Specifying of Pharmaceutical Products, Cosmetics and Medical Devices in the Accredited Laboratory Certificate of the Bureau of Laboratory Quality Standards, Department of Medical Sciences

Specifying the Scope of Accreditation for Pharmaceutical Products, Cosmetics and Medical Devices

Abstract

         The specification of laboratory accreditation scope of international standards is of considerable importance to the issue of laboratory accreditation certificate according to the ISO/IEC 17025 standard requirements. Accordingly, the Bureau of Laboratory Quality Standards (BLQS) has a policy to determine the pattern and scope of the accreditation referring to the notices of regulatory bodies or identification of specific standards according to the objectives of each service recipient applying for accreditation. However, problems with resolving the accreditation scope have frequently been found both in the processes of pre - and post-accreditation, affecting the duration of the overall process. The purpose of this study was to analyze problems and suggest guidelines for such identification scope, of which patterns and details must be accurate, complete, with the same approach and searchable. The study were compiled from the accreditation applications of drug, cosmetic, and medical device, of 28 from 127 (22.05%) laboratories with comparative data before and after accreditation from 2020 to 2022. Results yielded that the specification was inconsistent with the guidelines and the requirement of the regulatory body in the product samples of cosmetic, medical device, and drug, amounting to 55%, 38%, and 7%, respectively. This study shows that those relevant parties in the laboratory accreditation process do not have a consistent understanding of how to specify the reference of accreditation scope. In addition, there are more variety of health products according to the current situation. Therefore, this data will enable operators and related parties to accurately and clearly identify the accreditation scope to be used for the intended purpose.