What is the Inspectorate’s position on pooling of samples within the same batch (e.g., 7 samples in one pool) for testing for sterility? The European Pharmacopoeia (Ph. Eur.) does not mention explicitly a pooling of samples for testing for sterility?

It is acceptable if companies pool samples for sterility testing with the membrane filtration method. However, it is not acceptable to pool samples when the direct inoculation method is used. Exceptions can be tolerated, when the volume of the sample-pool does not exceed 10% of the culture medium volume.