Similar articles for PMID: 29669814

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1

Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction.

Ramnarine E, O'Donnell K. Ramnarine E, et al. PDA J Pharm Sci Technol. 2018 May-Jun;72(3):338-345. doi: 10.5731/pdajpst.2017.008524. Epub 2018 Apr 18. PDA J Pharm Sci Technol. 2018. PMID: 29669814

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

PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes.

Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Ramnarine E, Busse U, Colao M, Edwards J, O'Donnell K, Jornitz M, Munk M, Seymour M, Simianu M, Skeens L, Vinther A. Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), et al. PDA J Pharm Sci Technol. 2017 May-Jun;71(3):252-258. doi: 10.5731/pdajpst.2017.007575. Epub 2017 Feb 14. PDA J Pharm Sci Technol. 2017. PMID: 28196929 Review. No abstract available.

4

A practical discussion of risk management for manufacturing of pharmaceutical products.

Mollah AH, Baseman HS, Long M, Rathore AS. Mollah AH, et al. PDA J Pharm Sci Technol. 2014 May-Jun;68(3):271-80. doi: 10.5731/pdajpst.2014.00975. PDA J Pharm Sci Technol. 2014. PMID: 25188348 Review.

5

A practical approach to supplier quality improvement.

O'Riordan L. O'Riordan L. J Parenter Sci Technol. 1991 Jan-Feb;45(1):29-40. J Parenter Sci Technol. 1991. PMID: 2007967

6

Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality.

O'Connor TF, Yu LX, Lee SL. O'Connor TF, et al. Int J Pharm. 2016 Jul 25;509(1-2):492-498. doi: 10.1016/j.ijpharm.2016.05.058. Epub 2016 May 31. Int J Pharm. 2016. PMID: 27260134 Review.

7

Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

Myerson AS, Krumme M, Nasr M, Thomas H, Braatz RD. Myerson AS, et al. J Pharm Sci. 2015 Mar;104(3):832-9. doi: 10.1002/jps.24311. Epub 2014 Dec 26. J Pharm Sci. 2015. PMID: 25546650 Review.

8

[Chinese medicine industry 4.0：advancing digital pharmaceutical manufacture toward intelligent pharmaceutical manufacture].

Cheng YY, Qu HB, Zhang BL. Cheng YY, et al. Zhongguo Zhong Yao Za Zhi. 2016 Jan;41(1):1-5. doi: 10.4268/cjcmm20160101. Zhongguo Zhong Yao Za Zhi. 2016. PMID: 28845630 Chinese.

9

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

10

[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.

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