Ceftriaxone 1g Injection

WNSFEILD PHARMACEUTICALS
DOCUMENT #: ISSUED STATUS: ISSUED On:

WNS/QA/BMR/ 1 01-03-2017
INJ/001
QUALITY ASSURANCE DEPARTMENT
BATCH MANUFACTURING RECORD
Product Name: ___Axon 1 g Injection__________ Batch No. _____________________

Batch Size: _____ _____MFG. Date:_______________ EXP Date:_____________
Start Date:______________ Completion Date: ____________ Theoretical Yield:_____________
Pack Size:____1’s_______ Commercial: _____ _____ Physician Sample:_____ _________
Mfg. Lic. No.:_____________ Reg. No.: _____________

BMR Issuance Number:_________________ BMR Issuance Date:_________________
Prepared By: Checked By: Approved By:
Production Manager Quality Control Manager Quality Assurance Manager
PRODUCT DESCRIPTION
White to off white color powder filled in 10 cc

vial with rubber stopper and Yellow color flip
Appearance
off seal.
Primary Packaging Transparent colorless 10 cc glass vial
Packaging
Secondary Packaging Label, Leaflet and Bleech Card Unit Carton
Presentation (Commercial Pack) 1’s
Presentation (P/S) 1’s
Instructions:
a) All documents must be completely and clearly filled in, signed & dated by the
concerned personnel.
b) Any correction(s) or changes must only be crossed with a line (exp. corllection
correction) and initiated and dated. Overwriting and Use of Blanco / whitener are
prohibited.
c) Any observation(s) or suggestion(s) at any stage must be written overleaf.
d) All the relevant documents (s) associated with the production of the batch should be
attached with this BMR.
e) Copying of this document in whole or part is strictly prohibited.
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Batch Manufacturing Order (BMO)
Product Name: Axon 1 Injection Issuance Date:
Batch No Batch Size
Mfg. Date. Exp. Date
Standard Quantity Q.C. No Weight By QAI

S# Ingredients Unit
Quantity Issued
Ceftriaxone (As
1 Kg
Sodium)
Note:
In case of potency adjustment of active ingredient, the quantity of diluents should be adjusted according to the target wt.
S# Water For Injection Unit Quantity Per Batch Quantity Issued Q.C. No
Batch No:
1 Mfg. Date:
Exp. Date:
Checked By (Manger Quality Control): ____________________________________
Requested By Checked By Material Issued Material Received Approved By

Production Quality Control By By Production Production
Pharmacist Manager Ware House Pharmacist Manager
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Batch Manufacturing Order (BMO)
Product Name: Axon 1 Injection Issuance Date:
Batch No Batch Size
Standard Quantity Q.C. No Weight By QAI

S# Ingredients Unit
Quantity Issued
Ceftriaxone (As
1 Kg
Sodium)
Note:
In case of potency adjustment of active ingredient, the quantity of diluents should be adjusted according to the target wt.
S# Water For Injection Unit Quantity Per Batch Quantity Issued Q.C. No
Batch No:
1 Mfg. Date:
Exp. Date:
Requested By Checked By Material Issued Material Received Approved By

Production Quality Control By By Production Production
Pharmacist Manager Ware House Pharmacist Manager
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Batch Packing Order (BPO)
Product Name: Axon 1g Injection Issuance Date:

Batch No Batch Size
Quantity Issued Q.C. No

S# Material(s) Unit Quantity Per Batch
1 Unit Carton Nos
Nos
2 Label
Nos
3 Leaflet
Nos
4 F/O Seal (Green)
Nos
5 Rubber Stopper
Nos
6 Glass Vials 10cc
Nos
7 Master Carton
Nos
8 Pasting Tape
Requested By Material Issued By Checked By Approved By

Production Pharmacist Ware House Quality Control Manager Production Manager
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Batch Packing Order (BPO)
Product Name: Axon 1g Injection Issuance Date:

