HMA MEDICAL LIMITED

Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

DEVICE HISTORY RECORD (DHR)

FOR

DELEJECT 21G DISPOSABLE NEEDLE

Table of content P
Index 1
1.0 Product Description 2
2.0 Summary of Manufacturing Process 2
3.0 Bill of Materials 3
3.1 Raw material requisition manufacturing work order 3
4.0 Brief description of operations 4
4.1 Component Preparation 4
4.2 Dispensing 4
4.3 Line Clearance 4
4.4 Moulding Section 5
4.5 Preparation and Graduation of Barrel 6
4.6 Syringe Assembly 7
4.7 Blistering of Assembly Needle and Syringe 8
5.0 Production Flow Chart 9
 HMA MEDICAL LIMITED Page 1 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

6.0 Quality Assurance Procedure 1

6.1 In-process Quality Control in Injection Moulding 1
6.2 In-process Quality Control in Printing & Syringe Assembly 1
6.3 Blister Packing section in process check report 1
7.0 Packaging Procedures 1
7.1 Quality Assurance Authorization to pack 1
7.2 Issuance of packaging material 1
7.3 Line clearance 1
7.4 Packaging 1
8.0 Labelling procedures 1
8.1 Inner and Shipper Cartons coding 1
9.0 Sterilization procedure 1
9.1 Line Clearance 1
9.2 Terminal sterilization by Ethylene Oxide Gas 1
121 10.0 Final Batch Reconciliation 1
11.0 Post sterilization inspection and testing 1
11.1 Intimate Quality Control of completion and sampling 1
11.2 Sampling details 1
12.0 Inspection and release procedures 1
12.1 Deviation Approval Sheet 1
12.2 Certification of batch release 1

THIS DOCUMENT AUTHORIZES THE FOLLOWING DEVICE HISTORY RECORD FOR THE MANUFACTURE OF
DELEJECT 21G HYPODERMIC SYRINGE & NEEDLE

1.0 PRODUCT DESCRIPTION

Product Details
DELEJECT 21G DISPOSABLE NEEDLE
A. Descriptio UNIQUE ID NO: DHR. NO: DHR REV. NO.& DATE
n
QUANTITY OF DEVICE MAN Mfg. Date MFR REV. NO. & DATE
UFACTURED:
Expiry Date REF. MFR NO.

i. Product Size DELEJECT 21G DISPOSABLE NEEDLE

ii. Packaging Each pack contains: A single use 21G Disposable Needle
 HMA MEDICAL LIMITED Page 2 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

Description

Pack Size: Blister Packing of 20 blisters of 5 strands each, packed in printed inner cartons.
Carton Packing: 50 inner cartons in a corrugated shipper carton.
2.0 SUMMARY OF MANUFACTURING PROCESS
Document Issued By QA: Date: Document Received By: Date
This Document Supersedes:
Raw Weighing, Injection Needle Assembly Blistering Packaging Sterilization
Materials Crushing Molding
&Mixing
Unique I.D. No.
Date of Commencement/MFD

Date of Completion/EPD
Qty. Of Components
Produced (pcs)
Qty. of Re-run Generated kg (pcs)
Qty. of Waste Generated kg (pcs)
Checked By Shift Executive: Date: Time:
This batch has/has not been completed according to the instructions given in DMR No. …../………../00.
Deviation attached Yes/No
Actual Yield……………Pcs. Theoretical Yield……………(Pcs)Blistered 21G Needle. Qty of Re-run Generated………….kg(pcs) Qty of Waste generated……………kg
(pcs) . Total Yield…………………………%
Final DHR Checked By Date Final DHR Verified By Date
Prepared By Checked By Prodn.Mgr. Reviewed By: Approved By
Production .Exec. Qc Manager QA Mgr.

