Service Analysis of Pharmaceuticals
Derived from the Greek word ‘pharmacon’ (Greek: poison, drug, medicine), pharmaceuticals can be agents or preparations of one or several drugs for use in patients (pharmaceutical drugs).
A pharmaceutical drug is „any substance or combination of substances presented as having properties for treating or preventing disease in human or animal or used in or administered to human beings or animals either with a view to restoring, correcting or modifying physiological functions by exerting pharmacologica, immunological or metabolic action, or to making a medical diagnosis.“
For more information see the following pages:
Production and quality requirements according to the international pharmacopeias
The manufacture of pharmaceutical drugs and the quality standards applicable to the raw materials are subject to strict statutory regulations. These are based on the respective pharmacopeias and Good Manufacturing Practice: the European Pharmacopeia (EP), the American Pharmacopeia (USP) and the Japanese Pharmacopeia (JP). The individual pharmacopeias have been harmonised in terms of determination methods for product controls so as to allow for globally consistent legislation.
Pharmaceutical service testing in ifp's laboratory
ifp Institut für Produktqualität offers several of such tests, the main focus area being microbiology and testing of production waters used.
Water for Pharmaceutical Use (WPU)
Due to the significance of processed water in the pharmaceutical industry, either as a product ingredient or as water used in the production process, the quality requirements regarding this important raw material are especially high.
The purity criteria are defined in the monographs of the European Pharmacopoeia (Ph. Eur.) (monographs acc. to Ph. Eur., in current version).
- Purified water (Aqua purificata) is intended for the manufacture of drugs that are not required to be sterile nor pyrogen-free. It is divided into “Purified water in bulk” and “Purified water filled into containers”.
- Highly purified water (aqua valde purificata) is designed for the manufacture of drugs that require the use of water that is of high biological quality.
- Water for injection (aqua ad iniectabilia) is intended for the manufacture of drugs for parenteral use whose solvent is water. There is “Water for injection in bulk“ and “Sterilised water for injection”.
ifp Institut für Produktqualität offers quality checks based on the procedures to be applied according to Ph. Eur. as described below (click on the image below to see the list of methods):