Batch No Batch Size
Quantity Issued Q.C. No

S# Material(s) Unit Quantity Per Batch
1 Unit Carton Nos
Nos
2 Label
Nos
3 Leaflet
Nos
4 F/O Seal (Green)
Nos
5 Rubber Stopper
Nos
6 Glass Vials 10cc
Nos
7 Master Carton
Nos
8 Pasting Tape
Requested By Material Issued By Checked By Approved By

Production Pharmacist Ware House Quality Control Manager Production Manager
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INJ/001
CERTIFICATE OF ANALYSIS – RO WATER
R.O Water for washing purpose is sent to Q.C Department for testing along with request for
analysis.
Sample
Sample Size Collection Date Collected By Sent to QC
100 ml
Specification Reference: In-House
S.NO PARAMETERS SPECIFICATIONS RESULTS

Clear, color less and odorless
01 Physical Appearance
liquid
02 PH 5.0 – 7.0
-1
03 Conductivity NMT 5 µS.cm
04 Chlorides - ve
05 Sulphates - ve
06 Calcium - ve
07 Magnesium - ve
08 T.D.S NMT 4 ppm
Remarks:
Released For Washing Rejected
Q.C Officer/ Analyst Manager Q.A. / Q.C.
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CERTIFICATE OF ANALYSIS – RO WATER
R.O Water for washing purpose is sent to Q.C Department for testing along with request for
analysis.
Sample
100 ml

Clear, color less and odorless
liquid
02 PH 5.0 – 7.0
03 Conductivity NMT 5 µS.cm-1
04 Chlorides - ve
05 Sulphates - ve
06 Calcium - ve
07 Magnesium - ve
08 T.D.S NMT 4 ppm
Remarks:
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CERTIFICATE OF ANALYSIS – DISTILLED WATER
Distilled Water for washing purpose is sent to Q.C Department for testing along with request
for analysis.
Sample
100 ml

Clear, color less and
odorless liquid
02 PH 5.0 – 7.0
04 Chlorides - ve
05 Sulphates - ve
06 Calcium - ve
07 Magnesium - ve
08 T.D.S NMT 2 ppm
Remarks:
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CERTIFICATE OF ANALYSIS – DISTILLED WATER
Distilled Water for washing purpose is sent to Q.C Department for testing along with request
for analysis.
Sample
100 ml

Clear, color less and
odorless liquid
02 PH 5.0 – 7.0
04 Chlorides - ve
05 Sulphates - ve
06 Calcium - ve
07 Magnesium - ve
08 T.D.S NMT 2 ppm
Remarks:
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Step 1. Pre – Washing GMP Checks
Area cleaning and status checks
 Before starting washing ensure that:

 Washing area is clean & clear from the remains of previous product.
Previous Product Batch No
 Related documents of the product to be are properly filled and available.

 Quantities of the glass vials, rubber stopper and aluminum seal have been checked to be
Correct as per Packing Order.
 Glass vials, rubber stoppers, and aluminum seals have been released by quality control department
 Air conditioning system is working properly and dry temperature not exceeding 25C.
 Labels on glass vials, rubber stoppers and aluminum seals to be washed have been checked
for correct material and lot no.
Production Officer Date / Time Q.A. Officer Date / Time
Line Clearance
Equipment / Machine cleaning & status check
 Equipment / Machine (washing machine, S.S trays, filters, sink etc.) to be used for washing are clean
and clear from the remains of previous product.

0 0
In the water storage tank temperature should be between (70 C to 80 C).
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Step 2. Washing of Glass Vials, Rubber Stoppers, Aluminum Seal’s Washing
Glass vials Date Operator Supervised By

 On receiving the packing order the vials
De-cartooned in the decartoning room and load in
the SS trays.
 Turn On LFH at least 15 minutes before start of
Washing.
 Wash the vials with distilled water and the
Temperature of the should be between
o o
(70 C –80 C ) and pressure should not be
Less than 20 psi.
 Load the glass vials inertly in the washed SS
Trays.
 Perform all the activity under the laminar flow.
 Pressure and temperature in different intervals
Washing Start Time Washing Complete Time Total Time
Total Number of vials rejected during

