list of safety boxes. Is it updated/
6. Check any safety box – are the safety items like – nose mask, gloves etc. available. Is the ma…
2. Is the list of safety equipments available?
3. Check the training schedule for safety for the location. Is it available?
4. Check the record for accidents and verify the action taken.
5. Check the list of safety boxes. Is it updated/
6. Check any safety box – are the safety items like – nose mask, gloves etc. available. Is the ma…
Checklist for Audit in Environment, Health and Safety (EHS)
1. Is SOP Index available?
2. Is there any obsolete SOP available in the file?
3. Is drawing showing the positions of water hydrant points available in the department?
4. Is drawing showing the positions of wall-mounted fire extinguishers available in the department?
5. Are records for BOD, COD for ETP available in the department?
6. Are there any excursions in the BOD, COD records w…
2. Is there any obsolete SOP available in the file?
3. Is drawing showing the positions of water hydrant points available in the department?
4. Is drawing showing the positions of wall-mounted fire extinguishers available in the department?
5. Are records for BOD, COD for ETP available in the department?
6. Are there any excursions in the BOD, COD records w…
SOP for Handling the Accidents
1.0 OBJECTIVE
To provide a procedure for reporting and investigation of accident/ incident.
2.0 SCOPE This SOP is applicable to all accidents/incidents occurring in factory premises.
3.0 RESPONSIBILITY All Department Heads and Manager EHS
4.0 ACCOUNTABILITY Head of Departments
5.0 PROCEDURE 5.1 Definitions 5.1.1 Accident: An event, which involves loss or damage to the property, plant, machiner…
2.0 SCOPE This SOP is applicable to all accidents/incidents occurring in factory premises.
3.0 RESPONSIBILITY All Department Heads and Manager EHS
4.0 ACCOUNTABILITY Head of Departments
5.0 PROCEDURE 5.1 Definitions 5.1.1 Accident: An event, which involves loss or damage to the property, plant, machiner…
SOP for Medical Checkup
1.0 OBJECTIVE
To provide a guideline to check the health of every employee working in the factory.
2.0 SCOPE Applicable to all employees working in the factory.
3.0 RESPONSIBILITY Dept. Head – Human Resource/ Designee
4.0 ACCOUNTABILITY Head of Department
5.0 PROCEDURE 5.1 All employees should be examined by a qualified physician.
5.2 All personnel shall undergo medical check up prior to employm…
2.0 SCOPE Applicable to all employees working in the factory.
3.0 RESPONSIBILITY Dept. Head – Human Resource/ Designee
4.0 ACCOUNTABILITY Head of Department
5.0 PROCEDURE 5.1 All employees should be examined by a qualified physician.
5.2 All personnel shall undergo medical check up prior to employm…
SOP for First Aid
1.0 OBJECTIVE
To lay down the procedure to render immediate first aid in an emergency to preserve life and assist recovery.
2.0 SCOPE This procedure is applicable for a casualty for any injury or sudden illness before the arrival of a qualified medical expert.
3.0 RESPONSIBILITY All first aid providers.
4.0 ACCOUNTABILITY Head of Department
5.0 PROCEDURE 5.1 First Aid Management 5.1.1 Encourage …
2.0 SCOPE This procedure is applicable for a casualty for any injury or sudden illness before the arrival of a qualified medical expert.
3.0 RESPONSIBILITY All first aid providers.
4.0 ACCOUNTABILITY Head of Department
5.0 PROCEDURE 5.1 First Aid Management 5.1.1 Encourage …
SOP for Safety in Laboratory
1.0 OBJECTIVE
To describe a procedure for maintaining safety in the laboratory.
2.0 SCOPE This procedure applies to the quality control laboratory in the manufacturing facility.
3.0 RESPONSIBILITY 3.1 Officer – Quality control
3.2 Executive –Quality control
4.0 ACCOUNTABILITY Manager - Quality control
5.0 PROCEDURE 5.1 …
2.0 SCOPE This procedure applies to the quality control laboratory in the manufacturing facility.
3.0 RESPONSIBILITY 3.1 Officer – Quality control
3.2 Executive –Quality control
4.0 ACCOUNTABILITY Manager - Quality control
5.0 PROCEDURE 5.1 …
SOP for Handling of the Spillages in the Laboratory
1.0 OBJECTIVE
To clearly lay down a procedure or handling of the spillages in the laboratory to make laboratory neat and clean.
2.0 SCOPE This procedure is applicable to chemical room and instrument rooms of quality control department.
3.0 RESPONSIBILITY 3.1 Doing: Worker (By the guidance of supervisor)
3.2 Checking: Technical Assistant /Executive
4.0 ACCOUNTABILITY Executive /Manager
5.0 PROCED…
2.0 SCOPE This procedure is applicable to chemical room and instrument rooms of quality control department.
3.0 RESPONSIBILITY 3.1 Doing: Worker (By the guidance of supervisor)
3.2 Checking: Technical Assistant /Executive
4.0 ACCOUNTABILITY Executive /Manager
5.0 PROCED…
SOP for Disposal of Wastage and Transfer to ETP
1.0 OBJECTIVE
To lay down a procedure for disposal of wastage and transfer to ETP.
2.0 SCOPE This SOP shall be applicable for all wastage of production and transfer to ETP.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE 5.1 Segregate all in process wastage material and collect in polyba…
2.0 SCOPE This SOP shall be applicable for all wastage of production and transfer to ETP.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE 5.1 Segregate all in process wastage material and collect in polyba…
SOP for Laboratory Safety
1.0 OBJECTIVE
To lay down the procedure for laboratory safety.
2.0 SCOPE This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY Supervisor Quality Control
4.0 ACCOUNTABILITY Sr. Manager Quality Assurance
5.0 PROCEDURE 5.1 Solvent Extraction 5.1.1 Release the pressure developed on shaking in the Separating funnel by Inverting the funnel with the stopper securely held and opening…
2.0 SCOPE This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY Supervisor Quality Control
4.0 ACCOUNTABILITY Sr. Manager Quality Assurance
5.0 PROCEDURE 5.1 Solvent Extraction 5.1.1 Release the pressure developed on shaking in the Separating funnel by Inverting the funnel with the stopper securely held and opening…
