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  1. NLM Digital Collections - COVID-19 : continued attention needed to enhance federal preparedness, response, service ... 
    Publication: Washington, DC : United States Government Accountability Office, July 2021
    resource.nlm.nih.gov/9918317487806676
    ... laboratory testing. However, the agency did not have manufacturing contracts in place prior to the COVID-19 pandemic ... 28, 2020.124 However, CDC did not have manufacturing contracts in place prior to the pandemic that could ...
  2. NLM Digital Collections - Letter from Walter Treadway to Lawrence Kolb 
    Publication: Produced: 16 September 1935
    resource.nlm.nih.gov/9918351284206676X210
    ... at Ft. Leavenworth, KS, and about possible garment-manufacturing contracts. ... at Ft. Leavenworth, KS, and about possible garment-manufacturing contracts. Produced: 16 September 1935 Treadway, Walter L. (Walter ...
  3. NLM Digital Collections - Q7 good manufacturing practice guidance for active pharmaceutical ingredients : questions and ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
    resource.nlm.nih.gov/101734165
    ... activities performed. Given the potential complexity of outsourcing contract manufacturing arrangements, GMP responsibilities should be clearly defined between ...
  4. NLM Digital Collections - COVID-19. Agencies are taking steps to improve future use of Defense Production Act ... 
    Publication: Washington, DC : United States Government Accountability Office, December 2021
    resource.nlm.nih.gov/9918383085406676
    ... example, agencies placed priority ratings on six vaccine manufacturing contracts and additional ratings for monoclonal antibody therapeutics, which ...
  5. NLM Digital Collections - Mixing, diluting, or repackaging biological products outside the scope of an approved ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
    resource.nlm.nih.gov/101720078
    ... 211.22(a). See also guidance for industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements. We recommend that ...
  6. NLM Digital Collections - Regulatory considerations for human cells, tissues, and cellular and tissue-based products : .... 
    Publication: Silver Spring, MD : Center for Devices and Radiological Health, December 2017
    resource.nlm.nih.gov/101719954
    ... HCT/Ps; and 2) Facilities that engage in contract manufacturing services for a manufacturer of HCT/Ps (21 ...
  7. NLM Digital Collections - Business of healthcare 
    Publication: [Toronto, Ontario] : Thomson Reuters, 23-December-2019
    resource.nlm.nih.gov/101762183
    ... on Tuesday after it agreed to sell its contract manufacturing unit to reduce [FN30] debt and its chief ...
  8. pdf1967-68.pdf 
    https://www.nlm.nih.gov/.../nlmarchives/annualreport/1967-68.pdf
    ... been filmed. One of the major causes of contract delay was manufacturing and process- ing problems with direct duplicating film, ...
  9. NLM Digital Collections - Q12 technical and regulatory considerations for pharmaceutical product lifecycle management 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
    resource.nlm.nih.gov/9918350987306676
    ... MAHs, research and development (R&D) organizations, manufacturers, Contract Manufacturing Organizations (CMOs), suppliers). It is important that these ...
  10. NLM Digital Collections - Biological product deviation reporting for blood and plasma establishments 
    Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, March 2020
    resource.nlm.nih.gov/101772639
    ... CFR 606.171(a), we do not consider contract manufacturing to include the supply of blood products to ... i.e., it was not irradiated under a contract manufacturing agreement. 4. EVENT You are a transfusion service ...
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