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1,238 results
  1. 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
    ... guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. ...
  2. NLM Digital Collections - Snapshots of recent state initiatives in Medicaid prescription drug cost control 
    Publication: Menlo Park, CA : Henry J. Kaiser Family Foundation, February 2018
    ... drug manufacturers also point to supply problems in active pharmaceutical ingredients; manufacturing challenges for certain drugs such as narcotics or ...
  3. NLM Digital Collections - Drug safety : FDA should take additional steps to improve its foreign inspection program : ... 
    Publication: Washington, DC : United States Government Accountability Office, January 2022
    ... Drug Drugs sold in the United States-including active pharmaceutical Manufacturing ingredients and finished dosage forms-are manufactured throughout the ...
  4. NLM Digital Collections - Importation of certain FDA approved human prescription drugs, including biological products, .... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
    ... product, as well as the entirety of the manufacturing process, from active pharmaceutical ingredient through finished product, meets all of the specifications ...
  5. NLM Digital Collections - CMC postapproval manufacturing changes for specified biological products to be documented in .... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2021
    ... Pharmaceutical Quality System (April 2009), and Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (September 2016). The contents of this document do ...
  6. NLM Digital Collections - Drug safety : preliminary findings indicate persistent challenges with FDA foreign ... 
    Publication: Washington, DC : United States Government Accountability Office, December 10, 2019
    ... Drug Drugs sold in the United States—including active pharmaceutical Manufacturing ingredients and finished dosage forms—are manufactured throughout the ...
  7. NLM Digital Collections - Control of nitrosamine impurities in human drugs 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, February 2021
    ... and the ICH guidances for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (September 2016) and Q11 Development and Manufacture of ...
  8. NLM Digital Collections - Good manufacturing practice considerations for responding to COVID-19 infection in employees .... 
    Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, June 2020
    ... API), the ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (September 2016), section III., Personnel (3), 10 recommends: ...
  9. NLM Digital Collections - Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol, including during .... 
    Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021
    ... 17) of FDA’s guidance for industry Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7A). We update guidances periodically. To make sure ...
  10. NLM Digital Collections - Development and submission of near infrared analytical procedures 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2021
    ... with the ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (September 2016) recommendations for drug substances. This guidance ...
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