API's

With the inclusion of API (Active Pharmaceutical Ingredients) manufacture to the EU Guide to Good Manufacturing Practice (GMP), many API manufacturers are being confronted with GMP regulations for the first time.

Annex 18 discusses water specifically, stating that if the API manufacturer treats water to achieve a defined quality, the treatment process should be validated and monitored with appropriate action limits.

ELGA Process Water offers a variety of validated water treatment systems, covering a wide range of flow rates and quality specifications as well as offering support in the validation or revalidation of water treatment systems.

API's

With the inclusion of API (Active Pharmaceutical Ingredients) manufacture to the EU Guide to Good Manufacturing Practice (GMP), many API manufacturers are being confronted with GMP regulations for the first time.

VWS PHARMACEUTICAL GROUP