Contract Development
and Manufacturing

Quality control (QC)

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 transfers 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

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