Washing
Rubber Stoppers Washing Date Operator Supervised By

 Take about 5 liters of distilled water in a S.S bucket
And add 50 g of sodium pyrophosphate.
 After about half an hour, when the salt is
Completely dissolved, soak the rubber stoppers in
This solution and leave for half an hour.
 Rinse the stoppers with distilled water 2---3 times
And ensure that there are no more traces of
Sodium pyrophosphate.
 Put the washed rubber stoppers in a SS container
And wrap in aluminum foil.
Washing Start Time Washing Complete Time Total Time
Total Number of Stoppers rejected during

Washing.
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Aluminum Seals Washing Date Operator Supervised By

 Take aluminum seals in SS bucket, rinse
thoroughly with distilled water pack in SS
container and wrap in aluminum foil.
Washing Start Washing Complete Time Total Time
Time
Total Number of seals rejected during

Washing
Step 3. Sterilization of vials Date Operator Supervised by

 Before starting the sterilization wash the dryer from inner
 and outer side thoroughly with distilled water using lint
free duster.
 Mope the dryer with IPA (70 %) internally.
 Wash the trolleys with distilled water and clean with
IPA (70 %).
 Check the equipment for proper cleaning.
 Load the trays containing washed vials into the trolleys.
 Insert the “thermolog strips” (three Thermolog strips at top,
mid, and bottom. Used Thermolog strip should be attached here.
TOP MIDDLE BOTTOM
Temperature Checked by Checked by

Time after 30 minutes Q.A Officer Production Officer

o
Set the temperature controller to the 230 C
 Turn “ON” the dryer and view for normal setting.
 Turn the dryer ”OFF” after one and half hour by
noting the time and temperature.
 Disconnect the “POWER SUPPLY” and leave the vials in the
dryer to be cooled down to the room temperature.
Sterilization cycle Sterilization cycle Total Time
Start Time Complete Time
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Step 4. Autoclavation (steam sterilization) Date Operator Supervised By

 Before starting the sterilization wash the autoclave
from inner and outer side thoroughly with distilled
water using lint free duster.
 Mope the chamber of Autoclave with IPA (70 %) internally.
 Wash the trolleys with distilled water and clean
with IPA (70 %).
 Check the equipment for the proper cleaning.
 Load the containers containing washed rubber
stoppers, aluminum seals and uniforms.
 Insert the “thermo log” (three
thermo log strips as top, mid, and bottom
 Turn “ON” the power of autoclave.
 Open the “Steam Valve” and note the pressure (The
pressure must NLT 15 psi and NMT25 psi).
 Maintain the pressure for half hour to complete the
sterilization time.
 Shut down the steam and autoclave.
Autoclavation cycle Autoclavation cycle Total Time
Start Time Stop Time
Step 5. Sterilization of active through UV lights Date Operator Supervised By

 Thoroughly clean the containers with IPA.
 Expose the Raw material under the high intensity UV light
for over / more than 12 hours.
( Ensure that the door of the pass through is properly closed.)
Material Exposed Material Exposed Total Time
Start time Complete Time
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Step 6. Pre – Filling GMP checks
Area cleaning and status checks

 Prior to the start of the work ensure that the vials filling area and equipment are clean and area report from the
Q.C is satisfactory.
 Relative humidity should not exceed 40 % and temperature not be more than 25 C
o
Throughout the filling process.

 Before entering into the sterile area make sure that the UV lights have been switched off.
 Personnel working in the sterile area must wear the designated sterile area uniform.
 Personnel entering into the sterile area must possess sound health, and should sign
Health Performa. They should take dettol bath before entering the sterile area and should not be suffering from
common cold and any other Respiratory infection, Bronchitis, sore throat, skin infections rashes, opens wounds, or
skin abrasions, eye infections, diarrhea or stomach upset.
Production Officer Date / Time
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Step 7. Sterile Area Monitoring Report
No. Area Monitored Limit Result

