Measurement uncertainty in testing of biologicals in national control laboratories for ISO/IEC 17025: practical approaches-Reference-Cited by-同舟云学术

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Measurement uncertainty in testing of biologicals in national control laboratories for ISO/IEC 17025: practical approaches

Published:2024-04-14 Issue:3 Volume:29 Page:253-261
ISSN:0949-1775
Container-title:Accreditation and Quality Assurance
language:en
Short-container-title:Accred Qual Assur

Author:

Tewari Shalini,Trivedi Niharika,Goel Sanchi,Shrivastava Rashmi,Gopinath Sudha V.,Khurana Ayushi,Anvikar Anupkumar R.

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1007/s00769-024-01589-8.pdf

Reference18 articles.

1. Food and Drug Administration Office of Regulatory Affairs ORA Laboratory Manual Volume II Document Number: ORA-LAB.5.4.6 Revision #: 02 Revised: 05/15/2019 Title: Estimation of Measurement Uncertainty

2. General European OMCL Network (GEON) Quality Management Document PA/PH/OMCL (18) 145 R1 CORR Evaluation of Measurement Uncertainty Core Document (1 February 2020)

3. WHO Good practices for pharmaceutical quality control laboratories. In: WHO Expert committee on specifications for pharmaceutical preparations, Forty-fourth report. Geneva: WHO; 2010: Annex 1 (WHO Technical Report Series 957)

4. Model Certificate of Analysis In: WHO Expert committee on specifications for pharmaceutical preparations, Fifty-second report. Geneva: WHO; 2018: Annex 4 (WHO Technical Report Series 1010)

5. India Pharmacopoeia 2022, General Notices

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