Ab

Dhaka, Bangladesh

PV Status with Hold Time Study

Hold Time Status

Status Quantity Activity

SDU Unit 1. Protocol preparation and
Total Products 84 Execution.
2. Make Schedule of hold time
Hold time completed 17 study
Ongoing 23 3. Management of Hold time
Remaining for Hold time study 44 study sample .
BLS-Solid 4. Communication with QC
about testing of hold time
Total products 105 sample.
Total product validated 08 5. Communication with QA
Pending to be validated 11 about sampling time to time.
Hold time completed N/A 6. Investigation of Deviation or
OOS if require
BLS Unit 7. Arrange the paste and coating
Total Products 132 solution preparation
BLS validated product 42 separately.
Pending to be validated 08 8. Collect the QC and MIC
report of hold time study and
Ongoing 02 checking.
Remaining for Hold time study(already 9. Final report preparation.
40 10. Archiving of all Hold time
validated)
documents.

PV Status
SDU
Total products 84
Running PV 06 1. Checking the process
validation protocol
Product will be validated 15 2. Final approval of process
BLS-Solid validation protocol
Running PV 03 3. Preparation of Checklist of
Pending to be validated (First Priority) 22 before process validation
activity
Pending to be validated (Second Priority) 25 4. Monitoring of process
BLS Unit validation activity of 3
Running validation 02 consecutive batches.
Pending to be validated 11 5. Collect the batch record and
check the following batch
Hormone Unit
record.
Total products 86 6. Preparation of Process
validation report
Running PV 02 7. Preparation of process
validation file.
Penicillin Unit

Total products 19

Running PV 03
 Ab
Dhaka, Bangladesh

Status Quantity Activity

Cephalosporin Unit

55 (50 human and 5

Total products
veterinary)

Running PV 01

Pending to be validated 02

PO Status
SDU
Running PO 06
1. Checking of Process
BLS-Solid Optimization protocol
Running PO 06 2. Final approval of Process
Pending for PO 46 Optimization protocol
3. Checking of checklist before
BLS-Unit
preparation of process
Running PO 03 Optimization
Pending from PO 03 4. Monitoring of process
Hormone Unit optimization activity
5. Checking of process
Running PO Optimization report.
21
6. Checking of process
Penicillin Unit optimization file and achive.
01
Running PO
Verification
SDU/BLS/BLS-Solid 1. Checking the process
verification protocol
Running Verification in SDU 02 2. Final approval of process
Running Verification in BLS-Solid 05 verification protocol
3. Monitoring of process
Hormone Unit verification activity
4. Collect the batch record and
Hormone total product 86
check the following batch
Running PV 02 record.
5. Preparation of Process
verification report
Running PO 21 6. Preparation of process
verification file.

Summary:
 Ab
Dhaka, Bangladesh

Hold Time Study

Total Hold time study status in SDU 67 Products remaining

Total Hold study in BLS-Solid Not started yet

Total Hold study in BLS Unit 2 products ongoing and others are not started

PO/PV/Verification
Total products to be validated (also included running)
SDU
21, to be optimized 06 and to be verified 02
Total products to be validated (also included running,
BLS-Solid first priority and 2nd priority) 50, to be optimized (also
included running) 52 and to be verified 05
Total products to be validated (also included running)
BLS
13, to be optimized (also included running) 06
Total products to be validated (also included running)
Hormone Unit
02, to be optimized (also included running) 21
Total products to be validated (also included running)
Penicillin Unit
03, to be optimized (also included running) 01
Cephalosporin Unit Total products to be validated (also included running) 03