Production QMS Support
FormaliS uses its experience to look for answers to your quality management questions.
Activity:
- Support, Consulting and Assistance in current GMPs
- Development of DQ, IQ, OQ, PQs
- Consultancy in BSL 2 & BSL 3 Labs
- Biosafety Issues
Scope:
- Production, packaging and distribution of clinical study batches
- Biotech production – fermentation – upstream – downstream
- Food production
- Specific assignments
Standards:
- current Good Manufacturing Practice (cGMP)
- Annex 13 to GMP
- Local Regulations
- Biosafety Guidelines for Biotech
- HACCP for Food Processing
We offer 4 types of services in 4 different areas.
Our Services:
- Auditing
- Inspection Facilitation
- QMS Support
- Training
Our Areas of Expertise:
- Clinical
- Pre-Clinical
- Production
- Computer System Validation