1 Powder Filling Room
A Laminar Flow hood Less than 3 CFU/M3
B Center of the Room Less than 3 CFU/M3
C Particle Count (0.5 µm) NMT 100 Particle/FT3
2 Vials Sealing Room
A Center of the table Less than 3 CFU/M3
3 Change Room
A De Gowning Less than 10 CFU/M3
B Gowning Less than 10 CFU/M3
C Buffer Less than 5 CFU/M3
4 Cooling Room Less than 3 CFU/M3
5 Pass Through Less than 3 CFU/M3
Remarks:
Area Released For Filling Rejected
Microbiologist Manager Q.A. / Q.C.
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No. Area Monitored Limit Result

3 Change Room
Remarks:
Area Released For Filling Rejected
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Step 8. Analytical Report (Before filling)
1. Send request for analysis to Quality Control Department for Physical, Chemical, Sterility and
Pyrogen test of Vials.
2. After release received from Quality Control Department proceed for filling.
Request For Analysis
Product: Axon 1g Injection Batch No:_____________ Bach Size: ___________
Stage: Filling Mfg. Date:_____________ Exp Date:____________
Date:____________________ Time: _________________ Section Incharge:_____
Specification
Sample Size Collection Date Collected By Sent to Qc QC No
Reference
USP
No Parameter Standard Result

1 DESCRIPTION White to off white color powder
2 IDENTIFICATION Must be +ve for Ceftriaxone
3 WATER CONTENT 8.0 – 11.0 %
4 PH 6.0 – 8.0
NMT 0.2 per mg USP Endotoxin
5 B.E.T Unit per mg of Ceftriaxone.
Complies as per USP 35
6 STERILITY TEST requirements
7 ASSAY 90 – 115 %
Remarks:
Released For Filling Rejected
Released Average Weight / Vial ±
QC Officer / Analyst Manager Q.A. / Q.C.
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Step 8. Analytical Report (Before filling)
Pyrogen test of Vials.
2. After release received from Quality Control Department proceed for filling.
Stage: Filling Mfg. Date:_____________ Exp Date:____________
Specification
Reference
USP

4 PH 6.0 – 8.0
7 ASSAY 90 – 115 %
Remarks:
Released For Filling Rejected
Released Average Weight / Vial ±
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Step 9. Vials Filling Date Operator Supervised By

 Before starting the operation, clean the filling
Machine with moist, lint free duster. Duster
Should be moistened with IPA 70%.
 Check the positive pressure in the following area
 Filling Room Std:-__________Actual:-__________
 Sealing Room Std:-__________Actual:-________
 Change Room Std:-__________Actual:-________
 Calibrate the electronic balance with standard
weight.
 Load the empty vials in the turn table.
 Start the filing machine and adjust the
weights according to the pre define standard.
 Weigh the contents of 5 vials and record on
the log sheet.
 Send minimum of 5 vial to the Q.C for weight
variation check.
 After taking the report from Q.C. , start filling
and check weights after regular interval of 30
minutes.
 Seal 20 to 30 vials and check the sealing.
 Send at least 10 vials to Q.C for sealing quality
Check.
Filling Start Time Filling Complete Time Total Time
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Step 10. In process Control Form (Vials filling)
Product:_____Axon 1g Injection___ U.L.: _______________________________

Batch No:_________________________ OBJ: _______________________________
B. Size:___________________________ L..L: _______________________________
Machine: Vial Filling
Operator:__________________________ Date:_____________________________
Time 1 2 3 4 5 Av.Weight R.H. Temp. Production Q.A.I
Media Plate Media Plate

Exposure Exposure Total Time Date Operator Supervised By
Start Time Stop Time
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Area Monitored Limit Result

No.
3 Change Room
Remarks:
Area is Cleared Rejected
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Area Monitored Limit Result

No.
3 Change Room
Remarks:
Area is Cleared Rejected
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Step 12. Analytical Report (Filled Vials)
Pyrogen test of Filled Vials.
2. After release received from Quality Control Department proceed for Labelling.
Stage: Labelling Mfg. Date:_____________ Exp Date:____________
Specification
Reference
USP

