We have recently tech transferred a product from India that uses target tablet weight adjustment for compression based on IPQC blend assay.
E.g. The target weight of product A is at 600 mg based on the product formula and the IPQC assay obtained is at e.g.97%. Adjustment of the target tablet weight for compression is then performed to obtain a theoretical assay of 100% which is at 619 mg/tablet. With this practice, the compression settings will then use 619 mg as the target tablet weight.
From my end, so far I have been unable to find any relevant guideline from ASEAN, ICH, FDA and EMA on the acceptance of this practice. Can the experts here provide some insights to this practice based on your respective vast industry experiences and any relevant supporting guidelines that explain / justify this practice?
Many thanks.