BQG has extensive experience in Operations & Quality Assurance covering Manufacturing core processes and Routine Quality systems.
We assist our customers in their various operational quality assurance tasks. Our consultants can provide tailor-made services to efficiently support quality operations:
- Implementing the latest industry standards and trends: ICHQ8/Q9/Q10, FDA Guidance for Industry,
- Change control, deviations, CAPA, complaints and OOS analysis and remediation,
- Risks analysis,
- Root cause analysis,
- Periodic review,
- GMP documentation streamlining (SOP, Batch record,...)
- Support to regulatory events such as recalls or warning letter.
Contact us to discuss your Operations and/or Quality Assurance project.