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Clinical grade hPSC lines and Good Manufacturing Practice (GMP)
GMP conditions include 5 fundamental pillars:
‐ Tra c e a b ility : Set of measures, actions and procedures to identify and register each product from its origin to the final destination.
‐ Documentation: SOPs. Description of activities and processes. Registration and verification of activities. Validation: Verification of manuphacturing process.
‐ Quality control: A quality management system (QMS) and Quality Assurance (QA).
‐ Training: Training and continuous qualification for all staff members in production processes and quality regulations.
PCC Stem Cells - ESHRE BCN 2018
Overview of intra and inter-organisational relationships in the establishment of a GMP hESC production capacity
Clinical grade hPSC lines and Good
Manufacturing Practice (GMP)
• Clinical grade lines need to be established according GMP conditions in facilities with a relevant product manufacturing license under strict quality assurance and must meet with all ethical and legal requirements.
• Generation of hPSCs under GMP conditions includes
 tissue sourcing
 hESC derivation or hiPSC generation
 Expansion
 testing
 storage
• Compliant GMP hESC and hiPSC have been generated
• hPSC lines established in standard conditions have been adapted to culture in GMPconditions(additional testing)
PCC Stem Cells - ESHRE BCN 2018
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PRECONGRESS COURSE 10 I BARCELONA, SPAIN – 1 JULY 2018 17