Ab

(Solid Dosages Unit)

Dhaka, Bangladesh

INTERIM PACKAGING VALIDATION

REPORT
METRONIDAZOLE 200 MG TABLETS
(Each Tablet contains Metronidazole BP 200 mg)
Batch Size # 299.862 kg / 546,000 Tablets
The scope of this study is to validate the packaging procedure (Primary & secondary) of
METRONIDAZOLE 200 mg TABLETS. (Each Tablet contains Metronidazole BP 200 mg), Batch size #
299.862 kg / 546,000 Tablets pack size 3 X7’ s Tablets) according to the process validation protocol:
PV-P/SDU–R&D/044 (Rev. No.: 02).
Manufacturing Process (From dispensing to compression) of this product has already been validated
having the batch number T2944001, T2947001 & T2948001 following the protocol number VLD-PVP-
007/14 & PV-P/SDU-R&D/020). First batch (T2944001) was manufactured following the protocol: VLD-
PVP-007/14 & second & third (T2947001 & T2948001) batches were manufactured following the
protocol: PV-P/SDU-R&D/020.
To validate the packaging procedure of this said product, three commercial batches will be considered
using the same batch size, pack size & equipment. Among these three batches, only one batch (B/N:
T2940001) has been packed following the approved BPR & approved packaging validation protocol.

All data generated from this batch are compiled in this report & consists of:

Appendix-A: Summary of critical packaging parameters.

Appendix-B: Summary of non-critical packaging parameters.
Appendix-C: Summary of analytical test results of finished product.

During packaging validation, all critical parameters were executed considering specification of critical
parameters.

The Hoonga Blister Packaging Machine (PRBPM-13) was used for primary packaging of this packaging
validation batch.

The forming station temperature was executed as 130 ºC against the range of (130±10) ºC which was
found within limit. The sealing station temperature was executed as 195 ºC against the range of

Interim Packaging Validation Report Page 1 of 2 Metronidazole 200 mg

Tablets
 Ab
(Solid Dosages Unit)
Dhaka, Bangladesh

INTERIM PACKAGING VALIDATION

REPORT
METRONIDAZOLE 200 MG TABLETS
(Each Tablet contains Metronidazole BP 200 mg)
Batch Size # 299.862 kg / 546,000 Tablets
(200±20)ºC which was found within limit. The cooling station temperature was executed as 18 ºC
against the range of (18±4) ºC which was found within limit. The machine speed was maintained as 90
RPM against the range of (120±20) RPM which was found out of limit which has no impact on the
quality of the product. After completion of three validation batches, the limit of machine speed will be
reset based on the resulted value from three validation batches. The IPC results for this batch were
compared with each other and it was found within specifications.

During Secondary Packaging, Automatic Cartooning Packaging Machine (PRACPM03) and

Serialization Machine (SPRSM01) were used. Secondary packaging validation & serialization operation
were performed following approved BPR & protocol and there is no anomalies have been observed.

Analytical & microbial test of finished product have been performed using validated method and
calibrated equipment. All test results are found within the approved specifications.

CONCLUSION:
Based on the above documentation, data generated from this batch analysis (T2940001), it is
considered that this batch has been manufactured following the GMP, approved BPR & protocol & no
significant changed has been observed. So, following the same procedure, equipment & document next
two batches may be packed. After completion of three batches final packaging validation report will be
prepared & based on the recommendation of this report commercial BPR will be prepared.

NAME DESIGNATION SIGNATURE DATE

PREPARED BY JARIN RAHMAN MOROMI EXECUTIVE, QA
CHECKED BY MD. ENAMUL HAQUE SR. EXECUTIVE, QA

Interim Packaging Validation Report Page 2 of 2 Metronidazole 200 mg

Tablets
 Ab
(Solid Dosages Unit)
Dhaka, Bangladesh

INTERIM PACKAGING VALIDATION

REPORT
METRONIDAZOLE 200 MG TABLETS
(Each Tablet contains Metronidazole BP 200 mg)
Batch Size # 299.862 kg / 546,000 Tablets
APPROVED BY MAHMUDUL HASAN DEPUTY MANAGER, QA

Interim Packaging Validation Report Page 3 of 2 Metronidazole 200 mg

Tablets