Research ArticlePDA Papers
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), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575
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Emma Ramnarine
Genentech
Ursula Busse
Novartis
Marcello Colao
GlaxoSmithKline Biologicals
Julia Edwards
Biogen
Kevin O'Donnell
Health Products Regulatory Authority (HPRA), Ireland
Maik Jornitz
G-Con, LLC
Morten Munk
NNE Pharmaplan
Melissa Seymour
Biogen
Mihaela Simianu
Pharmatech Associates
Lisa Skeens
Pfizer
Anders Vinther
Sanofi-Pasteur
Reference
- 1.↵Quality Guideline Q10: Pharmaceutical Quality System; International Conference on Harmonisation: Geneva, Switzerland, 2008 [http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed August 28, 2016)].
- 2.↵PDA Points to Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities. PDA J. Pharm. Sci. Technol. (accepted article January 2017) [journal.pda.org (accessed January 23, 2017)].
- 3.↵Quality Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, concept paper and business plan; ICH: Geneva, 2014.
- Concept paper: [http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Final_Concept_Paper_July_2014.pdf (accessed December 2016)].
- Business plan: [http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Final_Buisness_Plan_July_2014.pdf (accessed December 2016)].
- 4.↵White Paper: FDA Pharmaceutical Quality Oversight, One Quality Voice; Office of Pharmaceutical Quality, U.S. Food and Drug Administration, U.S. Government Printing Office: Washington, DC, 2015 [http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM442666.pdf (accessed January 6, 2017)].
- 5.↵Final Report on Pharmaceutical cGMPs for the 21st Century—A Risk Based Approach; U.S. Food and Drug Administration, September, 2004 [http://www.fda.gov/downloads/drugs/developmentapprovalprocess/manufacturing/questionsandanswersoncurrentgoodmanufacturingpracticescgmpfordrugs/ucm176374.pdf (accessed January 23, 2017].
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 3
May/June 2017
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), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: 10.5731/pdajpst.2017.007575
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), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: 10.5731/pdajpst.2017.007575
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