Ab

(Solid Dosages Unit)

Dhaka, Bangladesh

APPENDIX-B
SUMMARY REPORT ON NON-CRITICAL PACKAGING PARAMETERS OF
METRONIDAZOLE 200 MG TABLETS
(Batch Size # 299.862 Kg / 546,000 Tablets)

Some non-critical parameters are observed during primary packaging like, % yield, reconciliation and
loss/gain of packaging materials; these are as follows:

Packaging Stage:

BATCH NO.
STAGE / ITEMS RANGE
(T2940001)
Theoretical Yield (%) : (97.00-
99.99 %
Primary 100.00)%
Packaging Actual Yield : (96.00-100.50)% 96.33 %
Reconciliation: NMT (±2%) 0.008 %
Loss/ gain : ± 5% 0.76 %
ALU-Lid Foil
Reconciliation :± 2% 0.11 %
Loss/ gain : ± 5% 0.68 %
Bottom Film
Reconciliation :± 2% 0.21 %
Theoretical Yield (%) : (98.00-
100.00 %
Secondary 102.00)%
Packaging Actual Yield : (97.00-103.00)% 95.82 %*
Reconciliation: NMT (±2%) 0.00 %

Loss/ gain : ± 5% 6.76 %**

Carton
Reconciliation :± 2% 0.00 %

Conclusion: From the above data it has been observed that the % of actual yield & Loss/gain % of
carton are out of limit in secondary stage. Percentage (%) of actual yield* is out of limit due to excessive
sample for PV batch & this limit will be reset after completion of three validation batches & seven
commercial batches based on the trend analysis of these batches. Percentage (%) of Loss/gain** of
carton is out of limit due to de-cartoning for sterilization process & this limit also be reset after completion
of three validation batches.

Prepared by : Checked by : Approved by:

Jarin Rahman Moromi Md. Enamul Haque Mahmudul Hasan

Executive, QA Sr. Executive, QA Deputy Manager, QA

Summary on Non-Critical Packaging Parameter Page 1 of 1 Metronidazole 200 Mg Tablets