Interaction for perfection

Certification according to the GMP standards can be issued only for manufacturers of pharmaceutical products. In order to offer Flextrus healthcare customers quality reassurance at the same level, we will process their packaging material within a GMP cell. This way we can offer:

• Minimized risk for mix-up
• Minimized contamination risk
• Full traceability
• Accurate and consistent quality

The GMP cell meets ISO 9001 standards, with additions from PS 9000/ISO 15378. It has been audited and approved e.g. by customers like Astra Zeneca, Abbot Diabetes Care and Glaxo SmithKline.

Some fundamentals

To ensure the customer and end-user benefits offered by the system, a number of fundamental functions are interacting inside the GMP cell:

• A well-defined production process
• Approved test methods
• Recall procedure
• Line clearance procedures
• Specific sets for production orders
• Release of material after final inspection
• Change control - routines for information on parameter changes

Since documentation is a key parameter, we have taken radical measures to ensure its efficiency:

• Thorough documentation at all stages of operation
• Extended documentation filing (7 years)
• Checklist for documentation
• Documentation of line clearance
• Documented traceability
• Well-defined routines for customer information

In additions to this, operators working within the GMP cell are selected and trained specifically for these duties. Their professional skills are being updated continuously.