4 PH 6.0 – 8.0
PARTICULATE Meets the requirements for SV
6 Injections.
MATTER
8 ASSAY 90 – 115 %
Remarks:
Released For Labelling Rejected
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Step 12. Analytical Report (Filled Vials)
Pyrogen test of Filled Vials.
2. After release received from Quality Control Department proceed for Labelling.
Stage: Labelling Mfg. Date:_____________ Exp Date:____________
Specification
Reference
USP

4 PH 6.0 – 8.0
6 Injections.
MATTER
8 ASSAY 90 – 115 %
Remarks:
Released For Labelling Rejected
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Step 13. Cleaning, Mopping and Fumigation of Date Operator Supervised By

the Sterile Area
 Mop the whole Sterile Area with disinfectant solution.
The disinfectant solution are 70% IPA or 5% Phenol
solution alternatively.
 Clean the filling machine and sealing machine with 70 %
IPA.
 Fumigate the filling and sealing area by the preparation
of the fumigation solutions, Take about 1 to 2 gram of
KmnO4 in the petridish and add about 10 ml of formalin solution.
Cleaning Start Time Cleaning Stop Time Total Time
Line Clearance For Optical Checking

 Ensure that the optical section are clean and clear from the remains of previous product.
 Containers for storage of vials, rejected vials, checked vials are properly identified and identification
slip properly pasted.
 Ensure that Temperature and RH of the area and record in T/RH monitoring sheet.
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Step 14. Vials Optical Checking Date Operator Supervised By
 Total Number of vials produced after filling.
_____________________________________
 Total Number of Vials Rejected during Optical
Checking.
_____________________________________
 Total No. of vials produced after the optical

Checking.
____________________________________________
Optical Checking Optical Checking Total Time

Start Time Complete Time
PACKAGING
Line Clearance For Over Printing
 Ensure that the printing section is clean and clear from the remains of previous product.
 Containers for printed and unprinted packaging components are properly identified and identification
slip properly pasted.
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Step 15. Over Printing Record
Product Over-Printing
Matter to be printed on Label & U/C for Injection
Product: Axon 1 g Injection
Batch No.:
Item: Label / Unit Carton Mfg. Date:
Quantity: Exp. Date:
Details on Ampoule of WFI
Production Officer:
WFI Batch No.:
WFI Mfg Date: Pre Printed Ampoules
Q.A. Officer:
WFI Exp. Date:
Date Item Qty. Issued By Printed By Checked By

Unit Cartons
Labels
Sample’s Cartons & label attached backside of the paper.
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Step 16. Pre-Packaging GMP Checks
Area cleaning and status check

 Before starting Packaging ensure that ,
The packaging area is clean and cleared from the remains of previous products.
 Product to be packed is properly identified and approval has been taken from
the Q. A. Department.
 Conveyer belt is clean and cleared from the remains of previous product.
 All packaging components have been verified and cross checked as per the
quantity mentioned in the packing order.
 Related documents of the product to be packed are available on the belt.
Equipment / Machine cleaning & status check

 All equipment required for packing i.e. Conveyer Belts, are clean and cleared
from the remains of previous product.
UC & Label Sorting
Date Item Qty. Issued By Printed By Checked By

Unit Cartons
Labels
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Step 17. Packaging Line Control Sheet
Product Over-Printing
Product: Axon 1g Injection
Batch No.:
Commercial Mfg. Date:
Packing: P/S
Exp. Date:
Belt Incharge: WFI Batch No.
Production Officer Available: Pre-Printed
WFI Mfg. Date: Ampoules
Yes No
WFI Expiry Date:
Equipment / Operation clearance
Previous Product: Clearance Granted
Batch No.:
Ensure that there should not
be any remains of the previous batch. ____________ _____________ __________
Q.A. Officer Time Date
Date:
Time:
Batch No.
Label
Mfg. Date
Exp. Date
Batch No.
Unit Carton
Mfg. Date
Exp. Date
M.R.P. Rs.
Leaflet Available (Y/N)
Units Packed
Master Carton
Batch No.
Mfg. Date
Exp. Date
QC Retains Sample 08 Samples Taken By:
Packing Pharmacist
QAI
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Step 21. FINISHED PRODUCT TRANSFER SLIP
Product: Axon 1g Injection Batch No.:

