cGMP - the quality distinction of the pharmaceutical and healthcare
To meet the demands for cGMP manufacture in the pharmaceutical and medical device sectors, we maintain dedicated resources for production of healthcare packaging.
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 pharmaceuticals packs all take place in Flextrus units certified to meet cGMP requirements for the production environment. Furthermore, Flextrus personnel are specially trained for these duties, and their professional skills are continuously updated.
Our GMP cell meets ISO 9001 standards, with additions from PS9000/ISO15378. The proof of our effectiveness is that different healthcare customers closely scrutinize our routines - once a month, on average. These on-site audits embrace our different risk management strategies, hygiene, production facilities, distribution and service networks as well as R&D capacity, financial strength and management. We have been audited and approved by such leading companies as AstraZeneca, Abbott Diabetes Care and Glaxo SmithKline.
A number of fundamental functions interacting inside the cell and include:
- 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)
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
We are dedicated to guaranteeing quality and flexibility in all the services we provide to our healthcare customers. We have a sustainable approach with the world of tomorrow in mind. Wherever you are, we will work closely with you to offer extensive knowledge of everything we do – accreditations, customer service, products, deliveries, certificates, laboratories and innovation. We ensure for the material we produce for healthcare packaging maintains stringent hygienic environments, provides accurate on-opack information and offers pack integrity over its shelf life. To this end, we:
- Follow strict procedures for well-defined production control
- Maintain complete operational precision and process control
- Check, re-check and confirm relevant requirements are being met
- Deliver orders according your specifications on-time, all of the time