Date Date Date Date

FORMAT & DOCUMENT:

PREPARED BY: PRODUCTION IN-CHARGE SIGN & DATE:

CHECKED BY: PRODUCTION MANAGER SIGN & DATE:

APPROVED BY: QUALITY CONTROL MANAGER SIGN & DATE:

AUTHORIZED BY: QUALITY ASSURANCE MANAGER SIGN & DATE:

 HMA MEDICAL LIMITED Page 3 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

3.0 BILL OF MATERIAL

3 .1 RAW MATERIALS REQUISITION-MANUFACTURING WORK ORDER FOR NEEDLE 18G 21G 22G 23G

Sr. Raw Material(s) UOM Std. Qty. AR. No. Gross Tare Net Issued by Checked Verified
No weight weight weight Stores by Prod

Hub 18G 21G 22G 23G

1 Polypropylene Kg - 133.26 - 133.26

2 Colour Master Batch Kg - 0.078 - 0.078

Needle Caps

1 Polypropylene Kg 515.28 515.28 444.21 444.21

Assembled Needle

1 Cannula Pcs 871000 871000 871000 871000

2 Epoxy Bond Kg 11.846 6.968 6.887 6.887

3 Silicone Oil compound Kg 11.517 10.365 5.603 5.603

(A)

Blister Packing

1 Dialyzing Kg 107.50 107.50 107.50 107.50

2 PVC Film Kg 119.05 119.05 119.05 119.05

 HMA MEDICAL LIMITED Page 4 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

4.0 BRIEF DESCRIPTION OF OPERATION

4.1 COMPONENT PREPARATION
4.1.1 Cap and Hub
Caps and Hubs were molded wholly from virgin or a mixture of rerun and virgin polypropylene which shall be suitable as
pharmaceutical/medical grade, non-bleaching and non-toxic. Polypropylene was obtained from approved vendors and meets
material specifications as stated by current version of British Pharmacopeia 2022 and NIS 2020 only and molded as per SOP
No. HMA/PRD/SOP005-03 and shall meet all specifications as stated in these references. The production process involve
wherein molten plastic is injected into a mold cavity, imparting the syringe with its desired shape, precision moulding to form
the cap, hub and other components, ensuring each part meets exact size and shape specifications for optimal performance . This
method facilitates efficient mass production of syringes while maintaining consistent dimensions and high accuracy.
4.2 DISPENSING
 Manufacturing was carried out as per the requirement of the current GMP
 Followed personal hygiene requirements
 General cleaning of equipment, machines, utensils, and Weighing Balance calibration as per line clearance SOP
No. HMA/PRD/SOP004-03 was ensured.
 Batch size was made based on requirement. Prior clearance obtained from QA before commencement of work..
 All ingredients have been tested and released by the QC before use as per line clearance SOP No.
HMA/PRD/SOP004-03
 All rejected materials and runners were treated as per line clearance SOP No. HMA/PRD/SOP004-03
 Gowning of personnel was observed as per gowning procedure in SOP HMA/QAD/SOP014-05
 Environmental conditions and balance calibration and equipment were done and properly recorded.
 Dispensing of materials and ingredients were done as per SOP No: HMA/PRD/SOP003-00
 Dispensed materials were transferred to the appropriate production area

4.3 Line Clearance Checks (SOP No: HMA/PRD/SOP004-03) Date: ______________________

S/No Machinery/Equipment Capacity Previous product Cleaned Checked By Re-checked by

& Batch No On by Prod. exec. QA Officer
1 Weighing Balance
3 Hopper
4 Feeder
5 Conveyor line
6 Utensils
7 Receiver tray
8 Needle assembly
9 Tools & other accessories
12 Blistering machine
13 EO gas sterilizing chamber
 HMA MEDICAL LIMITED Page 5 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

4.4 MOLDING SECTION

Previous Product/Batch: UNIQUE ID NO:
Cleaned Checked Verified by
Check List by (QA Exec.)
On By
Check Area Cleanliness (floor, walls, ceiling).
Check weighing balance, scoops and drums are cleaned
Check the mixer is free from foreign particle and cleaned properly
Check if mold is cleaned
Check if automatic loaders are cleaned & properly fitted
Check if the heating bands and chargers are working properly
Check injection screw if cleaned & properly flushed
Check if the product shooters are cleaned & intact.
Confirm if the chillers are on and working properly.
Check machine settings for compliance with mold technical card
Check and ensure remnant of previous batches have been removed
Check DMR to ensure it is updated properly up till this stage.
Environmental Conditions: DONE BY CHECKED BY
Std. Temp: NMT 28oC Read Temp:
Std. RH: NMT 55% Read RH:

Balance calibration done on date:

4.4.1Carry out Moulding operation and Operate Moulding machines as per: SOP. No: HMA/PRD/SOP005-03.

