BS ISO 21899:2020 Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks.
7 Processing method implementation
7.1 Targets for method implementation
7.1.1 The biobank laboratory shall define and document tne periormance requirements ior the implementation of every processing method that will be validated (see fJj.
7.1.2 When implementing a processing method developed or adopted by the hiobank laboratory, the scope in terms of types of intended downstream analytical or other uses shall be defined and considered, in order to ensure that the method is fit for purpose.
7.2 Processing method implementation
7.2.1 The biobank laboratory shall implement standard processing methods only after verification and a statement of compliance, issued by competent staff from the biohank laboratory, for all predetermined requirements. All verification related records and statements, issued by the biobank laboratory, shall be maintained for a predefined period of time.
7.2.2 For non-standard processing methods, the first step for the implementation of a processing method is a feasibility assessment. The feasibility assessment shall be done in case of a biobank laboratory-developed or a modified standard processing method.
NOTE The objective of the feasibility assessment is to determine if the planned method is feasible. Biological materials that are used in feasibility studies shall be of the same or similar type to
those that will ultimately be used with the method. Pooled biological material can he used. Detailed records of the techniques/methods used and the results shall be maintained. The output of the feasibility study shall be a preliminary version of an SOP.
7.2.3 The second step for non-standard processing methods is the optimization of the method. Optimization applies to biobank laboratory-developed methods or to standard methods that have been modified by the biobank laboratory. Relevant parameters of the method shall be defined and optimized following an experimental plan. The definition of these parameters shall be based on a risk-based approach, according to the specific method (e.g. centrifugation speed, elution time and/or temperature, fixation time). The optimization parameters, the experimental plan, and the data analysis procedures shall be documented. Plans shall be updated as implementation proceeds and effective communication amongst all personnel involved shall be ensured. The results and conclusions shall be documented. The output of the optimization study shall he an updated version of the SOP released for validation.
8 Initial validation of a processing method
8.1 General
The validation of a method is the procedure by which the biobank laboratory shows, with experimental and documented evidence, that the method is fit for purpose. Method validation shall be performed by trained and competent personnel (e.g. specifically trained, experienced, board certified or qualified personnel) according to a validation plan with predefined acceptance criteria.BS ISO 21899 pdf download.