The Critical Roles of Categorisation & Classification
Pharmaceutical products are categorised based on the chemical characteristics of their active ingredients. This ensures patients reap the maximum possible benefits of the drug whilst minimising the potential risks.
The process of categorisation and classification is vital when handling pharmaceutical products for several reasons:
Regulatory Requirements:
Pharmaceutical products must meet strict regulatory requirements from regulatory bodies including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These agencies require drugs to be classified according to their chemical structure, therapeutic use, and potential risks and benefits.
Before processing begins, Almac assesses the health and safety implications of an Active Pharmaceutical Ingredient (API). The molecule’s OEL (occupational exposure limit) is then used to assign it to one of five categories to form a detailed process risk assessment.
Safety and Efficacy:
Categorisation and classification help ensure that drugs are safe and effective for their intended use. By classifying drugs according to their intended use, researchers can design clinical trials that test the drug’s safety and effectiveness in specific patient populations. At Almac, we apply risk-based containment/PP strategy for safe handling and comply with EMA guidance on setting health-based exposure limits in shared facilities.
Prescribing and Dispensing:
Healthcare professionals use categorisation and classification to help prescribe and dispense drugs appropriately. By classifying drugs according to their therapeutic use, healthcare professionals can choose the most suitable drug for their patients and ensure it is prescribed and dispensed safely.
Manufacturing:
Organisations involved in the discovery, development, manufacturing, or packaging of pharmaceutical materials must ensure they are doing so in the most appropriate manner. Applying the necessary quality standards is essential throughout all operations. Categorising drugs according to their chemical structure ensures manufacturers can use the most suitable manufacturing processes and equipment.
Our state-of-the-art facilities, equipment and technology allow us to handle a diverse range of Active Pharmaceutical Ingredients (APIs), including high potent compounds. We routinely process compounds with an OEL of 0.05μg/m3/8hrs, with batch sizes ranging from 0.1kg to 100kg.
By following rigorous containment protocols, we can protect both our employees and the environment while working with potent compounds.
Find out more about our potent processing and manufacturing capabilities today.