4.4.2 MATERIALS RECONCILLIATION AT INJECTION MOULDING SECTION:

Items Cap Hub Molding

Molding
Unique I.D. No.
Date of Commencement
Date of Completion
Qty. of Virgin Raw Materials used (Kg)
Qty of Re-run added (Kg)
Qty. Of Components Produced (Kg)
Qty. of Re-run Generated (Kg)
Qty. of Waste Generated (Kg)
Percentage Yield
Done by: Production Executive
Sign & Date:
 HMA MEDICAL LIMITED Page 6 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:
 HMA MEDICAL LIMITED Page 7 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

4.6 BLISTERING OF ASSEMBLED NEEDLE & SYRINGE

Blistering of Assembled Needle and Syringe was carried out as per: SOP. No HMA/PRD/SOP/013-03

 Required quantities of tested and cleared assembled syringes & needles were obtained from Syringe Assembly and Needle
Assembly respectively.
 There was Check to ensure the blistering machine and its conveyor lines are cleaned and free from blockades.
 The machine was switched on to ensure a boot up the computerized machine user interface control.
 The blistering line was set to the appropriate speed.
 The temperature gauges were checked to ensure the forming mould and sealing mould were appropriately set to the required
temperature.
 Trial run of the blistering operation unit was done to check for the correctness of the output quality in terms of clarity of
batch coding, sealing and batch forming
 The QC was intimated for sampling of the blistered syringe & needle.
 Commenced blistering operation in earnest after receiving approval from the QA.

4.6.1 RECONCILIATION OF MATERIALS AT BLISTERING SECTION:

Syringe Assembled Paper Film
Needle

Unique ID. No

Date of Commencement

Date of Completion

Qty. Received (Kg)

Qty of materials used (Kg)

Qty. Of Components unused

Qty. of Re-useable Generated (Kg)

Qty. of Waste Generated (Kg)

Qty of blistered products sampled (pcs)

Qty of blistered products Produced (pcs)

Percentage Yield

Done by: Production Executive Checked by: Production Manager Verified by: QA Executive

Sign & Date: Sign & Date: Sign & date

5 PRODUCTION FLOW CHART FOR SYRINGE & NEEDLE

 HMA MEDICAL LIMITED Page 8 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

Material Unloading Process

De-dusting of material in
dedusting area

Raw Material Packing Material

Under/Test Raw Material Under/Test Packing

QC Check
Material
Approved Raw Material Approved Packaging Material

Material Rejection,
Manufacturing of components (Scrap of Rejection Room),
Barrel, Plunger, Hub, Cap in Run-offs.
moulding machine areas

Component
Cleaning(dedusting) Crushing, mixing of Run-offs

Barrel scale printing on

barrel printing machine

Assembly of Plunger, Barrel

Gasket and Needle on
automatic assembly line
Needle Assembly Process

Primary packing in blister

packing machine in blister Brought out Packaging Material
packaging room

Manual inner Box packing process

in Secondary Packing Room Brought out Packaging Material

Manual outer Box packing process

in Tertiary Packing Room Brought out Packaging Material

Sterilization Process

Quarantine Finish Product

Sample taken for sterility, IP, pyrogen tests
Approved Finish Product

Store in Finish Product store

ready
Ready to Dispatch
 HMA MEDICAL LIMITED Page 9 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

6 QUALITY ASSURANCE PROCEDURES (INSPECTION):

QA performed In-process checks for all manufacturing process as per SOP. No. HMA/QAD/SOP/004-02

6.1 IN-PROCESS CONTROL IN INJECTION MOULDING

Name of parts: Barrel Plunger Cap Hub

Material Used: Polypropylene Polyethylene Polypropylene Polypropylene

Material: Lot No: Lot No: Lot No: Lot No:

