Quality Risk Management in Pharmaceutical Industry: A Review

This piece intends to outline the foundational principles and practical examples of Quality Risk Management (QRM) tools applicable across various facets of pharmaceutical quality assurance. These facets encompass development, production, distribution, inspection, and the submission of review processes throughout the drug substance, product, and biological product lifecycles. Quality Risk Management represents a comprehensive and ongoing endeavour to reduce risks to product quality throughout its lifecycle, aiming to maximize its benefits while maintaining a risk benefit balance. It is a structured approach for assessing, managing, communicating, and reviewing risks to the product's quality. The core QRM process should encompass the required effort, formalities, and documentation that align with the risk level. The principles of Quality Risk Management are effectively applied in numerous sectors, including business, government, insurance, workplace safety, public health, pharmacovigilance, and regulatory oversight. The risk assessment process involves analysing, identifying, and evaluating risks, followed by the review of QRM strategies.