Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

Issue link: https://www.e-digitaleditions.com/i/1171020

Contents of this Issue

Navigation

Page 21 of 54

22 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m for industry for the use of risk-based approaches for driving method validation activities such as precision studies. ICH Q14 will also provide the opportunity to define how performance criteria for method characteristics like precision should be created using concepts such as the analytical target profile (14,23,29). References 1. ICH, Q2(R1) Validation of Analytical Procedures: Text and Meth- odology (1994). 2. P. Nethercote, et al., Pharmaceutical Manufacturing 9 (4) (2010). 3. J. Ermer, J.H.M. Miller, Method Validation in Pharmaceutical Analysis, 1 ed.2005. 4. S. Kojima, Pharm. Tech. Japan 18 (5) 695–704 (2002). 5. N. Kaniwa and Y. Ojima, Pharm. Tech. Japan 1 (1) 171–179 (2000). 6. R. Ficarra, et al., J. Pharmaceut. Biomed. 23 (1) 169–174 (2000). 7. C. Ye, et. al., J. Pharmaceut. Biomed. 23 (2–3) 581–589 (2000). 8. J.O. De Beer, et al., J. Pharmaceut. Biomed. 32 (4–5) 767–811 (2003). 9. ICH Q8(R2) Pharmaceutical Development (2009). 10. ICH, Q9 Quality Risk Management (2005). 11. ICH Q10 Pharmaceutical Quality System (2008). 12. ICH Q11 Development and Manufacture of Drug Substances (2012). 13. P. Borman, et al., Pharm. Tech. 31 (10) 142–152 (2007). 14. M. Schweitzer, et al., Pharm. Tech. 34 (2) 52–59 (2010). 15. P.J. Borman, et al., Anal. Chim. Acta 703 (2) 101–113 (2011). 16. P.J. Borman, et al., J. Pharmaceut. Biomed. 48 (4) 1082–1089 (2008). 17. Joint Committee for Guides in Metrology, International Vocabu- lary of Metrology—Basic and General Concepts and Associated Terms (VIM) Section 2.22, 2012. 18. Joint Committee for Guides in Metrology, International Vocabu- lary of Metrology—Basic and General Concepts and Associated Terms (VIM) Section 2.20, 2012. 19. Phenomenex, SPE Method Validation Terms: Precision and Accuracy, SPE Method Validation Terms: Precision and Accuracy, 2016. 20. LC-MS Method Validation, 4.1. Repeatability, intermediate pre- cision and reproducibility, University of Tartu, https://sisu.ut.ee/ lcms_method_validation/41-precision-trueness-accuracy 21. R. Boqué, et al., Grasas y Aceites 53 (1) 128–143 (2002). 22. ECA Academy 2001, Validation of Analytical Methods: Interme- diate Precision (2001). 23. P. Jackson, et al., Anal. Chem. 91 (4) 2577–2585 (2019). 24. V.A. Marple, et al., J. Aerosol Med. 16 (3) 283–299 (2003). 25. European Pharmacopeia, 9.0, 2.9.18. Preparations for Inha- lation, Figure 2.9.18.-11, Page 332. 26. European Pharmacopeia, 9.0, 2.9.18. Preparations for Inhalation, Figure 2.9.18.-12, Page 333. 27. ICH, ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation, Final Concept Paper (2018). 28. A. Teasdale, et al., Org. Process Res. Dev. 22 (12) 1712–1715 (2018). 29. A. Rignall, et al., Pharm. Tech. Eur. 30 (12) 10–16 (2018). 30. J. Ermer, J. Pharmaceut. Biomed. 160 73–79 (2018). 31. M.E. Popkin, et al., J. Pharm. Innov. 13 (4) 367–372 (2018). 32. M.E. Popkin, et al., J. Pharm. Innov. 14 (2) 176–184 (2019). PT Call for Peer-Review Papers Pharmaceutical Technology and Pharmaceutical Technology Europe magazines set the standard for publishing independent, industry-leading information on the technologies, strategies, and regulations crucial to professionals developing and manufacturing pharmaceuticals and biopharmaceuticals. The editorial mix of peer-reviewed papers, technical articles, technology reports, regulatory and business columns, and expert commentary provide comprehensive coverage of process and formulation development, manufacturing operations, drug delivery, packaging, labeling, and distribution. Peer-review papers are a vital part of Pharmaceutical Technology's coverage of scientific and technical advances in bio/pharmaceutical development and manufacturing. Four types of peer-review papers are considered: standard data-driven, novel research; topical literature or patent review; technical case studies/technical application notes; and science-based opinion papers. Manuscripts for peer-review papers are accepted on an ongoing basis. Publication priority is given to papers in the order they are accepted for publication. Submitted papers undergo formal review by a member of the editorial advisory board, who will review the article for technical interest and content in a double-blind review process. The review, revision, and acceptance process typically takes six to eight weeks. Important guidelines to note prior to submitting a peer-review paper include the following: • The article/paper must be objective and cannot promote a company or its products. All performance-related claims must be supported by references to published literature. • The article/paper must be original and submitted to Pharmaceutical Technology/Pharmaceutical Technology Europe on an exclusive basis. • The article/paper cannot have been published previously in any format, including a company website or marketing literature. • Manuscripts are reviewed with the understanding that they are not ghostwritten and are not under consideration for publication elsewhere, including on the Internet. • Submission of an article/paper is not a guarantee of publication. The decision to publish is based on editorial review, advisory board review for peer-review papers, scheduling, and available space in the print issue. • All authors are required to sign a license agreement that provides Pharmaceutical Technology permission to publish the original article and its associated figures/tables in print and online. To learn more, visit www.PharmTech.com/pharmtech-submission- guidelines-and-editorial-calendars. Analytical Procedure Validation

Articles in this issue

Links on this page

Archives of this issue

view archives of Pharmaceutical Technology - September 2019 - Pharmaceutical Technology - Regulatory Sourcebook