I.
PURPOSE
To define a procedure to
perform Annual Product Review of finished APIs and Intermediates.
II.
SCOPE
The SOP is applicable for
all finished APIs and Intermediates manufactured in, Unit – V.
III.
RESPONSIBILITY
Head – Production
Head – QC
Executive – QA, Head - QA
IV.
ACCOUNTABILITY
Head - QA
V.
PROCEDURE
1.0
Annual product review shall be carried out for each
product manufactured in the previous calendar year.
2.0
Annual Product Review report should be completed by the
month of January.
3.0
Implementation of preceding year’s recommendations
should be reviewed along with Annual product review.
4.0
Annual product review should essentially include the
following steps
4.1
Trend analysis of the following parameters shall be
compiled product wise and batch wise.
4.1.1
pH
4.1.2
Water Content
4.1.3
Assay
4.1.4
Impurities
4.1.5
Sterility, Endotoxin, and Pyrogen test (incase of Sterile products)
4.1.6
Market complaint, investigations and planned
corrective action.
4.1.7
Review of critical in-process controls and key API
test results.
4.1.8
Review of all batches that failed to meet established
specifications and related investigation.
4.1.9
Review of any changes carried out to the process,
system or analytical methods.
4.1.10
Review of results of the stability-monitoring program.
4.1.11
Review of Product Recalls and corrective actions
taken.
4.1.12
Review of Disqualified vendors for raw material /
packing material.
4.1.13
Reprocessing and rework batches review, if any.
4.1.14
Review of revalidated process.
4.2
Quality Assurance shall prepare the Annual Product
review document and sends the document to production for checking.
4.3
Head production shall check the document for its
correctness.
4.4
Head QA shall approve the Annual product review
document.
4.5
Head QA shall mention the recommendations (if any) in
the report.
4.6
Annual product review records shall be maintained in
QA department.
VI. REVISION SUMMARY
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Version No.
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Revised on
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Reason for Revision |
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