Quality control

Polpharma can rely on a broad range of in-house physical, chemical and
microbiological testing techniques to release the products safely and on time.

Quality control laboratories’ core activities

• Raw materials/intermediates, packaging materials certification
• In process control:
  • Progress of reaction HPLC/UHPLC
  • PSD during milling/micronization
  • IPC tests e.g. chlorides, water content, LOD, pH etc.
  • Residual solvents content GC
• Intermediates and recovered solvents/crude APIs certification
• APIs sampling and Certification
• Analytical methods transfer from Customers / External Labs / R&D
• Specifications and methods approval
• Stability, photostability, and holding time (on-site stability chambers)
• Handling of retain samples
• Qualification of analytical equipment
• Ph. Eur. and USP Pharmacopeia methods verification
• PSD methods development and validation
• Documentation distribution – eDMS system