Risk Assessment as a Process Quality Assurance Tool

Abstract

Environmental contamination control is a critical component of sterile pharmaceutical manufacturing, and Risk Management is necessary to ensure that the correct control practices are in place. The Risk Management process is a series of steps, including risk assessment, that allows for a deeper understanding of the manufacturing environment. Removing, reducing, or monitoring activities associated with a product or process to mitigate risk may be the result of such an assessment. This qualitative risk assessment can be transformed into a quantitative evaluation using modern risk analysis tools and procedures; these tools deliver the fully documented rationale behind the path chosen.

The Concept of Risk in Pharmaceutical Production

In the released draft of EU GMP Annex 1, Revision 12, the importance of risk management (Risk Management) is highlighted as an appropriate tool for ensuring the quality of a process. The draft is explicit about the necessity of risk management for sterile drug manufacturers, and it also widely recommends risk management for other product types, especially where control of microbial, particle, and pyrogen contamination is required (e.g., certain liquids, creams, ointments, and low bacterial intermediates) [1].
The production and use of a drug (medicine) and its components necessarily involves a certain degree of risk. It is important to understand that product quality must be maintained throughout the product life cycle. This ensures that the attributes important to the quality of the drug (Critical Quality Attributes) remain consistent throughout the development and production phases of the drug. According to ICH Q6A, drug quality refers to the suitability of a drug substance or drug product for its intended use [5].
In general, a risk management procedure focuses on analyzing each process in a product life cycle with the intent to perform an assessment, mitigation, and review of the associated risks over time. As defined in ICH Q9, risk assessment is a systematic process of organizing information to support risk decisions that are made as part of a risk management process [2].

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