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Resources: Document

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  1. Analytical Procedure Development

    Guideline provides a foundation for consistent development of analytical methods to maintain precision and accuracy, contirubting to the maintenance of quality products.

  2. Analytical Validation

    Guideline establishes the requirements for validationg analytical methods, ensuring consistency in the routeine measurements of pharmaceutical products and their intermediates.

  3. Continuous Manufacturing of Drug Substances and Drug Products

    Guideline gives information and requirements for the production of API in pharmaceutical continuous manufactring processes.

  4. Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

    Guideline establishes reuqirements for the synthesis/production of API in primary pharmaceutical manufacturing.

  5. Effective Development of PAT Capability in Pharmaceutical Manufacturing

    Contributor(s): Hammond, Steve

    Over the last ten years, the path to effective development of PAT has evolved, driven by the advent of continuous manufacturing. The development and deployment of PAT used for pharmaceutical manufacturing has arrived at a point where application development has been miniaturized and streamlined....

  6. Electric Common Technical Document

    This work establishes the requirements and guidelines for submitting an eCTD to ensure consistency in applications.

  7. Good Manufacturing Practice Guide for Active Pharmacetuical Ingredients

    Guideline highlgihts important aspects of manufacturing API.

  8. Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

    This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has...

  9. Light Diffraction Measurement of Particle Size

    Standard explain phenomena associated with light interaction with powder.

  10. Monitoring Devices - Time, Temperature, Humidity

    Standard explains intricacies associated with various monitoring tools for use in process monitoring settings.