1 Quality Control
⦁ Supplier qualification and management
⦁ Purchasing agreements/quality agreements
⦁ Incoming goods inspection
⦁ Sampling
⦁ Testing, release and documentation
2 Quality Assurance
⦁ Quality Management Systems
⦁ Process mapping
⦁ Policy
⦁ SOPs
⦁ Wis
⦁ Compliance with GMP/GPD/FDA/ISO
3 Manufacturing/packaging & labelling
⦁ Process mapping
⦁ Design or improve manufacturing processes
⦁ Monitor/witness manufacturing to assure compliance
⦁ Advise om improvements
⦁ Packaging and labelling (line clearance, reconciliation, mixed up, traceability)
4 Batch documentation
⦁ Design or improve batch records
⦁ Review batch records
⦁ Review/investigate/solve manufacturing deviations
⦁ Advise om improvements
5 Shipment, storage and supply
⦁ Process mapping
⦁ If cold chain, shipment validation (2-8 or dry ice)
⦁ Storage (if cold chain temperature monitoring)
⦁ Storage conditions/warehousing, (First Expired First Out)
6 Training
⦁ Increase quality awareness, quality mindset
⦁ Root Cause analyses
⦁ Good Manufacturing Practice
⦁ Good Laboratory Practice
⦁ Good Documentation Practise
⦁ Archiving
⦁ Disposal
7 audits
⦁ Both paper based as on site audits
⦁ Internal audits against any guideline (GMP, ISO, FDA)
⦁ Supplier audit
⦁ Audit of manufacturing (outsourced)
⦁ Audit of contract laboratories
⦁ Audit of warehouses or external archives
8 Regulatory affairs
⦁ Registrations in Europe, US and middle east
⦁ Write or review parts of the dossier
⦁ Registration for medical devices (IVD-IVDR)
⦁ Write or review parts of the dossier