Data integrity within the biopharmaceutical sector in the era of Industry 4.0-Reference-Cited by-同舟云学术

Data integrity within the biopharmaceutical sector in the era of Industry 4.0

Published:2022-04-07 Issue:6 Volume:17 Page:2100609
ISSN:1860-6768
Container-title:Biotechnology Journal
language:en
Short-container-title:Biotechnology Journal

Author:

Alosert Haneen¹^ORCID,Savery James²,Rheaume Jennifer³,Cheeks Matthew⁴,Turner Richard⁵,Spencer Christopher⁴,S. Farid Suzanne¹^ORCID,Goldrick Stephen¹^ORCID

Affiliation:

1. The Advanced Centre of Biochemical Engineering Department of Biochemical Engineering University College London London UK

2. Bioprocess Development Data Science & Modelling AstraZeneca Cambridge UK

3. Equipment and Software Validation Development Quality Biologics AstraZeneca Gaithersburg Maryland USA

4. Cell Culture Fermentation Sciences Biopharmaceuticals Development R&D AstraZeneca Cambridge UK

5. Purification Process Sciences Biopharmaceuticals Development R&D AstraZeneca Cambridge UK

Publisher

Wiley

Subject

Molecular Medicine,Applied Microbiology and Biotechnology,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/biot.202100609

Reference29 articles.

1. FDA. (2018 August 10).Warning letter Kyowa Hakko Bio Co. Ltd. U.S. FOOD & DRUG ADMINISTRATION.https://www.fda.gov/inspections‐compliance‐enforcement‐and‐criminal‐investigations/warning‐letters/kyowa‐hakko‐bio‐co‐ltd‐543924‐08102018

2. Industry 4.0: a vision for personalized medicine supply chains?

3. Data science tools and applications on the way to Pharma 4.0

4. FDA. (2018).Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry(Issue December).https://www.fda.gov/media/119267/download

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