Main Article Content
The Institute of Biological Products (IBP) has developed a guideline for method validation of testing methods which is imposed systemic direction into quality system creating codes, format, protocol of planning and report of method validation of testing. Therefore, there is the same operation that can control pre-and post-steps of method validation of testing, and it can also be the standard for traceability. As a result, the IBP has good standard operating procedures implemented for method validation of testing. The system has been developed for 14 years, thus the IBP has academic evidences that can prevent errors of testing with inappropriate methods for decision making of product quality that the disqualified products will not be released. The system will support the communication of the IBP which is the National Control Laboratory for controlling biological products and stakeholders, such as manufacturer and importer to understand correctly for all topics. Also, it can be useful for communication between auditors and auditees in laboratory competency assessment.
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
2. ISO/IEC 17025:2017. General requirements for the competence of testing and calibration laboratories. 3rd ed. Geneva, Switzerland: International Organization for Standardization; 2017.
3. ISO 17034:2016. General requirements for the competence of reference material producers. 2nd ed. Geneva, Switzerland: International Organization for Standardization; 2016.
4. Ho K, Afssaps F. Control of biological. [online]. 2011; [cited 2021 Feb 8]; [29 screens]. Available from: URL: http://www.
5. Food and Drug Administration. Analytical procedures and methods validation for drugs and biologics: guidance for industry. [online]. 2015; [cited 2020 May 5]; [18 screens]. Available from: URL: https://www.fda.gov/media/87801/
6. International Conference on Harmonization (ICH). ICH Q2(R1) Validation of analytical procedures: text and methodology. [online]. 2005; [cited 2020 May 5]; [17 screens]. Available from: URL: https://www.gmp-compliance.org/files/
7. World Health Organization. Guidelines on validation – appendix 4: analytical method validation. [online]. 2016; [cited 2020 May 5]; [11 screens]. Available from: URL: https://www.
8. กฎกระทรวงแบ่งส่วนราชการกรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข พ.ศ. 2552. ราชกิจจานุเบกษา เล่ม 126 ตอนที่ 98 ก (วันที่ 28 ธันวาคม 2552). หน้า 70.