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  • Aaseptic and Process Report: FDA LACF Inspection Report

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    The document discusses the FDA approval process for new drugs in the United States. It outlines the various stages of clinical trials that a potential new drug must go through to be approved as safe and effective. It also describes the manufacturing and quality control information that must be submitted to the FDA regarding the composition, manufacturing process, and specifications for a new drug. The FDA approval process is designed to scientifically evaluate both the quality and performance of new drugs before they can be marketed and prescribed to patients in the US.

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    The document discusses the FDA approval process for new drugs in the United States. It outlines the various stages of clinical trials that a potential new drug must go through to be approved as safe and effective. It also describes the manufacturing and quality control information that must be submitted to the FDA regarding the composition, manufacturing process, and specifications for a new drug. The FDA approval process is designed to scientifically evaluate both the quality and performance of new drugs before they can be marketed and prescribed to patients in the US.

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    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
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    19 views4 pages

    Aaseptic and Process Report: FDA LACF Inspection Report

    Uploaded by

    gadde1987
    The document discusses the FDA approval process for new drugs in the United States. It outlines the various stages of clinical trials that a potential new drug must go through to be approved as safe and effective. It also describes the manufacturing and quality control information that must be submitted to the FDA regarding the composition, manufacturing process, and specifications for a new drug. The FDA approval process is designed to scientifically evaluate both the quality and performance of new drugs before they can be marketed and prescribed to patients in the US.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 4

    http://www.rxlist.com/script/main/art.asp?

    articlekey=113034
    http://commons.emich.edu/cgi/viewcontent.cgi?
    article=1014&context=theses&sei-
    redir=1#search="how+new+drugs+are+approved+in+us"

    http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryI
    nformation/Guidances/UCM070632.pdf
    http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation
    /Guidances/ucm122886.htm
    safety testing
    http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf

    aaseptic and process report

    http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM071562.pdf

    FDA LACF Inspection Report

    http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM071550.pdf 1.
    Intermediates and In-process Controls.
    • a. Pivotal intermediate
    • b. Key intermediate(s)
    • c. Final intermediate
    • 2. Reprocessing
    • F. Drug Substance Controls
    • 1. Sampling
    • 2. Release Controls
    • a. Appearance/description .
    • b. Physical properties
    • c. Specific identity test(s)
    • d. Impurity profile and limits
    • e. Assay
    • 3. Reference Standard .
    • G. Solid-State Drug Substance Forms: Relationship to
    Bioavailability
    • 1. Polymorphism
    • 2. Solvation (including hydration)
    • 3. Particle Size (and surface area)
    • III. REQUIREMENTS FOR AN INVESTIGATIONAL NEW
    DRUG (IND)
    • A. New Chemical Entity
    • 1. Phases 1 and 2
    • a. Physical and chemical characteristics
    • b. Manufacture of the new drug substance
    • c. Analytical methods
    • 2. Phase 3
    • a. Manufacture of the new drug substance
    • b. Analytical methods
    • B. Known Chemical Entity
    • 1. Sponsor-Investigator Research Study (documentation on file)
    • 2. Sponsor-Investigator Research Study or Commercial Sponsor (no
    documentation of file)
    • IV. CURRENT GOOD MANUFACTURING PRACTICE
    REQUIREMENTS
    • REQUIREMENTS FOR A NEW DRUG APPLICATION .
    • A. Physical and Chemical Characteristics
    • 1. Properties
    • 2. Structure
    • B. Stability
    • C. Name and Address of the Manufacturer
    • D. Manufacture of the Drug Substance
    • 1. Material Controls
    • a. Starting materials
    • (1) Definition of starting material
    • (2) Control procedures for starting materials
    • b. Reagents, solvents, and auxiliary materials controls
    • 2. Synthetic Drug Substance
    • a. Flow chart of the synthesis
    • b. Description of the synthesis
    • c. Purification of the drug substance
    • d. Changes in the synthesis
    • 3. Reference Standard
    • 4. In Situ Products (not isolated)
    • 5. Microencapsulation 6. Antibiotics and Other Drug
    Substances from Fermentation or Natural
    • Sources
    • a. Fermentation
    • (1) Control procedures for starting materials
    • (2) Microbial identification, source, deposition
    • (3) Fermentation process monitoring and control
    • b. Extraction, isolation, analysis, characterization
    • c. Drug substances obtained from plants and animals
    • (1) Plants (2) Animals
    • d. Semisynthetic antibiotics and other drug substances
    derived from
    • fermentation and natural sources
    • E. Process Controls
    •

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