Unique ID. No Unique ID. No Unique ID. No Unique ID. No Unique ID. No

Batch Size Batch Size: Batch Size: Batch Size: Batch Size:

M/C ID:

TEST DESCRIPTION OBSERVATIONS REMARKS

VISUAL TEST BARREL PLUNGER CAP HUB
Appearance
Dust/foreign particles
Pin hole
Blockage
Flash
Short Pcs
Shrinkage
Weird dot, Dent mark
Body Scratch line
Position of Nozzle
Leakage From Gate Point
Leakage From Nozzle
PHYSICAL & FUNCTIONAL TEST
Syringe Nozzle conical Fitting
Deformations test
Lock Test
Air bubble
Weight of component (g)
Length of component (mm)
Dead space (g)
Width (mm)
External diameter (mm)
Wall thickness (mm)
Component Blockage
Colour
Done By: IPQC Sign & Date Checked by QC Executive Sign & Date

Verified By Quality Control Manager: Sign & Date

 HMA MEDICAL LIMITED Page 10 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

6.2 IN-PROCESS CONTROL IN PRINTING & SYRINGE ASSEMBLY UNIT

Date: Print Ink Lot No: 609 Aid Lot No:

Product: Gasket Lot No: Hexane Lot No:
Operator: Silicon Lot No: Toluene Lot No:
Unique ID. No Pack Product: Batch Size:
M/C ID: Operator:
TEST DESCRIPTION OBSERVATIONS REMARKS
VISUAL TEST PRINTED BARREL ASSEMBLED SYRINGE
Graduation Lines
Dot, Block marks
Printing Clarity
Single Use only Letters
Assembled Pieces without gaskets
Position of Nozzle
Nozzle Taper
Nozzle Tip
Fiducial Line Positioning
Presence of Foreign particles
Sliding Test
Silicon lubrication
Syringe damage (Barrel + Plunger)
Gate point Leakage
Nozzle point Leakage
ANALYTICAL TEST
Leakage Test:
Actuation force Test
Aspiration Test
DIMENSIONS
VOLUME VERIFICATION
Syringe Size Syringe Maximum Minimum overall length Scale Increment between Maximum Tolerance on
Avg. wt./pc Dead Space of scale to Nominal Interval Graduation lines to Usable Nominal
Capacity be numbered Capacity Capacity

Done By: IPQC Sign & Date

Checked By: QC EXECUTIVE Sign & Date
 HMA MEDICAL LIMITED Page 11 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

Verified By: QC MANAGER Sign & Date

6.3 BLISTER PACKING SECTION IN PROCESS CHECK REPORT
Date: Mfd: Printing Ink Lot No
Product: Exp: Thinner Lot No:
Unique ID. No Film Lot No: IC box Lot No:
Batch Size: Paper Lot No: MC box Lot No:
Paper Avg,wt./pc: Pack Product: Pack wt.:
M/C ID No: Operator: R/B. Film Avg. wt/pc:

S/No TEST OBSERVATIONS REMARKS

1 VISUAL TEST
2 Pack Sealing
3 Pin hole
4 Batch Printing
5 Foreign Particles
6 Sealing Temperature
7 Damages
8 Blister Leakages
9 DIMENSIONS
1 R/B Film/B.Film.Thickness
2 B,Film/B.paper GSM
3 IC Dimensions/Avg. wt.
4 MC Dimensions/Avg. wt.
Done By: IPQC Sign & Date
Checked By: QC EXECUTIVE Sign & Date
Verified By: QC MANAGER Sign & Date
 HMA MEDICAL LIMITED Page 12 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

7.0 PACKAGING PROCEDURES

7.1 QUALITY ASSURANCE AUTHORIZATION TO PACK

Blistered Syringe and Needle of Unique ID No…………………………… was manufactured and analyzed as per
the standard laid down procedures and specifications and found to comply with specified standards, packing materials
have been analyzed and released by QC and issuance documented by stores before use, and is hereby approved for
commencement of packaging operation.
This is as per the In-Process control reports of: --------------------------- and Date: --------------------------

Q.C: Executive _____________________________ Date: __________________

Q.C. Manager: _____________________________ Date: ___________________

Production Record Checked by: Approval for packing by:

(Production Manager) (QUALITY ASSURANCE. Manager)

Sign/Date Sign/Date

7.2 ISSUANCE OF PACKING MATERIALS:

SR. Name of the Packing UOM Std. AR.No. Quantity Issued by: Checked Verified
Material(s) Issued Store by: Prod. by QC
No. Qty.

