Today’s FAQ Friday is dedicated to World Quality Month!
What are the Quality Attributes of InstantGMP Manufacturing Execution System?
Quality is “built-in” to all aspects of the InstantGMP™ manufacturing execution system. Starting with a “Quality by Design” approach, this electronic batch record system and the SOPs were developed at the same time by a team of manufacturing experts and quality assurance professionals who worked together throughout design, validation, and implementation.
Quality begins when the materials for manufacturing execution systems are identified and entered into the electronic system, where a unique part number is assigned. Vendors for each material must undergo a compliance audit and be approved by a Quality Manager before they can be used. Each material must have sampling instructions, sampling handling requirements, and tests as part of complete specifications, which must be approved before the materials can be purchased.
Specifications and handling instructions are entered online and approved by a Quality Manager with a digital signature. When materials are received at the warehouse, they are inspected and automatically moved into the inventory control section of the database. A Quality Manager must review all of its electronic documentation before making a disposition decision and moving the material along in the system.
Master Batch Records are written by manufacturing experts and are reviewed and approved by a Quality Manager. Quality Assurance then issues the Batch Production Records and continually monitors the process so they can quickly respond to issues or deviations. When the batch manufacturing is completed, a
Quality Manager completes their final review and provides a final disposition of the batch.
At each step of this process, the SOP requirements are automatically followed since the instructions have been written into the software. Documentation and project status are always visible online to the project team and to all necessary sponsors.