Ab

Dhaka, Bangladesh

SUMMARY REPORT OF ANNUAL PRODUCT QUALITY REVIEW

OF APITAC-100 TABLET

INTRODUCTION
Annual Product Review verifies the consistency of the existing manufacturing process. It also
helps to determine the quality and process defects of the products. It determines the defects and
possible improvements of the method and process. Trend of the yield, analytical results,
manufacturing parameters of the products are also highlighted.

It reviews the quality of raw material and packing material used for the product. Trend of these
materials indicates the quality of the material and the supplier also. In-process and the finished
product results are reviewed to determine the consistency of the product quality.

Quantity of the final product is reviewed by the trending the yield of every batch. Out of
specification helps to determine the process defects during the production of the specific product.
Failure of batch is also included in APQR to determine the batch rejection of the product. Stability
study and its trend help to determine the defects regarding the product stability.

APQR helps to determine the need of re-validation of the process and effect of any improvement
made previously. Corrective and preventive actions and their impact on product quality are also
reviewed and determined.

Here annual product quality review of Apitac 100 Tablet has been 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. During that period Batch# T1662001, T1662002 &
T1662003 were manufactured as process validation batches. All the batches contain 400000
capsules. At this time the review period is from January 2015 to December 2015 and number of
batches are 29. All the batches were manufactured and packed for commercial purposes.

OBSERVATIONS
1. The potency of active ingredients is within the limit.
2. The average assay of Apitac 100 Tablet is 99.73% against 99.73 mg. The individual assay
is graphically shown & relative standard deviations calculated for Apitac 100 Tablet, which is
1.038 %.
3. The yield percentages of product batch numbers T1665001 to T1665028 is within limit but
batch no T1665029 is below the limit which is graphically shown & average yield is 98.64 %.
The relative standard deviation is 0.945%.
4. Dissolution test results of all batches comply with the specification which is graphically
shown & average dissolution is 98.42 % (for Lowest) and 102.44 % (for Highest). The related
standard deviation is calculated for dissolution rate in Intestinal Buffer which is 1.709 % (for
Lowest) and 1.672% (for highest).
Summary Report of APQR of Apitac 100 Tablet’2015 Page no. 1 of 3
 Ab
Dhaka, Bangladesh
5. Environmental conditions like room temperature and relative humidity found under
controlled.
6. Assay has been performed by UV method from the batch T1665001 to T1665029, 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.
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 Apitac 100 Tablet. All the 29 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 Apitac 100 Tablet until any
significant change done in the manufacturing process, product quality and in the facilities.

Summary Report of APQR of Apitac 100 Tablet’2015 Page no. 2 of 3

 Ab
Dhaka, Bangladesh

ENCLOSURE
a) Raw & Primary (Product Contact) Packaging materials review of Apitac 100 Tablet (Appendix-
A)
b) Analytical reports of Apitac 100 Tablet from batch no T1665001 to T1665029 (Appendix-B2).
c) Out of Specification result of Apitac 100 Tablet (Appendix-C).
d) Deviation Management of Apitac 100 Tablet (Appendix-C).
e) Change control Management of Apitac 100 Tablet. (Appendix-C).
f) Basic Data Anomalies of Product Quality Review of Apitac 100 Tablet. (Appendix-D).
g) Marketing authorization variations for Local and Export (Dossier) of Apitac 100 Tablet
(Appendix-E).

h) Validation and Stability of Product Quality Review of Apitac 100 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 Apitac 100 Tablet.
l) Relative standard deviation for assay % of Apitac 100 Tablet.
m) Relative standard deviation for dissolution% of Apitac 100 Tablet.
n) Graphical representation of yield%, assay% & dissolution% of Apitac 100 Tablet.

Contribution Name Designation Signature Date

Prepared by Md.Abul Bashar Jr. Officer, QA

Approved by Modhusudan Shome Head of Quality Assurance

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

Summary Report of APQR of Apitac 100 Tablet’2015 Page no. 3 of 3