1 Inner carton Nos

2 Corrugated printed Outer Nos

cartons

3 Tape Kg

Issuance Done by Store Officer: Checked by: Packaging Supervisor Verified by: QC Executive
(Sign and Date) (Sign and Date) (Sign and Date)

7.3 Line Clearance – Packing as per SOP No.: HMA/PRD/SOP004-03

Previous Product Unique ID. No

Check List Done by (Production) Verified by

(Q.C)

Area Cleanliness (Floor, walls, ceiling).

Check the cleanliness of the packing line.

Ensure absence of materials from previous product batch.

Ensure proper batch of product are brought in from assembly line

Ensure all proper materials for packing are available &are as per specification.
 HMA MEDICAL LIMITED Page 13 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

Ensure the inner and the outer carton are properly coded and approved by the Q.C
before packing.

7.4 PACKAGING

Time Started: Time Finished:

Step Activity Done by: (Production) Checked by (Q.C)

1. Clean the packing line table with a wet clean cloth moist
with 70% IPA solution

2. Visual inspection: Observe for any suspended matter

3. Syringe and needle blistered set cleaning: Ensure all syringe

and needle blistered set are cleaned

4. Finally pack in an inner Box in a row of …. blistered pieces

of……. sets (i.e…….blistered of…….sets). …… inner
boxes are arranged in……decks by…. rows,
totaling………. syringe and needle blistered sets per outer
carton. Seal with Starch paste bond/adhesive tape

5. Stack the outer cartons in the pre-sterilization goods’ store

quarantine on the pallets off the walls while awaiting
sterilization.

6. Reconcile the packing materials & Yield

7.4.1 BATCH RECONCILIATION SHEET FOR COMPONENT PACKING

BATCH RECONCILIATION
QUANTITY BLISTERED SET INNER CARTON SHIPPER CARTON
A. Qty. received

Qty. packed
Qty. sampled
Qty. rejected
Qty. returned
Qty. retained with BMR

Qty. retained by QC Retention Sample

B. Total Qty. used

(B/A) X 100 = % Yield
Remarks: Give justification for any higher % rejection

If rejection is high due to manufacturers defect, then inform manufacturer through the General Manager. Destroy the
material after being checked by QC with the athorization of the General Manager after approval by the QA manager
in the presence of QA Executive.

Checked by: Destruction Recommended Approved Quality Assurance Authorized by:

QC Officer: by QCM Manager GM:
 HMA MEDICAL LIMITED Page 14 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

Sr. No. 1 2 3 4 5 Total Qty.

Date:

Qty. transferred:
Shippers + Loss

Transferred by

Received by

7.4.2 TRANSFER TO STERILIZATION CHAMBER

8.0 LABELLING PROCEDURES

8.1 INNER AND SHIPPER CARTONS CODING

CODING INSTRUCTION: Inner and shipper cartons was coded as per SOP. No. HMA/QAD/SOP/006-04 and
HMA/PRD/SOP21/00

NOTE: Inner and Shipper Carton Coding: First & last coded inner and shipper cartons were checked, approved
& signed by production Manager & Q.C. Manager

9.0 STERILIZATION PROCEDURE

9.1Line Clearance – Sterilization Chamber: SOP No.: HMA/PRD/SOP004-03, HMA/PRD/SOP015-00

Previous Product: UNIQUE ID. NO:

Check List Checked by (Production) Verified by (QC)

Area Cleanliness (floor, walls, ceiling).

