GROUPING (sometimes referred to as bracketing or matrixing) of products for the preparation of PQRs may be acceptable, if adequately justified. It is usually only acceptable if the amount of batches manufactured annually for each product within the group is LOW, the grouped products are of the same pharmaceutical form CONTAINING the same or very similar active ingredients and are manufactured USING the same equipment. Acceptability will be assessed during INSPECTIONS on a case-by-case basis.

Grouping (sometimes referred to as bracketing or matrixing) of products for the preparation of PQRs may be acceptable, if adequately justified. It is usually only acceptable if the amount of batches manufactured annually for each product within the group is low, the grouped products are of the same pharmaceutical form containing the same or very similar active ingredients and are manufactured using the same equipment. Acceptability will be assessed during inspections on a case-by-case basis.