- 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. ...
- 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 ...
- NLM Digital Collections - Snapshots of recent state initiatives in Medicaid prescription drug cost controlPublication: 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 ...
- 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 ...
- 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 ...
- NLM Digital Collections - Remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities ...Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, April 2021... of manufacturing operations. Surveillance inspections are performed at active pharmaceutical ingredient and drug product manufacturing facilities, as well as outsourcing facilities that have ...
- 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). ... Pharmaceutical Quality System (April 2009), and Q7 Good Manufacturing Practice ... Ingredients (September 2016). Silver Spring, MD : Center for Drug ...
- NLM Digital Collections - Cover letter attachments for controlled correspondence and ANDA submissions : guidance for ...Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023... statement) Exclusivity Dosage Form Patent or Pharm/Tox Manufacturing: Exclusivity Facility Active Pharmaceutical Ingredient (API) Finished Dosage Form (FDF) (including packaging and ...
- NLM Digital Collections - Comparability Protocols for postapproval changes to the chemistry, manufacturing, and ...Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022... CGMP, see ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (September 2016) (ICH Q7). For recommendations regarding an ...
- 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: ...
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