Writing Detailed Process Descriptions Package

This SOP package features a procedure that provides comprehensive instructions on creating Detailed Process Descriptions, which provide the most up-to-date information on equipment, materials, methods, process steps, and unit operations, as well as specifications for raw materials and components, intermediates, bulk drug substances, and drug product. The procedure also includes appropriate example tables to provide further guidance on creating the document.

This package includes:

  

• Specific instructions for creating Detailed Process Descriptions, in a fully editable Microsoft Word document, which can be easily integrated into any documentation system and used in any technology transfer situation. This package can also be used to create a Process Specification Document for a cGMP campaign.
• An Adobe PDF document of all native files to serve as a permanent record of the original package contents.

Topics covered in this Package include:

• Summary of the Active Component
• Materials, Components, and Equipment
• Process Information
• Analytical Information
• In-Process and Lot Release Testing
• Representative Runs
• References

Below are screenshots of 2 of the 9 pages:

   



With this KymaSTORE purchase, you will also receive a 30 minute conference call with a Kymanox Subject Matter Expert and complimentary package updates for 6 months from the original date of purchase.

Related Kymanox Services:

• Process Operations