Packing: P/S Exp. Date:
Quantity Transfer
Date Commercial / PS No of M/C Loose Packs Total Packs
(a) (b) (a+b)
Total Packs Transferred
Packing Production Quality Assurance Ware House

Incharge Manager Manager Incharge
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Step 21. FINISHED PRODUCT TRANSFER SLIP
Product: Axon 1g Injection Batch No.:

Packing: P/S Exp. Date:
Quantity Transfer
Date Commercial / PS No of M/C Loose Packs Total Packs
(a) (b) (a+b)
Total Packs Transferred
Packing Production Quality Assurance Ware House

Incharge Manager Manager Incharge
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Step 18. Reconciliation Sheet (SALE)
Product: ________________Axon 1 g Injection ______________________________

Batch No.:__________________________Batch Size: ____________________________
Presentation: 1’ S Packing Order #.: ______________________
S.# Items Units Quantity Total Rejection Allowable Limit Qty. Supplier
Received Used Unit % age Of Wastage Returned Rejection
1. R. Stoppers No. 3%
2. Flip Off Seal No. 5%
3. Glass vials No. 2%

4. Labels No. 3%
5. Unit Cartons No. 2%
6. Leaflets No. 2%
7. Shippers No. 1%
Supplementary Materials:
_________________________________________________________________________
_________________________________________________________________________
Step 19 Disposal / Destruction of Excess / Rejected Material
Product: _________________Axon 1 g Injection _____________________________

Batch No.:__________________________Batch Size: ___________________________
S.No Item(s) Unit Rejected %age Remarks
1. Rubber Stoppers No.
2. Flip Off Seal No.

3. Glass vials No.
4. Labels No.
5. Unit Cartons No.

6. Leaflets No.
Production Officer WHI Production Manager
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Step 18. Reconciliation Sheet (SALE)
Product: ________________Axon 1 g Injection ______________________________

Batch No.:__________________________Batch Size: ____________________________
S.# Items Units Quantity Total Rejection Allowable Limit Qty. Supplier
Received Used Unit % age Of Wastage Returned Rejection
1. R. Stoppers No. 3%
2. Flip Off Seal No. 5%
3. Glass vials No. 2%

4. Labels No. 3%
5. Unit Cartons No. 2%
6. Leaflets No. 2%
7. Shippers No. 1%
Supplementary Materials:
_________________________________________________________________________
_________________________________________________________________________
Step 19 Disposal / Destruction of Excess / Rejected Material
Product: _________________Axon 1 g Injection _____________________________

Batch No.:__________________________Batch Size: ___________________________
S.No Item(s) Unit Rejected %age Remarks
1. Rubber Stoppers No.
2. Flip Off Seal No.

3. Glass vials No.
4. Labels No.
5. Unit Cartons No.

6. Leaflets No.
Production Officer WHI Production Manager
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Step 20. Yield Statement
Product: _______Axon 1g Injection____ Mfg. Started:

Batch No.: Mfg. Completed:
Batch Size: Packing Started:
Presentation: 1’s Packing Completed:
Manufacturing
Powder Dispense Powder Used Variance (C) Reworking % Loss Total % Remarks
(A) (B) (A-B) (Kg) Left
OPTICAL CHECKING:
Objective Fill Weight of Vials (D): _________________________________________
Actual Fill Weight of Vials (E): _______________ Limit: - __________________

Vials Reject During the Optical Checking In-process QC Samples QC Sample for Sterility, Chemical and
(F) (G) Weight Analysis (H)
PACKING:
Packing (Sales)
Total Qty. Packed In-process QC Sample (J) Total Unit
(I) (G+H) (I+J)
Packing (P/S)
Total Qty. Packed In-process QA Sample Total Unit
(K) (L) (K+L)
Net unit transferred to the FGWH sales (I): _______________________________
Net unit transferred to the FGWH P/S (K): ________________________________
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Sales
Actual yield Actual Yield x 100
Theoretical Yield
P/S
Actual yield Actual Yield x 100
Theoretical Yield
Total Yield % Sale Yield + PS Yield
Limit: + 3%
Production Officer Production Manager Q.C Manager
Remarks: ---------------------------------------------------------------------------------------------------------
Director Operation
Step 21. Re-workable Recovered material Date Operator Supervised By

