MONTHLY

REPORT
DATE: 10, NOV, 2022

P R E PA R E D B Y : M A N A R A L M O S H AWA H
PRODUCT QUALITY
REVIWE
First of all I proceeded my training in QA department under
supervision of dr.omniyah, We began step by step in product
quality review (PQR), in simple words i can summarize PQR in
five steps.

First week we accomplished first & second step,

1- ( recommendation from previous PQR report ) we investigate if
there’s any open CCF, Deviations, Non conformance from the last
year’s PQR.

2- general product and patch information. We go through batch

wallet file and SAP took the required information:

product name & strength

product code
API material name, code & supplier
Primary packaging material, vendor & code
Standard batch size (per market)
Pack size (per market)
Shelf life (per market)
PRODUCT QUALITY
REVIWE
Batch Information. We go through batch wallet file and SAP took
the required information:

Manufacturing Batch No (Bulk)

Packaging Batch No.
Produced Batch Size
Manufacturing Date
Packaging Date
API Lot Number
Batch Status (I,e Released)
PRODUCT QUALITY
REVIWE

second week we accomplished third & fourth step,

3- Technical Review

We go through batch wallet file, PAS-X data & SAP took the
required information:

Primary Packaging Material:

Packaging Batch No.
Primary Pkg. Material: Item Code & Lot No.

API Material Name & Code, & API Lot Number:

Testing results

Critical Evaluation of In-Process and Release Data: (i.e., Solid/

Oral Solid Dosage Form)
Include the batch no, and protocol no.

Finished Product Testing Results:

testing results/ analytical data

Yield Data:
Manufacturing Yield
Packaging Yield
PRODUCT QUALITY
REVIWE
second week we went through third & fourth step,
4- Quality System Review

We go through file, OOS_OOT_Master List_updated - Editable

from QA-Documentation/ SAP data, QMS, QC, Finished Goods
Return Log, Customer Complaint Master List, regulatory affairs
For the required information:

Batch Failure and Investigation

Deviation and Non-Conformance (OOT & OOS)
Changes, Change Control Form (CCF)
Stability Results
- Started
- Ended
Retained Sample Results (if applicable)
Review of Quality Related Returns, Complaints, and Recalls
- Returns (l.e., Return to Qassim Plant for Inspection)
- Complaints
- Recalls
Corrective actions
Equipment and Utilities Qualification Status
Validation/Qualification of Process/Product Summary
PRODUCT QUALITY
REVIWE
Contractual Agreement ( for licensor product only )
Adverse Event Report ( report file from head office )
Marketing Authorization
Variation Post Marketing Commitments
Recommendation From any Health Authority
Supply Chain Traceability of Active Substance
Conclusion: if any open Deviation or CCF we should include it with
the due date.
Recommendation and Scope of Improvements
 Graphical
Presentation
50

40

30

20

10

0
Batch 1 Batch 2 Batch 3 Batch 4 Batch 5

Third week we accomplished last step:

5- Graphical Presentation
Yield Trend Line Graph
Capability Performance Table (CpK) (Whichever is applicable)

For Solid/Oral Solid Forms:

- Hardness
- Average Wt with CPK
- Assay with CPK
- Thickness
- Disintegration
- Water Content
- Dissolution with CPK
- Manufacturing
- Packaging
 Graphical
Presentation
50

40

30

20

10

0
Batch 1 Batch 2 Batch 3 Batch 4 Batch 5

Third week we accomplished last step:

5- Graphical Presentation

For Other Dosages: Liquids, Semi-solid. Sterile

- pH
- Fill Wt./ Volume
- Assay
- Water content
- Density
- Specific gravity
- Manufacturing
- Packaging
 Appendix

last not least:

1- Stability Data Result

Started & Ended Stability Report

Appendix 1 from QC

2- List of Major Equipment Qualification and Calibration due date

Appendix 2 from
 Conclusion

During that period I reviewed and finished 10 PQR under

supervision of dr. Omniyah.

End of report..