Document Code:

HMA/QA/APQR/20.001
VersionNumber:001
ANNUAL PRODUCT QUALITY REVIEW
Review:00 Page: 1 of 5

ANNUAL PRODUCT QUALITY REVIEW

(YEAR–2020)

Protocol No. : HMA /QC/APQR/QA/20.001

Protocol Date : 16/01/2020

Total No. of Pages : 12 (Including Annexures)

PRODUCT NAME: DELE-JECT 21G HYPODERMIC NEEDLE

COMPOSITION: Each comprises of a barrel graduated to 21G, a plunger, cap, a
hub (all made of Polymers); and a stainless steel needle
attached to the hub with the aid of epoxy gum.
PACK SIZE: Blister Packing: 20 blisters of 5 pairs of 21G hypodermic
Needle and syringe packed in printed inner cartons.

1
 Document Code:
HMA/QA/APQR/20.001
VersionNumber:001
ANNUAL PRODUCT QUALITY REVIEW
Review:00 Page: 2 of 5

INDEX Page

1.0 List of Batches manufactured ---------------------------------------------------------3

2.0 Retention Samples----------------------------------------------------------------------3
3.0 Trend Analysis--------------------------------------------------------------------------3
4.0 Regulatory Changes--------------------------------------------------------------------3
5.0 Change Control-------------------------------------------------------------------------3
6.0 Process Deviations---------------------------------------------------------------------3
7.0 Yield Deviations-----------------------------------------------------------------------3
8.0 Non Conformances--------------------------------------------------------------------4
9.0 Batch Failures--------------------------------------------------------------------------4
10.0 Market Complaints--------------------------------------------------------------------4
11.0 Changes in Formulation & Process-------------------------------------------------4
12.0 Vendors---------------------------------------------------------------------------------4
13.0 Batch Recalls---------------------------------------------------------------------------4
14.0 Returned goods from Market--------------------------------------------------------4
15.0 Salvaged Goods-----------------------------------------------------------------------4
16.0 Summary (For Process Validation) ------------------------------------------------5
17.0 Summary & Conclusion--------------------------------------------------------------5
18.0 Approval--------------------------------------------------------------------------------5

Annexure (i)- Chemical/Endotoxin test-----------------------------------------------------i

Annexure(ii) Graphical Representation for Data obtained-------------------------------ii-vii

2
 Document Code:
HMA/QA/APQR/20.001
VersionNumber:001
ANNUAL PRODUCT QUALITY REVIEW
Review:00 Page: 3 of 5

1. LIST OF BATCHES MANUFACTURED:

The total no. of batches produced within the period of September, 2020 to December,
2020 is 22 batches. i.e. from Batch no. B1G200901 to BDN201209.

2. RETENTION SAMPLES:
One Hundred and Ten (110) pairs of syringe and needle from each batch is kept in the
controlled sample room. These 110 pairs are kept in a controlled sample room throughout the
shelf life of the product. During this period the blistered product are monitored for the
following parameters:

a) Changes in physical appearance of the product

b) Changes in the reducing substances content of the product
c) Microbial growth
d) Leakages
e) Syringibility

3. TREND ANALYSIS:
Trend analysis of: DELE-JECT 21G Hypodermic Needle
Acidity/Alkalinity, Pyrogen, bond test, Penetration Force test and Reducing substance, were
carried on all the above batches.

4. REGULATORY CHANGE:
No regulatory changes as well as Master Formula Changes were made concerning these
products throughout the manufactured batches till the end of the year 2020.

5. CHANGE CONTROL:
No change control was recorded throughout the period September, 2020 to December, 2020.

6. PROCESS DEVIATIONS:
No process deviation was reported from the standard processes for batches manufactured
during the period September, 2020 to December, 2020.

7. YIELD DEVIATIONS:
There were very few cases of yield deviations. These deviations were due to rejection of
Blockages and leakages during injection molding, syringe and needle assembly operations.

3
 Document Code:
HMA/QA/APQR/20.001
VersionNumber:001
ANNUAL PRODUCT QUALITY REVIEW
Review:00 Page: 4 of 5

8. NON CONFORMANCE:
None of the batches manufactured during period September, 2020 to December, 2020.have
shown any analytical parameter outside the specification. Thus, all the batches met the
requirements as per the laid down specification.

9. BATCH FAILURES:
There was no batch failure observed for this product throughout the year under review and all
the batches met the quality requirements as per specifications.

10. MARKET COMPLAINTS:

No formal market complaint was recorded throughout the year under review.

11. CHANGES IN FORMULATION & PROCESS:

No change was made in the formulation as well as process in regular practice. It was
observed that every batch was manufactured by following consistent formulation and process
and thus, gives consistent results which is proved by the trend analysis for all the parameters
covered, expressed in graphical form.

12. VENDORS:
All the raw materials used in the production of these batches were sourced from tested
vendors only.

13. BATCH RECALLS:

There was no batch recall for product during the period under review.

14. RETURNED GOODS FROM MARKET:

There was no record of finished goods returned from the market throughout the year 2020.

15. SALVAGED GOODS:

There was no salvaging of goods for period of September, 2020 to December, 2020.

4
 Document Code:
HMA/QA/APQR/20.001
VersionNumber:001
ANNUAL PRODUCT QUALITY REVIEW
Review:00 Page: 5 of 5

16. SUMMARY & CONCLUSION FOR (PROCESS) VALIDATION:

Twenty-Two (22) batches of DELE-JECT 21G Hypodermic Needle have been manufactured
with same manufacturing formula since September, 2020 till December, 2020 and the yearly
APQR data shows the satisfactory trend throughout the period. Also the retained samples
prove that the product manufactured with the existing formulation is stable.

17. SUMMARY & CONCLUSION:

In the period under review, a total of 22 batches of DELE-JECT 21G Hypodermic Needle
were manufactured without any process deviation or any change and all the batches
manufactured were found satisfactory and within the set specification. The retained samples
do not reveal any out of specification or any change in the trend.
Based on the above Trend analysis of all the parameters attached in the annexures, it can be
concluded that product formula and process which was used for manufacturing the batches
gives consistent performance with the satisfactory trend for all the parameters and gives the
intended quality, efficacy and safety of the product.

18. APPROVAL
S/No Subject Name Designation Sign/Date
1.
Compiled by Quality Assurance Executive

2.
Reviewed by Asst. Quality Assurance Manager

3.
Approved by Quality Assurance Manager

4.

Authorized by Factory Manager