StemFit™ GMP Guideline FAQ

• Are there any changes from previous (non-GMP) product? No changes in composition.
• What changes were made in production process? Filters used for sterilization of product solutions were conventionally 0.2 µm pore diameter filters. For quality improvement, this has been changed to a filter with a pore size of 0.1 µm, which is capable of capturing mycoplasma. The filter material has not been changed from PES. There are no other changes in the manufacturing process. 
• New CoA format? How are QC tests performed? Test methods for pH, osmolality, sterility, endotoxin, and mycoplasma refer to Japanese Pharmacopoeia (JP). Details of the test methods are given in the new CoA as corresponding JP chapter numbers.
  All QC tests are validated. 
• What is the QMS in place? (Local 9001,ASQUA)? The QMS (Quality Management System) follows the Ajinomoto System of Quality Assurance (ASQUA). Manufacturing and product release testing of this product are managed in accordance with the GMP standards Ajinomoto formulated for culture media for regenerative medicine.
  
  ASQUA, which means the Quality Assurance system of Ajinomoto Group, consists of common rules in Ajinomoto and actual operating rules in each organization. Common rules consist of Group Shared Policy on quality and safety, Ajinomoto Quality Assurance Regulations, Regulation for Quality Assurance, and ASQUA standards. ASQUA is consistent with ISO9001, as well as manufacturing management standards Hazard Analysis and Critical Control Points (HACCP), food, hygiene management standard, and good manufacturing practices (GMPs)
  
  (For more information: https://www.ajinomoto.com/quality_assurance/ajinomoto-system-of-quality-assurance)
  
  The GMP standards are prepared with reference to ICHQ7 and “Guidance for Aseptic Manufacturing Processes of Regenerative Medicine Products.
• How is sterility ensured for regenerative medicine products? Operator: Training, Qualification
  Monitoring: Environment, Operator
  Filter: Bacteria challenge test
  Process: PST(Process simulation test)
• Receiving inspection of raw materials? Appearance test and ID test by Raman spectroscopy or chemical test.
• Can you fill in our supplier questionnaire? Template using Rx-360 Supplier Assessment Questionnaire is available on a request basis. Please contact at stemfit@asv.ajinomoto.com or your usual contact of StemFit™ product.
• Can I audit the manufacturing site? For any audits, please make a prior request of at least 6 months before the desired performance of audits/inspections of the QMS and manufacturing facility.
• I would like to receive media in bags for our production.
  Do you have GMP grade bag media? Media in bags are available on a customization basis, please plan ahead for your production schedules, lead times can vary.