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
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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