What is PD ISO/TR 22758 about?
PD ISO/TR 22758 discusses the implementation guide for ISO 20387 for biobanking. PD ISO/TR 22758 outlines guidance to biobanks on how to implement the quality management, management, and technical requirements of ISO 20387. PD ISO/TR 22758 expands on aspects of ISO 20387. PD ISO/TR 22758 provides examples for illustration purposes. PD ISO/TR 22758 is equally applicable to newly established and existing biobanks.
PD ISO/TR 22758 helps biobanks address the competency of personnel and appropriate quality of biological material and data collections.
Note: PD ISO/TR 22758 does not apply to biological material intended for feed/food production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
Who is PD ISO/TR 22758 for?
PD ISO/TR 22758 on implementation guide for ISO 20387 for biobanking is useful for:
- Biobanks
- Organization, government entities, and academic institutions performing biobanking
- Regulatory authorities
Why should you use PD ISO/TR 22758?
At the time of acquisition, biobanks can perform acquisition, processing, and storage of BMaD for not yet-identified future use(s). The biobank can acquire the BMaD according to standard operating procedures (SOPs) appropriate for the projected end-use(s). Alternatively, biobanks can acquire BMaD in response to a request from a user. The user can specify criteria for the BMaD and/or SOPs developed or applied for that specific use.
PD ISO/TR 22758 provides the best practice guidance on Background information for the development of ISO 20387, Fitness for the intended purpose (FIP) (ISO 20387:2018, 3.24) in biobanking, Process landscape, and Conformity with ISO 20387 for implementation guide for ISO 20387 for biobanking.
PD ISO/TR 22758 provides General, Structural, Resource, Process, and Quality management system requirements on Guidance on the interpretation of selected ISO 20387:2018 text parts. This helps in achieving personnel and appropriate quality of biological material and data collections.