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A few years back Harvard Business Review published an article titled ‘The Future of Drug Trials Is Better Data and Continuous Monitoring’. While the article focused on using data and analytics to improve processes across the clinical trial lifecycle, it also touched upon the role of continuous monitoring all the way to the patient, and how several patients respond to a drug. The key takeaway for us, from a safety management perspective, was to use data better to constantly improve all aspects of safety in the pharmaceutical industry. This includes both patient safety and employee safety at the workplace.

There is a greater awareness today about the impact of workplace safety on increased productivity, improved employee engagement, and enhanced brand reputation. The constant evolution of regulatory standards to ensure safe workplaces has also played a significant role in improving EHS processes.

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However, no amount of safety management can be ever enough. Especially in the pharmaceutical industry, the drug development and production lifecycle are filled with several hazards. In addition to the common safety hazards found across industries, the pharma companies also have some unique hazards that necessitate continuous monitoring and improvement of safety processes all the way to the patient and subsequent feedback.

As a first step, Occupational Safety and Health Administration (OSHA) identifies laboratory risk in the pharma sector (and other industries which operate labs) as follows:

  • Chemical Hazards
    • Biological Hazards
    • Biological Agents (other than Bloodborne Pathogens)
    • Biological Toxins
    • Bloodborne Pathogens
    • Animals used for research
    • Biological Safety Cabinets (BSCs)
  • Physical Hazards
  • Ergonomic Hazards
  • Ionizing Radiation
  • Non-ionizing Radiation
  • Noise
  • Safety Hazards
    • Autoclaves and Sterilizers
    • Centrifuges
    • Compressed Gases
    • Cryogens and Dry Ice
  • Electrical
  • Fire
  • Lockout/Tagout
  • Trips, Slips, and Falls

5 Best Practices to Ensure Safety in the Pharma Industry

Safety management is not a one-time effort but requires continuous improvement to meet evolving challenges and make existing processes more effective. Regulatory bodies recommend a risk-based approach to help pharma companies identify risks, prioritize them based on the severity of impact, and implement mitigative measures to minimize or eliminate the risks.

Pharma companies committed to the environment and employee health and safety will benefit by implementing the following five best practices:

Best Practice #1 – Robust Processes to Ensure Laboratory Safety

The laboratory is one of the key work areas in a pharma company that also has high risks due to the usage of chemicals and pathogens in testing and development. OSHA’s detailed guidelines on laboratory safety include:

  • Cleaning up spills quickly
  • Keeping the work area tidy
  • Washing hands frequently
  • Wearing a laboratory coat
  • Not smoking inside the laboratory
  • Labeling containers correctly
  • Wearing eye protection and other personal protective equipment (PPE)
  • Not exposing the skin and keeping it covered always
  • Not eating in the laboratory
  • Regularly checking the glassware to ensure that it is not cracked and that all equipment is safe to use
  • Keeping entryways clear

Best Practice #2 – Ongoing Identification and Analysis of Potential Risks

A risk-based approach helps pharma companies identify potential incidents and analyze their impact on employees, products, and the environment. This can help to be prepared with mitigative measures. It can also improve response times if the risk cannot be eliminated and prepare personnel to handle them efficiently.

Some of the OSHA recommended measures for risk assessment include:

  • Walking around the work area to identify potential hazards
  • Examine accident record sheets to identify trends
  • Identify those who will be impacted if the risk blows out into an event
  • Train them to deal with the risk
  • Eliminate or minimize the risk
  • Record and document the identified risk and the action taken
  • Conduct periodic reviews to ensure the safety measures are maintained to keep the workplace safe

Best Practice #3 – Keep Material Safety Data Sheets

The many hazardous chemicals that pharmaceutical companies work with need to be handled carefully. OSHA’s Hazard Communication Standard mandates that a material safety data sheet should be provided by the chemical suppliers to the manufacturers containing information about the chemical or the other substances being used. The safety data sheet should contain the following:

  • Identification of the chemical or substance
  • The provider’s contact information
  • Identification of the hazards present
  • Composition and ingredients
  • A toxicology report
  • First-aid measures
  • Handling and storage instructions
  • Disposal information
  • Personal protection requirements

The datasheet should always be available for those working with the chemicals.

Best Practice #4 – Complete and Exhaustive Documentation

Documentation of the entire production workflow is essential to ensure that the employees follow it diligently and avoid unsafe protocol. This will also ensure traceability and visibility, leading to continuous improvement.

Some of the key documents needed from a safety management perspective include:

  1. Safety policy document
  2. Process Hazards Analysis (PHA) documentation
  3. ICH Q7 (Good manufacturing practice for active pharmaceutical ingredients) documentation
  4. Risk Management Plan
  5. Quality assurance documentation
  6. Permit to Work documentation

Best Practice #5 – Total Employee Involvement

A great safety management system is only as good as its successful implementation. This requires every employee to be aware of the risks and be equipped to handle them efficiently. This requires top management’s commitment to lead the way in safe behavior and should be emulated till the last worker on the shop floor. Proper training and awareness creation are crucial to empower the employees with behaviors and capabilities to handle events and near misses.

ComplianceQuest EHS to Create a Culture of Safety

The ComplianceQuest Environment, Health, and Safety Management (EHS) Software is aligned with the OSHA requirements. It helps businesses take a risk-based approach in inculcating a safety culture with continuous improvement and data at the core.

A cloud-based solution built on the Salesforce platform- CQ EHS provides end-to-end visibility into safety processes across the organization by seamlessly integrating with other enterprise software such as ERP, CRM, eQMS, PLM, and so on.

From identifying/analyzing risks to establishing safety protocols, documenting processes, training employees, and automated incident management, the solution provides a comprehensive safety management solution. It also makes it easy to digitally transform audit and supplier management workflows and processes across the value chain.

To know more about how the ComplianceQuest EHS software can help you adopt the safety best practices in your organization, visit: https://www.compliancequest.com/work-health-and-safety-management-system/

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