Give detail of reworking left.
S. No. Product Unit Quantity B. No.
1 Kg
2 Kg
3 Kg
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Step 22. Finished Goods Delivery Note

Date: _____________
Product: _____________________________________________________________________
Batch No.: ____________________________ Batch Size: ____________________________
Mfg. Date: ____________________________ Exp. Date: ____________________________
Qty. Deliver to Store (Sales): ______________________________________Units
Qty. Deliver to Store (P/S): ________________________________________Units
Delivered By: Received By:

Production Officer Warehouse Officer
Step 22. Finished Goods Delivery Note

Date: _____________
Product: _____________________________________________________________________
Batch No.: ____________________________ Batch Size: ____________________________
Mfg. Date: ____________________________ Exp. Date: ____________________________
Qty. Deliver to Store (Sales): ______________________________________Units
Qty. Deliver to Store (P/S): ________________________________________Units
Delivered By: Received By:

Production Officer Warehouse Officer
Page 36 of 40
WNS/QA/BMR/ 1 01-03-2017
INJ/001
Step 23. Analytical Report (Final Product)
Pyrogen test of Final Product.
2. After release received from Quality Control Department proceed for Marketing.
Stage: Final Product Mfg. Date:_____________ Exp Date:____________
Specification
Reference
USP

4 PH 6.0 – 8.0
6 Injections.
MATTER
8 ASSAY 90 – 115 %
Remarks:
Released For Marketing Rejected
Page 37 of 40
WNS/QA/BMR/ 1 01-03-2017
INJ/001
Step 23. Analytical Report (Final Product)
Pyrogen test of Final Product.
2. After release received from Quality Control Department proceed for Marketing.
Stage: Final Product Mfg. Date:_____________ Exp Date:____________
Specification
Reference
USP

4 PH 6.0 – 8.0
6 Injections.
MATTER
8 ASSAY 90 – 115 %
Remarks:
Released For Marketing Rejected
Page 38 of 40
WNS/QA/BMR/ 1 01-03-2017
INJ/001
Step 24. Sterility Test Report (Final Product)
Product _____________________________ Q.C#___________________________
Batch #______________________________ Batch Size______________________
Date Received_________________________ Analysis Date____________________
Mfg Date______________________________ Exp. Date_______________________
Days Date Fluid Thioglycolate Medium Soybean Casein Digest Medium

1 +ve -ve +ve -ve
2 +ve -ve +ve -ve
3 +ve -ve +ve -ve
4 +ve -ve +ve -ve
5 +ve -ve +ve -ve
6 +ve -ve +ve -ve
7 +ve -ve +ve -ve
8 +ve -ve +ve -ve
9 +ve -ve +ve -ve
10 +ve -ve +ve -ve
11 +ve -ve +ve -ve
12 +ve -ve +ve -ve
13 +ve -ve +ve -ve
14 +ve -ve +ve -ve
Observation
Positive Control
Negative Control
Remarks:_____________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
Page 39 of 40
WNS/QA/BMR/ 1 01-03-2017
INJ/001
Step 24. Sterility Test Report (Final Product)
Product _____________________________ Q.C#___________________________
Batch #______________________________ Batch Size______________________
Date Received_________________________ Analysis Date____________________
Mfg Date______________________________ Exp. Date_______________________
Days Date Fluid Thioglycolate Medium Soybean Casein Digest Medium

1 +ve -ve +ve -ve
2 +ve -ve +ve -ve
3 +ve -ve +ve -ve
4 +ve -ve +ve -ve
5 +ve -ve +ve -ve
6 +ve -ve +ve -ve
7 +ve -ve +ve -ve
8 +ve -ve +ve -ve
9 +ve -ve +ve -ve
10 +ve -ve +ve -ve
11 +ve -ve +ve -ve
12 +ve -ve +ve -ve
13 +ve -ve +ve -ve
14 +ve -ve +ve -ve
Observation
Positive Control
Negative Control
Remarks:_____________________________________________________________
________________________________________________________________________
________________________________________________________________________
Page 40 of 40