Check the cleanliness of the Autoclave

Ensure absence of materials from Previous product/batch

Chemical / Biological Indicators paper is in place

 HMA MEDICAL LIMITED Page 15 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

9.2 TERMINAL STERILISATION BY ETHYLENE OXIDE GAS SOP No.: HMA/PRD/SOP016-03

Time
Steps Particulars Done By Checked By
From To

1 Outer cartons containing blistered syringe and needle sets in

inner cartons were arranged in the sterilization Chamber so as to
occupy not more than 80% of the entire volume of the chamber

2 Biological-chemical indicators were inserted at strategic

locations where access of gas is most remote according to the
earlier mapping of the chamber’s inner space

3 The door of the sterilizing chamber was closed pneumatically

after loading the products

4 Sterilization parameters for the batch were set at following

conditions-
* Sterilization Temp.: 56oC
* Chamber Pressure: -48kPa to -50kPa
* Sterilization time: 5 hours.

5 Sterilization period

6 Cycle period

7 After completion of sterilization cycle, off -loading was done

and the sterilized syringe and needle blistered sets in shipper
cartons were arranged on packing pallets.

8 Chemical-biological indicator was checked by Operator in charge & Q.C. Officer and attached to DHR

Sterilization:

Done By Checked By Verified By

Operator: Production Supervisor: Q.C. Executive:

 HMA MEDICAL LIMITED Page 16 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

Product description: Unique ID. No Machine no: Date

Retention sample: Total pack quantity:

10.0 FINAL BATCH RECONCILLATION

Components Material Unique ID. Received Rejected Returned Quantity
code No Quantity Quantity and return no

Barrel
Plunger
Hub
Cap
Printed barrel
Assembled syringe
Assembled needle
Cannula
Blistered set
PVC Film
Dialyzing Paper
Inner Carton
Sealing Tape
Shipper Carton
E O gas

11.0 POST STERILIZATION INSPECTION AND TESTING

Sterilized products were relocated from the sterilization unit and to the quarantine until the batch has been tested for
sterility by the QC laboratory (Microbiology) for 14 days incubation period. The batch was checked to verify the
product and quantities sent to the sterilizer have been relocated and reconciled. The chemical change indicator tape
was verified.
11.1 Intimate Quality Control of completion & Sampling.
Intimation Given by______________ Time: ______________Date: ________________

11.2 Sampling Details:

Sampled Quantity: _____________________

Sampling Done by: _____________________

Time: _________ Date: __________________

12.0 INSPECTION AND RELEASE PROCEDURES

The Physicochemical, Pyrogen and Sterility Tests were performed. Sterility test was done and monitored for 14days
incubation period while the products were in quarantine. The product was released when it has passed the
Physicochemical, Pyrogen and Sterility Tests. Release of product shall be as per SOP No.: HMA/QAD/SOP007-03
 HMA MEDICAL LIMITED Page 17 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.:

12.1 DEVIATION APPROVAL SHEET

DEVIATION REASON AND JUSTIFICATION PROPOSED BY. REVIEWED BY: APPROVED BY:
(QCM) (QAM)

AUTHORIZED
BY: (GM)

12.2 BATCH REVIEW

Release certificate No: Date:

Product
Unique ID No.
Manufacturing Date
Expiry Date
In process Analytical Report No. & AR status
Finished product Analytical report No & AR status
Qty. Packed and released for Sale
(Shippers carton + Loss)

Batch Document Enclosures:

Chemical-Biological Indicator
Certificate of analysis
Empty batch coded pouch of blistered set Start
Confirmation of retention Sample Units of …………………….

This is to certify that the batch has been manufactured and packed as per the laid down standard procedures & all
documents have been Verified.

Production Manager Q.C Manager

Sign/Date: Sign/Date:

BATCH RELEASE APPROVED BY:

The documents are verified and the batch found to comply with BP/NIS 2020 specifications, in-house specification
and duly released for Sale and distribution.

Quality Assurance Manager: ________________________ Sign/Date: __________________

 HMA MEDICAL LIMITED Page 18 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
PRODUCT:
UNIQUE ID NO: DHR NO.:
DHR REVISION NO.: