CORE D The proposed projects (I, II, and III) all require the production of injectable substances for treatment diagnosis in human subjects. To ensure that these materials are safe, effective, and pure; an effective quality assurance and quality control program is required by federal regulations and must be instituted. We request personnel and supplies as a core support for the following: 1. Analysis of raw materials, intermediate products, and final products for identity, stability and purity as required by the Good Manufacturing Practices (GMP) sections of the Code of Federal Regulation Analyses include identity verification, sterility, bioburden assessment, endotoxin contamination , mycoplasma contamination, flow cytometry analysis, and potency testing. Review analyses and production records to assess the suitability of each production lot for human clinical trials. 2. Microbiological monitoring of the production facilities to ensure that cleaning, sanitization, and air quality systems are operating effectively. 3. Perform process validation and equipment certification and calibration to ensure that production processes are under control and operate reliable. 4. Provide documentation support, including the writing, reviewing, and control of investigation New Drug Applications (IND), Master and Production Batch Records, Standard Operating Procedures, Specification Analytical Procedures, Labeling, and Validation Reports.
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