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. 2021 Aug 10;16(8):1853–1867. doi: 10.1016/j.stemcr.2021.07.009

Table 3.

Recommendations for a practical quality assurance framework

# Guidance 4. Recommendations for a practical quality assurance framework
4.1 Ensure that SOPs are written for all core processes, such as routine iPSC culture, generating batches, managing cryo-storage storage, and guidance on health and safety procedures. These SOPs should be centrally available and version controlled
4.2 Implement a system to investigate issues, find root failures, and implement corrective actions across all staff members to avoid repeat occurrences. This can be done in a practical approach, which does not need to be cumbersome
4.3 Have a documented system of staff training with a training manual in key laboratory procedures and principles of best practices
4.4 Introduce a system for assigning batch (or lot) identifiers and including batch-specific information, such as culture conditions and passage numbers, on vial labels
4.5 An inventory of materials stored within fridges and freezers is recommended with a yearly check included to keep records up to date with responsibility assigned to specific staff member(s)
4.6 Ensure that, prior to distribution of any cell stocks, critical QC such as screening for Mycoplasma and checking cell line identity is completed and the data available for cell line recipients
4.7 Keep records of all incoming and outgoing cell material, including source, recipient, sample type, date of transfer, and pseudonymized/anonymized sample identifiers
4.8 Routinely monitor performance of key equipment, such as fridges, freezers, and biosafety cabinets, including regular maintenance where required