Quality is one of the most important core values of BIBITEC. Our Quality System ensures GMP-compliant production of your product at the highest savety level.
Our production facilities are subject to constant hygienic monitoring in accordance with international standards.
Our quality system includes:
- GMP Certificate
- Manufacturing Authorisation for APIs intended for clinical trials (phase I-III) in humans
- Well-trained personnel
- Validated analytical methods
- Qualified and calibrated equipment
- Site master file
- Stability testing
- "OOS" procedures, changes according to change control, deviation management via CAPA
- Up to date SOPs, including Change Control and Deviation Control