QUALITY ASSURANCE

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Certifications

The Quality department of PHARMASYNTHESE guarantees quality, traceability, compliance and continuous improvement of operations and performance.

PHARMASYNTHESE is ISO 9001 certified since 1998.

in February 2017, PHARMASYNTHESE was granted the renewal of its GMP certifcate by the French Health agency ANSM. The certificate coverss APIs manufactured at Saint Pierre les Elbeuf facility.

 

Regulatory

PHARMASYNTHESE was granted several CEPs by the European Health Agency for its active ingredients:

 

 

Products Type Date
DIBUCAINE HCL CEP R1-CEP 2007-117-Rev00 March 2015
FENTINAZOLE NITRATE CEP R0- CEP 2015-157-Rev02 June 2017
SERTACONALZOLE NITRATE CEP R0-CEP 2015-066-Rev01 July 2017

 

 

4 APIs are registered into the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and obtained Drug Master File to address Japanese pharmaceutical market.

Audits are conducted on a monthly basis by worlwide pharmaceutical companies.

INABATA France implemented the Good Distribution Practices (GDP) for the distribution of Active Pharmaceutic Ingredients.

We are supplying Pharmaceutical and Cosmetic ingredients in Europe, Japan and the rest of the world.

Every year, an important part of the profits is reinvested into various areas of our production site to upgrade the facility in terms of GMP, EHS and productivity.

Quality control laboratory

The laboratory covers a total surface of 160 m2.

Air and access are controlled.

Employees must use a airlocked dressing room as well as a pass-through window for the transmission of samples and documents.

 

 The laboratory is fully equipped with:

  • 5 HPLC chains
  • 4 GC chains including 2 head space chromatographs
  • 1 IR spectrophotometer
  • 1 UV spectrophotometer
  • 1 polarimeter
  • 1 refractometer
  • 1 DSC (Differential Scanning Calorimetry) instrument

Only a few analyses are subcontracted through a partnership with an academic laboratory: microbiology, particle size assay and NMR/X-Rays.