Our products

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