Some of these are compliance with various

Some of these are compliance with various selleck chemical Z-VAD-FMK legal requirements in association with the handling and shipping of biological materials, the use and preparation of reagents, media, and other supplies, a strategic plan for BRC future sustainability in order to avoid the loss of biological resources, and data management and staff qualifications and competence. However, in some other aspects, it goes too far and it would demand that each process, each preservation technique, and each authentication method, the supply of strains, would have to be independently accredited. Despite this, ISO 17025 could be used by a BRC to demonstrate its competence in the preservation and supply of authentic materials.ISO Guide 34, general requirements for the competence of reference material producers, has been recommended by accreditation bodies to be the most suitable for BRCs.

However, this guide was written for reference material producers and used for the calibration of measuring equipment and for the evaluation or validation of measurement procedures such as pharmacopoeia standards and substances. There are some differences that may confuse or cause problems when applying it to living biological material. Assignment of property values and their uncertainties may be problematic, but it is possible that suitable values could be established for living materials. The guide also states that the reference material producer shall use documented procedures based on accepted statistical principles for the assignment of property values and lays down the procedures on which this should be based.

Many of these principles cannot be applied directly to living cells, and this must be taken into account in documents that would give guidance on the accreditation procedure for BRCs. The implementation of ISO guide 34 requires the additional implementation of other guides. Amongst these is ISO Guide 31 which requires a statement of the certified property values, their meaning, and their confidence limits. It summarises the content and reason for a certificate Carfilzomib which condenses all the information about a provided sample. Certificates are becoming increasingly necessary with the increase in the number of reference material producers and would have to be designed for each strain in the collection. Although ISO Guide 34 needs closer scrutiny, the concepts described could be applied to living reference materials.The EU project (QLRT-2000-00221) European Biological Resource Centres Network (EBRCN) consortium recognised the need for a specific standard. The key elements of existing guidance were brought together and a European BRC Standard drafted. This was delivered to the OECD and formed the basis of the OECD best practice guidance.

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