EU GMP Batch Release Testing & QP Batch Release

According to EU regulations, medicinal drug products imported into European Economic Area (EEA) from third countries have to be re-tested and certified by Qualified Person (QP) in order to be released into the market.  At Profarma we offer batch release testing and QP batch release. We can test chemical, biological, sterile, non-sterile products. 

 

We can offer:

Profarma provides a vast number of analytical services 

  • Raw Material Testing (USP/NF, EP, JP)
  • Finished Product Quality Control Release Testing
  • Stability Testing and Storage
  • Method Development/Method Validation
  • Method Transfer/Method Verification
  • Drug Release/Dissolution Testing

Pharmacopoeia compendial methods

  • pH
  • Appearance: color, clarity/opalescence, odour
  • Solubility
  • Loss on drying 
  • Sulphated ash
  • Extractable volume

Tablets testing (coated and uncoated) and hard capsules

  • Dissolution/disintegration
  • Uniformity of dosage units
  • Water content (KF)
  • Microbial limits (TYMC/TAMC, and the absence of specific objectionable bacteria (e.g., Staphylococcus aureus, Escherichia coli, Salmonella, Pseudomonas).

Testing of oral liquids and injectables

  • Uniformity of dosage units
  • pH
  • Microbial limits (TYMC/TAMC, and the absence of specific objectionable bacteria (e.g., Staphylococcus aureus, Escherichia coli, Salmonella, Pseudomonas)
  • Dissolution
  • Specific gravity
  • Water content (KF)

Other tests

  • Identification tests (e.g. chromatographic methods: RP-HPLC)
  • Purity;  Related substances.
  • Uniformity of mass
  • Assay (RP-HPLC, UV/VIS spectrophotometric method)
  • Microbial quality
  • Bacterial Endotoxins/LAL
  • Sterility Test (in contract laboratory)
  • SDS-PAGE
  • TLC
  • Specific color reactions (Chemical Reactions)
  • ELISA
  • Melting point

Contact us for more

Email or call to get more information and a price quote