Prospective validation should include, but not be limited to the following:
a) Short description of the process;
b) Summary of the critical processing steps to be investigated;
c) List of the equipment/facilities to be used (including measuring / monitoring / recording equipment) together with its calibration status
d) Finished product specifications for release;
e) List of analytical methods, as appropriate;
f) Proposed in-process controls with acceptance criteria;
g) Additional testing to be carried out, with acceptance criteria and analytical validation, as appropriate;
h) Sampling plan;
i) Methods for recording and evaluating results
j) Functions and responsibilities;
k) Proposed timetable.
Using this defined process (including specified components) a series of batches of the final tissues or cells may be produced under routine conditions. In theory the number of process runs carried out and observations made should be sufficient to allow the normal extent of variation and trends to be established and to provide sufficient data for evaluation. It is generally considered acceptable that three consecutive batches/runs within the finally agreed parameters would constitute a validation of the process.
Batches, where applicable, made for process validation should be the same size as the routine scale batches.