Under Quality assurance and quality control we mainly comprise
- Fixed procedures
- Qualification and validation
- Documentation of the QS system
- Quality and quantity check on receipt of goods
- Control in process during manufacturing
- Documentation of process
- Filing of remaining samples
- check and release of the finished product
- release according to §16 AMWHV (service)
The finshed product is released according to the ARCOŽ specification
Standard parameters are i. a. as follows
- check uniformity of the filling product
- disintegration (Phar. Eur. 2.9.1) and microbiological analysis (Phar. Eur. 2.6.12 and 2.6.13) of total number of germs, yeast and mould absence check of E. coli
- With regard to our quality control and assurance traditional wet-chemical procedures as well as modern chromatography (HPLC, GC) and spectroscopic methods (UV-Vis, IR, photometry) are used.
