Quality control

OPTIMISING THE QUALITY OF YOUR DRUGS

QUALITY CONTROL: A CONFORMITY GUARANTEE

The quality of a drug is subject to various verifications throughout the production process and life cycle. From the arrival of raw materials in the factory prior to formulation to the post-commercial stability verification, numerous protocols and analytical methods are implemented in order to guarantee the statutory conformity of products and obtain a more in-depth understanding of them, whilst monitoring the slightest variations.

 

QUALITY CONTROLS ON CLINICAL & COMMERCIAL BATCHES

  • Physico-chemical analyses for the verification of raw materials and finished products.
    Example: identification and dosing of active ingredients and their impurities, dissolution, uniformity of content, etc.
  • Reference product analyses (comparatives),
  • Certification of batches and pharmaceutical release with the agreement of the study sponsor (QP release).

 

AN EFFECTIVE, HIGH-QUALITY ENVIRONMENT

The quality control analyses are carried out within the pharmaceutical establishment, which operates a laboratory and equipment compliant with the requirements of Good Manufacturing Practice (GMP). Our staff are also qualified and trained to use the different techniques implemented for this purpose.

 

AUTHORISATIONS/APPROVALS

  • Pharmaceutical and veterinary establishments,
  • Manufacturer of drugs and medical devices intended for human and veterinary use,
  • Manufacturer and importer of experimental drugs intended for human use and veterinary medicines subject to clinical trials,
  • GMP/EMEA.

 

EQUIPMENT ADAPTED FOR VERIFICATION PROCESSES

The SYNERLAB Group possesses a wide range of equipment, particularly liquid chromatographic systems, dissolution devices, UV and IR spectrophotometers and disintegrators.