Quality Assurance & Regulatory Affairs
The manufacture and packing of medical products is heavily regulated. FMP is fully compliant with all regulation outlined by the MHRA (Medicines and Healthcare Products Regulatory Agency), the UK’s regulatory body for medical products. Furthermore, all of FMP’s systems and procedures are audited by the notified body SGS Yarsley.
FMP is very proud of its record with regard to outgoing product quality. A significant element of our operations budget is given to the maintenance of our robust quality management systems. The audit records for current and historic performance are available for inspection by our customers at all times and the business is pro-active in encouraging regular customer audits to its site in Lancaster.
The MHRA frequently updates and alters legislation and our Technical Team is available at all times to advise customers with regard to current legislation for both chemical, componentry and pack mandatory graphics relating to the healthcare industry and cosmetics.
Currently, FMP employ eleven people dedicated to quality assurance & control including four qualified chemists.
- Technical file construction
- Assistance with Drug Tariff applications
- Full data & validation support
- Full regulatory support from development to finished product
- Full supply chain traceability
- Over 25 years of medical device & contract manufacture experience
For more information, please see our quality & environmental policy or view our licences & certifications.
You may also be interested in our artwork design services…
We can assist with compulsory regulated labelling that must appear on product packaging. View our artwork design services for further details.