cGMP

The quality distinction of the pharmaceutical and healthcare industries

The demands for quality and security of supply are stringent amongst all of our customers active in the healthcare sector. To comply with these, we maintain dedicated resources for production of healthcare packaging according to GMP (Good Manufacturing Practise) requirements. Premises, equipment, maintenance of machinery, storage of raw materials and production of finished pharmaceutical packs all take place in Flextrus units certified to meet cGMP requirements for the production environment. Flextrus personnel are specially trained for these duties – and their professional skills are being continuously updated.

Our GMP cell meets ISO 9001 standards, with additions from PS9000/ISO15378. A number of fundamental functions are interacting inside the cell:

• Accurate and consistent quality
• Minimized contamination risk
• Minimised risk for mix-up
• Complete traceability
• Hygiene procedures and training of personnel
• Line clearance procedures
• A well-defined production process
• Quality checks with approved test methods and final release
• Delivery certificates
• Extensive claim procedure (fast response for ring-fencing & corrective action)
• Change control - routines for information on parameter changes
• Controlled waste management (i.e. printed material)

To further support your needs to fulfil GMP requirements, we deliver accurate documentation, including traceability information and product technical data with clear material specifications.