Report a GMP Concern
If you observe something that may impact Good Manufacturing Practice (GMP),
product quality, data integrity, or compliance expectations, you are encouraged
to report it.
Raising concerns helps the organization identify and address issues early and
supports a strong quality culture.
Examples of GMP concerns may include:
- Practices that do not appear to follow established procedures
- Incomplete, inaccurate, or missing documentation
- Conditions that could affect product quality or patient safety
- Equipment, facility, or environmental concerns
- Pressure to bypass or shortcut required controls
Reporting a concern is encouraged and non-punitive.
You are not required to determine severity or root cause.
Quality Assurance will review and determine appropriate next steps.
How concerns are handled
All reported GMP concerns are reviewed by Quality Assurance.
Concerns may be evaluated as informational, investigated further,
or managed through the Quality Event process when appropriate.
Retaliation for raising a GMP concern is not tolerated.