Pharmaceuticals

Preservation Efficacy Test - Challenge test

Pharmaceutical products should be tested during product development for adequacy of preservation against microbial contamination which may occur under reasonably foreseeable conditions of consumer use. The QACS Laboratory is licensed by the National Organization for Medicines (EOF) for the microbiological testing of pharmaceutical preparations of human and animal use.

Cleaning validation

Demonstration with a suitable quantitative analytical technique (liquid chromatography, LC), that application of routine cleaning procedures to toiletries production equipment (preparation and storage tanks, filling nozzles and utensils) assures the absence of the previously manufactured product. A quality assurance approach is described, from preparation of a suitable protocol of actions, to the qualification of analytical results at detection and quantification limits. Cleaning validation in the toiletries industry . Article published at Analytica Chimica Acta, Volume 467, Issues 1-2 , 3 September 2002, Pages 261-266.

Validation of microbiological methods

Development and implementation of a validation protocol in order to document method suitability.