Certified Pharmaceutical GMP Professional 2025 – 400 Free Practice Questions to Pass the Exam

In the context of Good Manufacturing Practices (GMP), a deviation refers to a departure from an established standard operating procedure or protocol. This can occur when a process, procedure, or instruction is not followed as outlined in the relevant documentation. Such deviations can arise from various factors, including human error, equipment malfunction, or unforeseen circumstances.

Understanding deviations is critical in GMP because they can impact product quality, safety, and efficacy. The correct identification and handling of deviations involve documenting the occurrence, investigating the root cause, and taking steps to prevent recurrence. This process ensures that the integrity of the manufacturing process is maintained and that products meet regulatory standards.

While other options might seem related to the concept of production quality or regulations, they do not accurately define what constitutes a deviation in the GMP framework. For instance, a temporary halt in production may be a response to a deviation but is not synonymous with it. Similarly, a new regulation by the FDA is not a deviation but rather a change in legal requirements that manufacturers must comply with. Lastly, referring to a minor issue that does not affect production misrepresents the seriousness of deviations, which can lead to significant quality risks if not properly addressed.