Deviation and Toxicity Management within Pharmaceutical Manufacturing

By Kim Loynes, 31 March 2021

Pharmaceutical companies must adhere to strict manufacturing environments, compliance and approval processes to keep operations under control. However, this can be a considerable challenge. Deviations from processes can impact the safety and reliability of products and imperil the regulatory compliance of products. This can have a direct impact on costs, health, safety and the reputation of the company.

Because deviations are unintentional it often goes undetected which is one reason why it can be so dangerous and difficult to manage. Teams will need to identify the root causes, assess the potential for damage and rectify the problems.

Advanced software and analytics can accelerate all these processes. They can automate the process of identifying deviations ensuring they are spotted at an earlier stage. Automated systems can enable companies to resolve problems more quickly and put processes back on track.

Data analytics can provide insights into toxicity, identifying hotspots, tracking progress and pinpointing remediation techniques. Biotechnology company Numerate, for example, builds predictive analytical models which make forecasts on a range of metrics including toxicity, metabolism and absorption of drugs. This can help a company identify the best candidates to take forward for trials as well as optimising drug use.

Data can also assist in reducing pollution caused by the pharmaceutical industry. Toxicity and pollutants caused by pharmaceuticals is a constant problem. Chiral pharmaceuticals have been linked to serious diseases including cancers, making remediation of toxicity an increasingly important priority. Current remediation efforts focus on sorption and sonolysis biotransformation and advanced oxidation processes (ozonation and photocatalysis). Improved data use can shed more light on a particular problem and provide insights which can help firms reduce their impact.






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