This paper shares best practices in EQMS and how to manage the unexpected to increase efficiency and reduce risk in future operations.
Unanticipated, unpredicted, unplanned, unexpected. These words can be undesirable descriptors of many actions or events, but among pharmaceutical quality and compliance professionals, they elicit downright fear.
In this environment, the occurrence of unexpected events signals that something in their organization’s processes or procedures is not completely under control and could possibly have a detrimental impact on product quality and patient safety. For this highly regulated industry, such occurrences not only carry risk, they have regulatory implications.
The FDA’s 21 CFR 211.192, states that any unexplained discrepancy must be investigated, and that the investigation will extend to all batches related to that issue, which can have a huge time and cost impact. EudraLex, The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the World Health Organization (WHO), and other agencies around the globe have similar standards and guidances.
These pressures will only increase as regulatory bodies shift their focus beyond compliance to quality, and more specifically, to the sustainability of quality within pharmaceutical organizations. This means that an organization’s quality system needs to be built around the ability to identify and address the unexpected if they hope to meet regulatory expectations.