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Article CommentaryCommentary Special Section

A Review of the Aging Process and Facilities Topic

Maik W. Jornitz
PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 553-556; DOI: https://doi.org/10.5731/pdajpst.2015.01061
Maik W. Jornitz
G-CON Manufacturing, Inc., 8800 HSC Pkwy, Bryan, Texas 77807
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References

  1. 1.↵
    1. Woodcock J.,
    2. Wosinska M.
    Economic and technological drivers of generic sterile injectable drug shortages. Clin. Pharm. Ther. 2013, 93 (2), 170–176.
    OpenUrlPubMed
  2. 2.↵
    1. Bohn E.,
    2. Nogalski Krapf M.
    Master Planning Legacy Facilities: Dealing with the Issues of a “Band-Aid” Approach. International Society of Pharmaceutical Engineering ISPEAK, 2014.
  3. 3.↵
    1. Miller G.
    Ben Venue inspection yields 48 GMP violations. Fierce Pharma Manufacturing Oct, 19th, 2011.
  4. 4.↵
    1. Struck K.
    Quality control costs tied to drug shortages. Med Page Today Jan. 23rd, 2013.
  5. 5.↵
    1. Crowe M.
    Enterprise Benefits of Quality Systems. PDA/FDA Conference, Washington, DC, Sept. 9th, 2014.
  6. 6.↵
    1. Jornitz M. W.
    Flexible facilities of the future—examples. 2014 PDA Europe Conference Modern Biopharmaceutical Manufacturing, Manufacturing of the Future 25 - 26 March 2014, Lyon, France.
  7. 7.↵
    1. Vinther A.
    Expediting Post Approval Regulatory Changes to Mitigate Drug Shortages. PDA Drug Shortage Workshop, Washington, DC, Sept. 8th, 2014.
  8. 8.↵
    Product Quality Research Institute (PQRI). Post Approval Changes for Sterile Products Working Group, April 19th, 2007.
  9. 9.↵
    International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Award, Med Immune Equipment Innovation Award. ISPE, Tampa, FL, Nov. 7th, 2013.
  10. 10.↵
    1. Tschumakow A.
    Single Use Systems—An End User's Perspective. IBC 2nd Annual Flexible Facilities Conference, Claremont, CA, Feb. 24th, 2014.
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PDA Journal of Pharmaceutical Science and Technology: 69 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 4
July/August 2015
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A Review of the Aging Process and Facilities Topic
Maik W. Jornitz
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 553-556; DOI: 10.5731/pdajpst.2015.01061

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A Review of the Aging Process and Facilities Topic
Maik W. Jornitz
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 553-556; DOI: 10.5731/pdajpst.2015.01061
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Keywords

  • Aging facility
  • Drug shortage
  • Single-use technology
  • Modular facilities
  • Post-approval changes

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