Improvements in Processing and Manufacturing at CeramTec
As many of you already know, with effect from February 2003 CeramTec together with two of its customers has been successful in obtaining FDA approval for the supply of ceramic inserts to the USA. Such approvals were not easy to obtain. This paper discusses what CeramTec has done to achieve these objectives.
Unable to display preview. Download preview PDF.
- 1.H-G Pfaff, GMP Compliant Quality Management Systems—A Contribution to Product Satety, in: Bioceramics in Joint Arthroplasty (eds JP Garino and G Willmann), pp 34–36, Georg Thieme, Stuttgart, 2002.Google Scholar
- 2.FDA Quality System Regulation (21 CFR Part 820)Google Scholar
- 3.FDA Guidance Document on General Principles of Process ValidationGoogle Scholar
- 4.FDA Guidance Document on General Principles of Software ValidationGoogle Scholar