Stay cGMP compliant: instrument requalification in pharma

Equipment qualification is more than a one-time event

If you're working in a current good manufacturing practices (cGMP) or other current GxP environment, you know it's critical to keep your equipment in working order. But what does that mean to regulatory authorities? It means that your equipment must be periodically evaluated and validated.

What are the regulatory requirements for GxP?

Regulatory bodies are clear: it's critical to properly maintain an instrument's qualified state. Here are a few examples extracted from regional regulatory guidelines that emphasize this need – qualification is more than a one-time service at the time of installation:

• European Union: "Equipment, facilities, utilities and systems should be evaluated at an appropriate frequency to confirm that they remain in a state of control." (1)
• Global (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use): "Systems and processes should be periodically evaluated to verify that they are still operating in a valid manner." (2)
• United States (FDA): "The equipment and facility qualification data should be assessed periodically to determine whether re-qualification should be performed and the extent of that re-qualification. Maintenance and calibration frequency should be adjusted based on feedback from these activities." (3)
• India: "Qualification and validation should not be considered a one-off exercise. An ongoing program should follow their first implementation and should be based on an annual review." (4)

Five changes that might require requalification

1. Environmental conditions have changed over time. Consider the impact of changes in temperature, humidity, or atmospheric pressure.
2. Equipment has been moved/relocated. Manufacturing lines, electrical power, fixed pipe connections, and even environmental conditions can be dramatically different from room to room, building to building, or when relocating equipment to an entirely new facility.
3. Preventive maintenance, repair, or upgrades have occurred. Replacing spare parts while the instrument is running could affect the specifications. Think about an event that replaces a major component on a system – affecting the wetted flow path and items in the electrical cabinet – or even pressurized air supply, if applicable. How can you confirm that replacing the part didn't disturb any other functions of the instrument?
4. Your needs have changed, which requires a modified binder. Projects and manufacturing needs change over time to meet new demands. The parameters, recording calibrations, and instructions must be updated according to the new utilization.
5. Regulatory guidelines have changed. Maintaining compliance with regulatory bodies is a critical endeavor in GxP environments. Changes to regulatory guidelines require updated documentation.

Why does requalification matter?

Changes can affect your instrument's performance and bring it to an unqualified state – creating risk for your operations:

• You could lose production batches if issues are discovered too late.
• You could waste time and money if you need to backtrack and launch investigations to discover deviation handling.
• You could fail to meet production or research deadlines.

Why select Cytiva for your qualification needs?

Cytiva's equipment service solutions team has specialist knowledge about the instruments Cytiva designs and manufactures and understands how regulations affect the installation and use of the equipment. Our teams keep knowledge up to date as regulatory guidelines change.

With our qualification services you'll benefit from:

• Access to R&D, manufacturing, and engineers.
• Guidance when considering an update to your instrument's hardware or software.
• Our global network of certified Qualification Services engineers, who will ensure timely and efficient qualification.
• Our efficient order-to-deliver process that we've fine-tuned.
• The flexibility to choose hard copy binders or eBinders.
• Updated test results as we compare performance post-qualification with original performance using our installation qualification (IQ) and operational qualification (OQ) services.

Learn more about qualification services from Cytiva.