BIOINDUSTRIA L.I.M. guarantees the highest level of quality in all phases of drug development, manufacture and control.
All production and commercial activity is conducted in accordance with the Good Manufacturing Practices (GMP).
Both FDF and API manufacturing activities are FDA approved.
Good Manufacturing Practices (GMP) ensure that production is carried out in accordance with the highest quality standards, through:
The manufacturing Authorization shall ensure that all products authorized and sold on the market are manufactured only by authorized producers whose activity is subject to regular inspections by the competent authorities.
- Documentation and recording of every aspect of the production process
- Use of specially trained staff
- Systematic verification of the proper functioning of instruments and machinery
- Process validation
- Complaint handling
|DECREE AUTHORIZING NOVI LIGURE AND AUTHORIZED PRODUCTIONS|
|EIR - FDA 2018|
|GMP certificate Novi Ligure|
|API PRODUCTION AUTHORIZATION DECREE|
|GMP Certificate API|