Which statement about GMP components is true?

Which statement about GMP components is true?

• A. Some GMP components may be considered preventive controls based on hazard analysis
• B. All GMP components are always preventive controls
• C. GMP components include marketing and distribution
• D. GMP components do not include warehousing

Answer: (A)

GMP components are baseline manufacturing practices, and under FSMA a preventive control is a specific measure the hazard analysis shows is needed to prevent contamination. Some of these GMP elements can be designated as preventive controls if the hazard analysis identifies a risk that requires a control. That makes the statement true: not all GMP components become preventive controls, but certain ones can be based on what the hazard analysis calls for. Why the other options don’t fit: not every GMP component is always a preventive control, so that broad claim is incorrect. Marketing and distribution aren’t GMP components, which are focused on production and handling practices. Warehousing is typically considered part of GMP-related controls, so saying it’s not included is inaccurate.

GMP components are baseline manufacturing practices, and under FSMA a preventive control is a specific measure the hazard analysis shows is needed to prevent contamination. Some of these GMP elements can be designated as preventive controls if the hazard analysis identifies a risk that requires a control. That makes the statement true: not all GMP components become preventive controls, but certain ones can be based on what the hazard analysis calls for.

Why the other options don’t fit: not every GMP component is always a preventive control, so that broad claim is incorrect. Marketing and distribution aren’t GMP components, which are focused on production and handling practices. Warehousing is typically considered part of GMP-related controls, so saying it’s not included is inaccurate.