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 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 test as part of complete specifications which have to be approved before the materials can be purchased.
handling instructions are entered on-line and approved by a Quality
Manager with a digital signature. When materials are received at the
warehouse, they are be inspected and automatically moved into the inventory control section
of the database. A Quality Manager must review all of it’s 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 be written into the software.
Documentation and project status are always visible on-line to the project team and to the sponsor.