Quality performance
Bactimm – Farmalyse achieved accreditation and approval by major regulatory bodies including the Dutch Health Authorities. Based on many years of experience Bactimm – Farmalyse has developed a sophisticated quality management system based on testing of pharmaceuticals and medical devices as well as production of medical devices.
Bactimm
ISO 9001: 2000
The quality management system is applicable to: “microbial research, microbial validation studies and microbial routine quality control laboratory services for cosmetics, neutraceuticals, pharmaceuticals and medical devices” and “product and clean room related microbial consultancy for monitoring activities”.view certificate
ISO 13485: 2003
The quality management system is applicable to: “medical contract manufacturing and filling activities under clean room conditions”.view certificate
GMP-GCLP
Statement on a control laboratory licence, registered in the European Union as a pharmaceutical control laboratory for microbiological analyses by licence number 101347.view certificate
OECD-GLP
According to Directive 88/320/ECC, conformity with the OECD principles of GLP, assessed by The Netherlands GLP Compliance Monitoring Programme.view certificate
Farmalyse
ISO 9001: 2000
The quality management system is applicable to: “contract analyses on pharmaceutical raw materials, excipients and finished products” and “consultancy with reference to pharmaceutical dossiers, methods of analyses and the validation thereof”.view certificate
GMP-GCLP
Statement on a control laboratory licence, registered in the European Union as a pharmaceutical control laboratory for chemical physical analyses by licence number 101037.view certificate