Quality & Regulatory Affairs
We supply high quality, safe products to meet our customers' requirements at all times
Quality Management System
Bespak operates a Quality Management System (QMS) which is certified as conforming to ISO 13485. Bespak's QMS is designed to be compliant with:
- FDA CFR 21 parts 210 & 211 Current Good Manufacturing Practice
- FDA CFR 21 part 820 Quality System Regulation
- MDD 93/42 EEC Medical Device Directive
Bespak employs a number of techniques to ensure attainment of appropriate quality standards, whilst maximising operational efficiencies. These techniques include:
- Six-sigma
- Continuous Improvement initiatives
- Process capability monitoring, through the use of statistical process control methods
- Effective use of Root Cause methodologies, and comprehensive use of CAPA
Systems are aligned to the principles of ICH 8, 9 & 10 where relevant
Regulatory Affairs
Bespak has extensive experience of DMF submissions supporting Customer NDAa and 510(k) registrations for Disposable Autoinjector and Needle-free Jet Injector products.
In accordance with clients' requirements, Bespak can complete, or assist with, regulatory submissions including collation of Technical Files, undertaking Risk Analysis and Design Validation. Bespak has experience on behalf of its customers, of drafting the relevant CTD sections relating to the device aspects of Drug Product submissions.
Bespak Injectables has received a number of approvals for its technologies in Europe (CE mark; Class IIa and Class IIb) and USA FDA (510(k)).
For more information or to discuss your requirements please click here to contact Bespak.
