Glossary

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The EMA is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).

The US Food and Drug Administration is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, and cosmetics.

Functional Safety pertains to the part of a system’s overall safety that depends on the correct functioning of safety-related systems and other risk reduction measures. It involves the automatic protection system that mitigates hazardous events. It comprises four levels:

• Safety Integrity Level (SIL): Safety Integrity Level is a measure of safety system performance, in terms of the probability of failure on demand. It is used in the context of functional safety standards and denotes the equired risk reduction level provided by a safety function.
• Layers of Protection Analysis (LOPA): Layers of Protection Analysis is a risk management technique used to evaluate the risk and effectiveness of various protection layers in place to prevent or mitigate hazardous events. LOPA involves a semi-quantitative analysis to ensure that the layers are adequate to reduce risk to acceptable levels.
• As Low As Reasonably Practicable (ALRAP): As Low As Reasonably Practicable is a principle in risk management where risks are reduced to a level that is as low as reasonably practicable. This involves balancing the cost and difficulty of risk reduction measures against the benefits of risk reduction.
• So Far As Is Reasonably Practicable (SFAIRP): So Far As Is Reasonably Practicable is a legal standard used in health and safety legislation. It requires that measures to control risk should be taken to the extent that they are reasonably practicable, considering the severity of the risk, the state of knowledge about the risk, and the cost and feasibility of risk reduction measures.

Hazard Identification is a systematic process to identify potential hazards that could cause harm to people, property, or the environment. It is the first step in the risk management process and involves recognising all the hazards associated with a particular activity or process.

Local Exhaust Ventilation is an engineering control system designed to reduce employee exposure to airborne contaminants such as dust, mist, fumes, vapouO&Mrs, or gases in a specific location. LEV systems capture contaminants at or near the source and exhaust them outside the work area.

The Medicines and Healthcare Products Regulatory Agency is a UK government agency responsible for ensuring that medicines and medical devices work and are acceptably safe. It regulates the manufacture, distribution, and supply of these products in the UK.

Operation and Maintenance Manuals are comprehensive documents that provide detailed instructions on the operation, maintenance, troubleshooting, and repair of the constructed asset, equipment or systems. These manuals are essential for ensuring longevity and efficient performance.

PPE refers to protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer’s body from injury or infection. PPE is used in various settings, including healthcare, construction, and manufacturing.

Quality Management Systems are formalized systems that document processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organisation’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency continuously.

Standard Operating Procedures (SOPs) are detailed, written instructions that ensure uniform performance of a specific function. They are essential for ensuring consistent quality and compliance.

Hazard and Operability Study is a structured and systematic examination of a planned or existing process or operation. The HAZOP method is used to identify and evaluate problems that may represent risks to personnel or equipment, or prevent efficient operation. It focuses on identifying deviations from design intent and their possible causes and consequences.

Process Hazard Assessment is a systematic approach to identifying and analysing the potential hazards associated with the processes. The goal is to understand the risks and implement measures to prevent accidents and ensure safe operations.