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
Research ArticleTechnology/Application

Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma Suppliers

Carles Parés, Manuel Martínez, Joaquim Messeguer and Esteban Rodríguez
PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 620-630; DOI: https://doi.org/10.5731/pdajpst.2015.01074
Carles Parés
Suppliers Qualification Department, Grifols Biomat S.A.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: carles.pares@grifols.com
Manuel Martínez
Suppliers Qualification Department, Grifols Biomat S.A.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Joaquim Messeguer
Suppliers Qualification Department, Grifols Biomat S.A.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Esteban Rodríguez
Suppliers Qualification Department, Grifols Biomat S.A.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    European Commission. EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Annex 14: Manufacture of Medicinal Products derived from Human Blood or Plasma. Available at: http://ec.europa.eu/health/files/eudralex/vol-4/annex14_rev30-03_2011_en.pdf.
  2. 2.↵
    1. Padilla A
    . World Health Organization (WHO). GMP for Blood Establishments (GMP for plasma donations). Kuwait, November 2012. Available at: http://www.docstoc.com/docs/157769043/GMP-for-plasma-donations.
  3. 3.↵
    1. Wilson E. C. Jr..,
    2. Heyl M. S.
    As purchasing controls become an FDA hot topic, it's time to assess how well you are managing your supplier. J Medical Device Regul. 2009, 6, 24-39.
    OpenUrl
  4. 4.↵
    European Commission. EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. June 2012. Available at: http://www.ecv.de/leseproben/781807.pdf.
  5. 5.↵
    The European Medicines Agency: EMEA/CHMP/BWP/3794 Guideline on the scientific data requirements for a PMF. November 2006. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003663.pdf.
  6. 6.↵
    The European Medicines Agency: EMA/CHMP/BWP/548524/2008 Guideline on epidemiological data on blood transmissible infections. April 2010. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/10/WC500097728.pdf.
  7. 7.↵
    The European Medicines Agency: EMEA/CHMP/BWP/706271/2010 Guideline on plasma-derived medicinal products. July 2011. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/07/WC500109627.pdf.
  8. 8.↵
    European Pharmacopoeia Monograph: Human plasma for fractionation 01/2008:0853. January 2005. Available at: http://lib.njutcm.edu.cn/yaodian/ep/EP5.0/16_monographs/monographs_d-k/Human%20plasma%20for%20fractionation.pdf.
  9. 9.↵
    1. Seifried E.,
    2. Seidl C.
    European Blood Inspection System (EUBIS). Common European Standards and Criteria for the Inspection of Blood Establishments; Seifried E., Seidl C., Eds.; Edition 1.0; EUBIS: Frankfurt, Germany; 2010. Available at: http://www.eubis-europe.eu/_pdf/DINA5_EUBIS_Part_A_Guidelines_Edition_01_FN-7.pdf.
  10. 10.↵
    Commission Directive of the European Parliament & Council of EU: 2005/61/EC implementing Directive 2002/98/EC as regards traceability requirements and notification of serious adverse reactions and events. September 2005. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32005L0061&qid=1427186769119&from=EN.
  11. 11.↵
    Commission Directive of the European Parliament & Council of EU: 2005/62/EC implementing Directive 2002/98/EC as regards community standards and specifications relating to a quality system for blood establishments. September 2005. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32005L0062&qid=1427186961998&from=EN.
  12. 12.↵
    Commission Directive of the European Parliament & Council of EU: 2004/33/EC implementing Directive 2002/98/EC as regards certain technical requirements for blood and blood components. March 2004. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004L0033&qid=1427187032106&from=EN.
  13. 13.↵
    1. Mubangizi D. K.
    World Health Organization (WHO). WHO, GMP, & API Inspections. Beijing, March 2010. Available at: http://apps.who.int/prequal/trainingresources/pq_pres/workshop_China-API_March2010/29-PM/1-PQP_Inspections_ENG.ppt.
  14. 14.↵
    World Health Organization (WHO). Annex 4. Recommendations for the production, control and regulation of human plasma for fractionation. 2011. Available at: http://www.who.int/bloodproducts/publications/GMP_Bloodestablishments.pdf.
  15. 15.↵
    Directive European Parliament & Council of EU: 2002/98/EC setting, standards, of quality of safety for collection, testing, processing, storage, and distribution of human blood and blood components. January 2003. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2002_98/dir_2002_98_en.pdf.
  16. 16.↵
    Directive European Parliament & Council of EU: 2001/83/EC Community code relating to medical products for human use. November 2001. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf.
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 69 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 5
September/October 2015
  • Table of Contents
  • Index by Author
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.
Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma Suppliers
(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.
4 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma Suppliers
Carles Parés, Manuel Martínez, Joaquim Messeguer, Esteban Rodríguez
PDA Journal of Pharmaceutical Science and Technology Sep 2015, 69 (5) 620-630; DOI: 10.5731/pdajpst.2015.01074

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma Suppliers
Carles Parés, Manuel Martínez, Joaquim Messeguer, Esteban Rodríguez
PDA Journal of Pharmaceutical Science and Technology Sep 2015, 69 (5) 620-630; DOI: 10.5731/pdajpst.2015.01074
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • 1. Introduction
    • 2. Plasma Suppliers and Services Qualification
    • 3. Initial Qualification
    • 4. Continuous Qualification
    • 5. Industry Experience: Results of Grifols' Evaluation
    • 6. Conclusions
    • Conflict of Interest Declaration
    • Acknowledgements
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Show more Technology/Application

Similar Articles

Keywords

  • Grifols
  • Plasma supplier qualification
  • Industry experience
  • Plasma quality
  • Plasma safety

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

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire