Document Code:

HMA/QA/APQR/20.001
VersionNumber:001
ANNUAL PRODUCT QUALITY REVIEW
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ANNUAL PRODUCT QUALITY REVIEW

(YEAR–2020)

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

Protocol Date : 16/01/2020

Total No. of Pages : 16 (Including Annexures)

PRODUCT NAME: DELE-JECT 2ML HYPODERMIC SYRINGE AND

NEEDLE
COMPOSITION: Each comprises of a barrel graduated to 2ml, 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: 10 blisters of 10 pairs of 2ml hypodermic
Needle and syringe packed in printed inner cartons.

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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-v

Annexure(ii) Graphical Representation for Data obtained---------------------------vi-xi

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1 LIST OF BATCHES MANUFACTURED:

The total no. of batches produced within the period of January, 2020 to December,
2020 was 113 batches i.e., from Batch no. B2S200101 to B2S201215.

2 RETENTION SAMPLES:
Three Hundred and Thirty-Nine (339) pairs of syringe and needle from each batch is kept in
the controlled sample room. These 339 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 2ml Hypodermic Syringe and 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 nor 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 of Jan. 2020 to Dec. 2020.

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

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8 NON-CONFORMANCE:
None of the batches manufactured during period of Jan. 2020 to Dec. 2020 showed 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:
There was no formal market complaint received/recorded for this product during the period
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 they gave consistent results which was 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 recorded for the product during the period under review.

14 RETURNED GOODS FROM MARKET:

None of the finished goods produced throughout the year were recorded to be returned from
the market.

15 SALVAGED GOODS:
There was no salvaging of goods for the period of Jan. 2020 to Dec. 2020.

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16 SUMMARY & CONCLUSION FOR (PROCESS) VALIDATION:

One Hundred and Thirteen (113) batches of DELE-JECT 2ml Hypodermic Syringe and
Needle have been manufactured with same manufacturing formula since Jan. 2020 to Dec.
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 113 batches of DELE-JECT 2ml Hypodermic Syringe
and 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