19.2 Reference documents for tissue banking - Tissue banking: general principles

The advice contained in these guidelines is believed to represent acceptable practice at the time of writing. It is policy to revise these guidelines as new developments occur. However, it may not be possible to do so at the time of such change and the guidelines should therefore be used with due regard to current acceptable practice.

The guidelines in chapter 19, chapter 20 and chapter 21 apply to tissue banking activities within the UK Blood and Tissue Services. They must be read in conjunction with the other sections of the guidelines including regulatory environment in the UK, quality in Blood and Tissue Establishments, microbiology tests for donors and donations and labelling of human tissue products.

Reference should be made to the current version of the Tissue (Deceased Donors) Donor Selection Guidelines and the Tissue (Live Donors) Donor Selection Guidelines.

Other key documents relating to tissue banking are:

• Guide to the quality and safety of tissues and cells for human application produced by the European Directorate for the Quality of Medicines and Healthcare (EDQM)
• Microbiological safety guidelines produced by the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO)
• Rules and Guidance for Pharmaceutical Manufacturers and Distributors [MHRA, 2022]
• EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines (2008 revision)
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices
• The Retention and Storage of Pathological Records and Specimens [RCPath and IBMS, 2015]

References

Medicines and Healthcare products Regulatory Agency (MHRA) (2022). Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022. London: Pharmaceutical Press.

Royal College of Pathologists (RCPath) and the Institute of Biomedical Science (IBMS) (2015). The Retention and Storage of Pathological Records and Specimens, fifth edition.