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WNSFEILD PHARMACEUTICALS

DOCUMENT #: ISSUED STATUS: ISSUED On:

BATCH MANUFACTURING RECORD

BATCH MANUFACTURING RECORD

Product Name: ___Axon 1 g Injection__________ Batch No. _____________________

Start Date:______________ Completion Date: ____________ Theoretical Yield:_____________

Pack Size:____1’s_______ Commercial: _____ _____ Physician Sample:_____ _________

Mfg. Lic. No.:_____________ Reg. No.: _____________

Prepared By: Checked By: Approved By:

Production Manager Quality Control Manager Quality Assurance Manager

White to off white color powder filled in 10 cc

Presentation (Commercial Pack) 1’s

Presentation (P/S) 1’s

BATCH MANUFACTURING RECORD

Batch Manufacturing Order (BMO)

Product Name: Axon 1 Injection Issuance Date:

Batch No Batch Size

Mfg. Date. Exp. Date

Standard Quantity Q.C. No Weight By QAI

Checked By (Manger Quality Control): ____________________________________

Requested By Checked By Material Issued Material Received Approved By

BATCH MANUFACTURING RECORD

Batch Manufacturing Order (BMO)

Product Name: Axon 1 Injection Issuance Date:

Batch No Batch Size

Mfg. Date. Exp. Date

Standard Quantity Q.C. No Weight By QAI

Checked By (Manger Quality Control): ____________________________________

Requested By Checked By Material Issued Material Received Approved By

BATCH MANUFACTURING RECORD

Batch Packing Order (BPO)

Product Name: Axon 1g Injection Issuance Date:

Quantity Issued Q.C. No

1 Unit Carton Nos

Checked By (Manger Quality Control): ____________________________________

Requested By Material Issued By Checked By Approved By

BATCH MANUFACTURING RECORD

Batch Packing Order (BPO)

Product Name: Axon 1g Injection Issuance Date:

Quantity Issued Q.C. No

1 Unit Carton Nos

Checked By (Manger Quality Control): ____________________________________

Requested By Material Issued By Checked By Approved By

BATCH MANUFACTURING RECORD

CERTIFICATE OF ANALYSIS – RO WATER

Sample Size Collection Date Collected By Sent to QC

Specification Reference: In-House

S.NO PARAMETERS SPECIFICATIONS RESULTS

08 T.D.S NMT 4 ppm

Q.C Officer/ Analyst Manager Q.A. / Q.C.

BATCH MANUFACTURING RECORD

CERTIFICATE OF ANALYSIS – RO WATER

Sample Size Collection Date Collected By Sent to QC

Specification Reference: In-House

S.NO PARAMETERS SPECIFICATIONS RESULTS

08 T.D.S NMT 4 ppm

Q.C Officer/ Analyst Manager Q.A. / Q.C.

BATCH MANUFACTURING RECORD

CERTIFICATE OF ANALYSIS – DISTILLED WATER

Sample Size Collection Date Collected By Sent to QC

Specification Reference: In-House

S.NO PARAMETERS SPECIFICATIONS RESULTS

08 T.D.S NMT 2 ppm

Q.C Officer/ Analyst Manager Q.A. / Q.C.

Product Name: _Axon 1 g Injection Batch No. _____________

Start Date:__ Completion Date: Theoretical Yield:_

Pack Size:1’s_ Commercial: _ _ Physician Sample:_ _______

Mfg. Lic. No.:_ Reg. No.: _

Product: Axon 1g Injection Batch No:___ Bach Size: _

Stage: Filling Mfg. Date:_ Exp Date:

Date:________ Time: _ Section Incharge:_

Product: Axon 1g Injection Batch No:___ Bach Size: _

Stage: Filling Mfg. Date:_ Exp Date:

Date:________ Time: _ Section Incharge:_

Product:___Axon 1g Injection_ U.L.: _______________________________