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

Richard Rolke; Emma Ramnarine; Anders Vinther; Anil Sawant

doi:10.5731/pdajpst.2019.011239

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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;

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Emma Ramnarine

2Genentech/Roche, South San Francisco, CA, USA;

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For correspondence: eramnar@gene.com

Anders Vinther

3Intarcia Therapeutics, Hayward, CA, USA; and

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Anil Sawant

4Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA

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References

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.↵
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.↵
International Conference for Harmonization, Quality Guideline Q9: Quality Risk Management. ICH: Geneva, 2006. http://www.ich.org/products/guidelines (accessed Aug 15, 2019).

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PDA Journal of Pharmaceutical Science and Technology

Vol. 74, Issue 2

March/April 2020

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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

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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

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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

[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).

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