Ab

Dhaka, Bangladesh

SUMMARY REPORT OF ANNUAL PRODUCT QUALITY REVIEW

OF PROVASC 10 TABLET

INTRODUCTION
Annual product quality review is defined by a documented review procedure of a product quality
when carried out of product annually. Here annual product quality review of Provasc 10 Tablet is
summarized for the year 2015.
In the ACME Laboratories Ltd. (SDU) this product was started to manufacture since 2011. At that
time the name of this plant was ASPL. Provasc 10 Tablet has been validated only for export
purpose and during that period Batch# T0575037, T0575038 & T0575039 were manufactured as
process validation batches. All the batches contain 100000 tablets. At this time the review period is
from January 2015 to December 2015 and number of batches are 16. It is mentioned that since
1st Feb. 2014 The ACME Specialized Pharmaceuticals Ltd. has been merged with The ACME
Laboratories Ltd. as on change proposal COR/004/14 and consequently the name & logo changed
from ASPL to SDU. All the batches have been manufactured and packed for commercial purpose
in the same plant.

OBSERVATIONS
1. The potency of active ingredients is within the limit.
2. The average assay of Provasc 10 Tablet is 101.14% against 10.14 mg. The individual
assay is graphically shown & relative standard deviations calculated for Provasc 10 Tablet,
which is 0.708 %.
3. The yield percentages of product batch numbers T0575037 to T0575053 is within limit
which is graphically shown & average yield is 98.37 %. The relative standard deviation is
0.223 %.
4. Dissolution test results of all batches comply with the specification which is graphically
shown & average dissolution is 98.94 % (for Lowest) and 101.81 % (for Highest). The related
standard deviation is calculated for dissolution rate in Intestinal Buffer which is 5.856 % (for
Lowest) and 5.916 % (for highest).
5. Environmental conditions like room temperature and relative humidity found under
controlled.
6. Assay has been performed by UV method from the batch T0575037 to T0575053, results
found within the limit.
7. All in process test like Average weight, Uniformity of weight & Disintegration test of all
batches comply with the specification.
8. Raw materials of all batches were well accepted and all are procured from approved
sources.
9. No deviation & change control raised in manufacturing and analysis during review period.
10. Retention samples were physically checked & found satisfactory.
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11. No customer complaint, rework, recall & return goods received during the review period.

CONCLUSION & RECOMMENDATION:

This is the issue of Annual Product Quality Review of Provasc 10 Tablet. All the 16 batches
manufactured in the year 2015 have been considered for this Quality Review. According to SOP
(07-04-QA-019, Rev. 04) all the points are checked and found to comply with the assigned
specification.

In conclusion from above mentioned observations this can be stated that there is no unusual trend
on quality of this product as well as all the parameters moreover documentary evidences are found
satisfactory which support the consistency of the process. From the summary & observations it is
recommended that there is no need to revalidate the process of Provasc 10 Tablet until any
significant change done in the manufacturing process, product quality and in the facilities.

ENCLOSURE
a) Raw & Primary (Product Contact) Packaging materials review of Provasc 10 Tablet (Appendix-
A)
b) Analytical reports of Provasc 10 Tablet from batch no T1665001 to T1665029 (Appendix-B2).
c) Out of Specification result of Provasc 10 Tablet (Appendix-C).
d) Deviation Management of Provasc 10 Tablet (Appendix-C).
e) Change control Management of Provasc 10 Tablet. (Appendix-C).
f) Basic Data Anomalies of Product Quality Review of Provasc 10 Tablet. (Appendix-D).
g) Marketing authorization variations for Local and Export (Dossier) of Provasc 10 Tablet
(Appendix-E).

h) Validation and Stability of Product Quality Review of Provasc 10 Tablet (Appendix-F).

i) Corrective Actions from Previous Quality Review Reports & Implementation (Appendix-G).
j) Technical Agreements & Qualification Status of Relevant Critical Equipment and Utilities
(Appendix-H).
k) Relative standard deviation for yield % of Provasc 10 Tablet.
l) Relative standard deviation for assay % of Provasc 10 Tablet.
m) Relative standard deviation for dissolution% of Provasc 10 Tablet.
n) Graphical representation of yield%, assay% & dissolution% of Provasc 10 Tablet.

Contribution Name Designation Signature Date

Prepared by Md.Naim Hasan Jr. Officer, QA

Approved by Modhusudan Shome Head of Quality Assurance

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Authorized by S A B M Shahadat Ali Head of Quality Operation

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