Similar articles for PMID: 32179712

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1

Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System.

Rolke R, Ramnarine E, Vinther A, Sawant A. Rolke R, et al. PDA J Pharm Sci Technol. 2020 Mar-Apr;74(2):286-288. doi: 10.5731/pdajpst.2019.011239. Epub 2020 Mar 16. PDA J Pharm Sci Technol. 2020. PMID: 32179712 Review.

2

Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management.

Vinther A, Ramnarine E. Vinther A, et al. PDA J Pharm Sci Technol. 2019 Sep-Oct;73(5):517-521. doi: 10.5731/pdajpst.2019.010827. Epub 2019 Aug 16. PDA J Pharm Sci Technol. 2019. PMID: 31420505

3

Advanced qualification of pharmaceutical excipient suppliers by multiple analytics and multivariate analysis combined.

Hertrampf A, Müller H, Menezes JC, Herdling T. Hertrampf A, et al. Int J Pharm. 2015 Nov 10;495(1):447-458. doi: 10.1016/j.ijpharm.2015.08.098. Epub 2015 Sep 2. Int J Pharm. 2015. PMID: 26342249

4

Enabling ICH Q10 Implementation--Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9.

Calnan N, O'Donnell K, Greene A. Calnan N, et al. PDA J Pharm Sci Technol. 2013 Nov-Dec;67(6):581-600. doi: 10.5731/pdajpst.2013.00940. PDA J Pharm Sci Technol. 2013. PMID: 24265300

5

Vendor qualification for pharmaceutical excipients--GMP requirements and approach.

Patel KT, Chotal NP. Patel KT, et al. Pharmazie. 2010 Nov;65(11):783-90. Pharmazie. 2010. PMID: 21155382 Review.

6

An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment.

Boetzel R, Ceszlak A, Day C, Drumm P, Gil Bejar J, Glennon J, Harris L, Heghes CI, Horga R, Jacobs PL, Keurentjes WJTM, King F, Lee CW, Lewen N, Marchant CA, Maris FA, Nye W, Powell S, Rockstroh H, Rutter L, Schweitzer M, Shannon E, Smallshaw L, Teasdale A, Thompson S, Wilkinson D. Boetzel R, et al. J Pharm Sci. 2018 Sep;107(9):2335-2340. doi: 10.1016/j.xphs.2018.04.009. Epub 2018 Apr 18. J Pharm Sci. 2018. PMID: 29679706 Free article.

7

Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)-through Enhanced Science and Risk-Based Approaches.

Ramnarine E, Vinther A, Bruhin K, Tovar C, Colao M. Ramnarine E, et al. PDA J Pharm Sci Technol. 2020 Jul-Aug;74(4):456-467. doi: 10.5731/pdajpst.2020.011734. Epub 2020 May 28. PDA J Pharm Sci Technol. 2020. PMID: 32467177

8

Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm.

Van Buskirk GA, Asotra S, Balducci C, Basu P, DiDonato G, Dorantes A, Eickhoff WM, Ghosh T, González MA, Henry T, Howard M, Kamm J, Laurenz S, MacKenzie R, Mannion R, Noonan PK, Ocheltree T, Pai U, Poska RP, Putnam ML, Raghavan RR, Ruegger C, Sánchez E, Shah VP, Shao ZJ, Somma R, Tammara V, Thombre AG, Thompson B, Timko RJ, Upadrashta S, Vaithiyalingam S; Manufacturing Technical Committee of the Product Quality Research Institute. Van Buskirk GA, et al. AAPS PharmSciTech. 2014 Jun;15(3):665-93. doi: 10.1208/s12249-014-0087-x. Epub 2014 Mar 1. AAPS PharmSciTech. 2014. PMID: 24578237 Free PMC article. Review.

9

Industry One-Voice-of-Quality Solutions Management Review of Post-Approval Changes Guide.

Vinther A, Mohammed F, Ramnarine E. Vinther A, et al. PDA J Pharm Sci Technol. 2021 Sep-Oct;75(5):454-457. doi: 10.5731/pdajpst.2021.012627. Epub 2021 Mar 15. PDA J Pharm Sci Technol. 2021. PMID: 33723006

10

International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.

Food and Drug Administration, HHS. Food and Drug Administration, HHS. Fed Regist. 2009 Apr 8;74(66):15990-1. Fed Regist. 2009. PMID: 19507321 Free article.

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