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Table representation of search results timeline featuring number of search results per year.

Year Number of Results
1800 4
1801 1
1982 1
1995 1
1996 1
2002 1
2006 1
2008 1
2009 4
2010 5
2011 9
2012 5
2013 9
2014 10
2015 17
2016 13
2017 11
2018 8
2019 8
2020 10
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Similar Articles for PMID: 32675306

107 results
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Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer can help close the Q10 to Q12 Gap.
Lipa MJ, Greene A, Calnan N. Lipa MJ, et al. PDA J Pharm Sci Technol. 2020 Jul 16:pdajpst.2020.011825. doi: 10.5731/pdajpst.2020.011825. Online ahead of print. PDA J Pharm Sci Technol. 2020. PMID: 32675306
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
ISO 9001:2015 vs ICH Q10 - A Comparison.
Aaberg C, Dahmen H, Davies C, Sandau PL, Srinivasan R. Aaberg C, et al. PDA J Pharm Sci Technol. 2020 Sep 30:pdajpst.2020.011692. doi: 10.5731/pdajpst.2020.011692. Online ahead of print. PDA J Pharm Sci Technol. 2020. PMID: 32999074
Quality Risk Management Competency Model-Case for the Need for QRM Competencies.
Haddad G, Greene A. Haddad G, et al. PDA J Pharm Sci Technol. 2019 Jul-Aug;73(4):331-344. doi: 10.5731/pdajpst.2019.009944. Epub 2019 May 17. PDA J Pharm Sci Technol. 2019. PMID: 31101709
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
[Pharmaceutical product quality control and good manufacturing practices].
Hiyama Y. Hiyama Y. Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2010;(128):1-16. Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2010. PMID: 21381389 Japanese.
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
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
Raw materials in the manufacture of biotechnology products: regulatory considerations.
Cordoba-Rodriguez R. Cordoba-Rodriguez R. PDA J Pharm Sci Technol. 2010 Sep-Oct;64(5):445-50. PDA J Pharm Sci Technol. 2010. PMID: 21502051
PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.
Krause SO. Krause SO. PDA J Pharm Sci Technol. 2015 Sep-Oct;69(5):569-89. doi: 10.5731/pdajpst.2015.01065. PDA J Pharm Sci Technol. 2015. PMID: 26429107 Review.
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