1. New Facility Setup
Establishment of Quality Management Systems, including:
- SOP
- Staffing of QA and QC departments
- Validation plans (validations of utility systems, manufacturing processes, sanitation, transportation, computer systems, etc.).
- Submission of GMP inspection dossiers (WHO, EU).
2. System Upgrades
- Improvement of quality systems and updates to comply with new GxP guidelines
3. Inspection
- Inspecting suppliers, packaging materials, and service providers.
- Conducting internal inspections.
- Facilitating GMP inspections (WHO, EU, PICs, etc.).
4. Laboratory Services
- Developing standard operating procedures (SOPs) in compliance with GLP.
- Establishing and managing laboratories.
- Developing quality specifications
5. Storage and Distribution
- Developing SOPs in compliance with GSP, GDP, and other relevant guidelines.
- Specializing in the storage and distribution of drugs under special control.
6. Facility Qualification
- Participating in the establishment of quality systems and conducting facility qualification for EU-GMP compliance
