Pharmaceutical Quality Control

Pharma Control has extensive experience in quality control, enabling us to offer a wide range of chemical and microbiological methods for the control of raw materials and finished products and for the control of water. According to the pharmacopoeia in force (European, American, ...) and to specific folders, Pharma Control performs the following control:

Raw materials

Active ingredients, excipients, packaging items for both physico-chemical tests and assays and microbiological or chemical ones.

Finished product

Physical, chemical and physico-chemical tests : chemical tests of API, preservatives, excipients ; determination of related substances and degradation products, determination of residual solvents ; limit tests (heavy metals, ash,…) ; testing on tablets and capsules (dissolution, friability, hardness, desintegration…)

Microbiological tests : non sterile products, sterility testing, microbia identification (bacteria, yeasts and molds), counting of visible particles, LAL test, pyrogen test, toxicity test, determination of mycoplasma, bioassays, microbiological tests on   antibiotics and vitamins, packaging tests.

Water

Process water, dialysis water, water quality European Pharmacopoeia

 

Regulatory and on-going stability studies

Controlled and monitored ICH storage conditions (standard conditions, semi-permeable conditions, photosensitivity studies)

Planning management

Analytical controls at each terms

Developement of analytical methods

Under the current guidelines (ICH, SFSTP, US), we perform the development and validation of assay methods by :

Liquid and gas chromatography

Spectrophotometry, Titrimetry, Potentiometry

UV-Visible and atomic absorption/emission

Validation of microbiological analysis (Categories, Challenge test, endotoxins,…) according to PE, USP and the Harmonized Methods, validation, sterility tests