Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Article CommentaryCommentary

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

Richard Rolke, Emma Ramnarine, Anders Vinther and Anil Sawant
PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239
Richard Rolke
1Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Lansdale, PA, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Emma Ramnarine
2Genentech/Roche, South San Francisco, CA, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: eramnar@gene.com
Anders Vinther
3Intarcia Therapeutics, Hayward, CA, USA; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Anil Sawant
4Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    International Conference for Harmonization, Quality Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. ICH: Geneva, 2019. https://www.ich.org/page/quality-guidelines (accessed Aug 15, 2019).
  2. 2.↵
    International Conference for Harmonization, Quality Guideline Q10: Pharmaceutical Quality System. ICH: Geneva, 2010. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed Aug 15, 2019).
  3. 3.↵
    International Conference for Harmonization, Quality Guideline Q9: Quality Risk Management. ICH: Geneva, 2006. http://www.ich.org/products/guidelines (accessed Aug 15, 2019).
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 74 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 2
March/April 2020
  • Table of Contents
  • Index by Author
  • Complete Issue (PDF)
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
5 + 15 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
Richard Rolke, Emma Ramnarine, Anders Vinther, Anil Sawant
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 286-288; DOI: 10.5731/pdajpst.2019.011239

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
Richard Rolke, Emma Ramnarine, Anders Vinther, Anil Sawant
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 286-288; DOI: 10.5731/pdajpst.2019.011239
del.icio.us logo Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Problem Statement
    • Context
    • Industry's Position
    • Conflict of Interest Declaration
    • Footnotes
    • References
  • Info & Metrics
  • References
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • Survey Report on Complaints Related to the Interconnectivity between Vial Containers and Transfer Devices
  • Enhancement of Cell-Based Vaccine Manufacturing through Process Intensification
  • Principles for Management of Extractables and Leachables in Ophthalmic Drug Products
Show more Commentary

Similar Articles

Keywords

  • Regulatory
  • Chemistry, Manufacturing and Controls (CMC)
  • International Conference for Harmonisation (ICH) Q10
  • Pharmaceutical quality system (PQS)
  • Post-approval change (PAC)
  • Excipient supplier name changes
  • Risk Implementation
  • Quality risk management
  • Regulatory relief

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2022 PDA Journal of Pharmaceutical Science and Technology ISSN: 1079-7440

Powered by HighWire