Proposed activity – To incorporate the provision f...

I reviewed the Attachment-I formula, the complete BPR, primary/secondary rejection flow, reconciliation references, de-blistering/de-foiling references, index, and revision history, and I have prepared the revised documents.

Formula review

The formula in the original Attachment-I was not acceptable as written. The main error is:

“Weight of rejected tablets (F): D – F” — this is mathematically incorrect; it must be D – E. (Attachment-I.docx)

I also found an important definition gap: the empty-blister and filled-blister weights must be defined as the average/approved weight of one blister, otherwise multiplying the weight by the number of rejected blisters is dimensionally unclear.

I finalized the calculation as:

R1 = Average/approved weight of one empty blister, kg
R2 = Average weight of one filled blister, kg
R3 = Number of rejected blisters
R4 = R2 × R3 = total gross weight of rejected filled blisters
R5 = R1 × R3 = total empty-blister packaging weight
R6 = R4 − R5 = net weight of rejected tablets, kg
R7 = Actual average tablet weight from BPR Section 7.1, mg

Equivalent rejected tablets = (R6 × 1,000,000) / R7

I deliberately changed the formula variables from A–F to R1–R7, because A–F are already used by the existing BPR for initial setting, in-process and process rejection quantities. For example, the existing BPR uses A/B for primary rejects and E/F for secondary rejects. (BPR 17005780.docx)

For secondary packing, I added the control:

Rejected quantity = Recoverable quantity + Non-recoverable quantity

and only non-recoverable product packs are carried into final process rejection F. For this BPR's 1×24 pack style, the tablet equivalent is F × 24. This is important because the current yield reconciliation ultimately works in tablet quantities. (BPR 17005780.docx)

BPR impact verified

Page(s)	Finalized change
1	BPR revised to BPR/PT/219/06; supersedes /05
2	Index corrected to actual BPR page ranges; the existing index did not match the physical content ranges. (BPR 17005780.docx)
3	Existing de-blistering instruction 3.15 removed and replaced with stage/equipment-wise rejection recording instruction. The old BPR specifically instructed de-blistering for repacking. (BPR 17005780.docx)
7	De-Blistering Machine / SOP/PT/001 removed from primary line-clearance equipment list. (BPR 17005780.docx)
13–14	Primary process reject B linked to new 8.4 Primary Stage-wise / Equipment-wise Rejection Record; old 8.4 “Record for Defoiled Tablets” removed. (BPR 17005780.docx)
31	Secondary packing instruction added for stage/equipment-wise rejection handling and recovery/re-verification
33–34	New 10.4A Stage-wise / Equipment-wise Secondary Rejection Record covering Cartonator, Track & Trace/2D Printing & Aggregation, Checkweigher, and Other Rejection. These equipment types are consistent with the equipment already identified in the secondary section. (BPR 17005780.docx)
54	Yield reconciliation updated so process rejection is linked to Sections 8.4 and 10.4A, with tablet-equivalent accounting
56	Packaging-material reconciliation wording aligned with stage/equipment-wise rejected/scrapped quantities
63	Revision 06 / CC/PL3/P/26/398 added to revision history
All 63 pages	BPR No. updated to /06 and page numbering normalized to x of 63

The final BPR has also been checked visually after rendering all 63 pages; the corrected Attachment-I was rendered and checked on both pages. I also verified that the operational references to the De-Blistering Machine, Record for Defoiled Tablets, and SOP/PT/001 are removed from the revised BPR.

The calculation is now mathematically coherent and reconciliation-ready. Final GMP/site acceptability should still be confirmed through your approved SOP/change-control process, particularly the approved method for determining average blister weight, balance resolution, and rounding convention.

Final files:

Download revised BPR – BPR/PT/219/06

Download corrected Attachment-I