We provide our expertise to support manufacturing sites and wholesale distributors in maintaining a Quality Management System in line with the Good Manufacturing Practice and Good Distribution Practice guidelines respectively. This is important to ensure that the quality of medicinal products is maintained to the highest standard during manufacture, storage and distribution.
QP services:
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- Solid and liquid non‑sterile oral dosage forms
- GMP audit and inspection
- Batch release
- Manufacture and importation
- Quality Management System (QMS) maintenance
- Process review
- CAPA management
- Supplier qualification
- Deviation investigations
- Quality Risk Assessments
- Oversight of manufacturing processes
- Product quality review
- Quality control
- Interpretation of laboratory data
- Statistical analysis
- Stability results
- OOS management
RP services:
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- GDP audit and inspection
- RP batch release
- Quality Management System (QMS) maintenance
- CAPA management
- Supplier qualification
- Deviation investigations
- Quality Risk Assessments
- Temperature mapping of storage areas
- Validation of Temperature monitoring systems
- Product quality complaint handling
- Recalls
- Quality Management Review
