Pharmaceutical Laboratory Accreditation

The general criteria for accreditation of pharmaceutical laboratories are contained within ISO/IEC 17025:2005. There is a need for global acceptance of this form of accreditation in Kenyan pharmaceutical laboratories to achieve national and global recognition, as well as conformity against international standard led to the establishment of an accreditation programme for pharmaceutical laboratories under the auspices of Kenya Accreditation service (KENAS).

Requirements for accreditation

Pharmaceutical laboratories seeking accreditation need to comply with the following requirements:

The quality management, scientific and technical aspects of pharmaceutical laboratories as determined by ISO/IEC 17025 regulatory documents which may have been developed by the KENAS Pharmaceutical Technical Committee (KPTC).
Participation in proficiency testing or inter-laboratory comparisons, where possible.