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

Emma Ramnarine; Anders Vinther; Kimberly Bruhin; Christina Tovar; Marcello Colao

doi:10.5731/pdajpst.2020.011734

Article CommentaryCommentary

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

Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello Colao

PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734

Emma Ramnarine

1Genentech/Roche, 1 DNA Way, South San Francisco, CA 94539;

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For correspondence: eramnar@gene.com

Anders Vinther

2Intarcia Therapeutics, 24650 Industrial Boulevard, Hayward, CA 94545;

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Kimberly Bruhin

3Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933; ;

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For correspondence: kbruhin1@its.jnj.com

Christina Tovar

4Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933; and

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Marcello Colao

5GSK Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium

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vol. 74 no. 4 456-467

DOI

https://doi.org/10.5731/pdajpst.2020.011734

PubMed

32467177

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online July 31, 2020.

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previous version (May 28, 2020 - 09:03).
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Author Information

Emma Ramnarine¹,*,
Anders Vinther²,
Kimberly Bruhin³,
Christina Tovar⁴ and
Marcello Colao⁵

¹Genentech/Roche, 1 DNA Way, South San Francisco, CA 94539;
²Intarcia Therapeutics, 24650 Industrial Boulevard, Hayward, CA 94545;
³Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933; kbruhin1{at}its.jnj.com;
⁴Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933; and
⁵GSK Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium

↵*Corresponding Author: Genentech/Roche, 1 DNA Way, South San Francisco, CA 94539; Telephone: (650) 467-9616; E-mail: eramnar{at}gene.com

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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

Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar, Marcello Colao

PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 456-467; DOI: 10.5731/pdajpst.2020.011734

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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

Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar, Marcello Colao

PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 456-467; DOI: 10.5731/pdajpst.2020.011734

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Keywords

Pharmaceuticals
Post-approval change (PAC)
ICH Q10
Pharmaceutical quality system (PQS)
ICH Q12
science and risk-based approach

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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

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