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.
- 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,
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.