Quality certified by Government Agencies

When working for the pharmaceutical industry, compliance to defined quality standards is mandatory. Within our laboratories the employees of the quality assurance unit implement and enforce the relevant quality standards. In the field of pharmaceutical analysis our laboratories adhere to the current good manufacturing practice as well as the guidelines of the EMA, FDA and ICH. Regular inspections by local authorities verify the compliance of our laboratories. Furthermore, in case of international projects the corresponding national authorities, e.g. the US-FDA, can perform onsite inspections to check the adherence to current GMP regulations.

Our laboratories performing bioanalysis adhere to the good laboratory practice (GLP) according to § 19b clause 1 of the German chemicals act, which is enforced by regular inspections of local authorities.

Furthermore, frequent costumer audits verify the cGMP or GLP compliance of our laboratories.


 

GLP Zertifikat