What does a "deviation" refer to in a GMP environment?

In a Good Manufacturing Practice (GMP) environment, a "deviation" specifically refers to any departure from established standards or procedures. This definition is critical because deviations can impact product quality, safety, and efficacy, which are paramount in the pharmaceutical industry. It's essential to have a systematic approach to documenting, investigating, and addressing deviations to maintain compliance with regulatory standards and ensure that corrective actions are taken.

The concept focuses on compliance with predefined processes; any variation from these processes, even if unintended, requires careful assessment. By identifying and managing deviations, organizations can implement appropriate corrective and preventative actions to minimize risks and enhance overall operational effectiveness.

In contrast, alterations such as successful modifications of controlled procedures or planned changes in production methods typically arise from the need for improvements or innovations and may follow a structured change control process. Temporary adjustments to standard operating procedures are often seen in specific circumstances but do not necessarily align with the definition of a deviation unless formally documented and justified.