Cefazolin Sodium for Injection 1000 mg

Cefazolin Sodium for Injection 1000mg

GENERAL INSTRUCTIONS:

Good manufacturing practices should be followed during the entire process of

manufacturing including sampling and dispensing.

All the containers and equipment used for manufacturing shall be properly cleaned

as per the relevant SOP of the current version.

All the equipment and containers should have a proper status label with the Product name,

Batch No., Mfg. Date, Exp. Date., etc.

All the equipment should be operated as per the relevant current version SOPs only.

All the measuring equipment and containers should be calibrated irrespective of the

activity and use within the date of calibration as per the calibration schedule.

Weights of all the materials should be cross-checked by production personnel against

dispensing labels and dispensing sheets before being taken up for manufacturing.

Overwriting in BPR shall be strictly avoided.

All the activities should be carried out according to the respective BPR only.

All the operations shall be carried out in a clean and orderly manner.

Any deviation in the process shall be brought to the knowledge of the QA In charge

and prior approval of the QA In charge should be taken.

Critical parameters like temperature, Relative Humidity, and pressure differences

should be checked and monitored during all manufacturing stages.

In-process controls should be carried out throughout manufacturing operations

as per relevant BPR and relevant current version SOPs.

Ensure that all materials like raw materials, in-process materials, and finished products

should be placed in respective areas with the proper status labels.

Attach additional sheets wherever required.

Attach system-generated data recording sheets wherever applicable.

Gowning should be as per the current version SOP while processing.

Masks and hand gloves should be used during processing.

Check for line clearance, cleanliness of the area, and equipment.

Calibrated weighing scales shall be used while processing.

Attach printouts wherever applicable.

Avoid direct product contact.

In the checklist write OK if complies, not OK if not comply, and write

NA if the step is not applicable.

Do not perform any cleaning activity if the area is under manufacturing process.

LABEL CLAIM :

Each vial contains:

Cefazolin Sodium USP

Eq. to Cefazolin ……………..1000mg

Storage Condition – Store in a cool dry place. Protect from light

Shelf Life – 36 Months
Brand Name
Product Manufactured For
Work Order Number
Batch Size:
Mfg. Date:
Exp. Date:
Market
License No.
Type and Size of Vial
Colour of Vial
M.R.P. (Inclusive of All Taxes)
Final Batch Yield

NUMBER OF PERSONNEL INVOLVED IN BATCH MANUFACTURING:

Note: The person which is involved in the whole process from Dispensing to

Final Packing, enter her/his name, Emp. Code, Department, and Sign and

Date in the below table.

Sr. No.	Name of Personnel	Emp. Code	Department	Sign. / Date
1.

EQUIPMENT DETAILS:

Sr. No.	Equipment Name
1.	Closer Processing System cum HPHV.
2.	Rotary vial washer.
3.	Sterilization and de-pyrogenation tunnel.
4.	Automatic Injectable powder filling machine with rubber Stoppering.
5.	Automatic eight-head vial sealing machine.
6.	Automatic visual vial inspection machine.
7.	Automatic self-adhesive vertical Labeling machine.
8.	Empty vial loading table.
9.	Infeed Conveyor Belt for Rotary Vial Washer.
10.	Infeed Turn Table for Rotary Vial Washer.
11.	Infeed turn Table for Filling.
12.	Movable conveyor belt.
13.	Movable conveyor belt.
14.	Infeed Turn Table for Visual Inspection.
15.	Outfeed Turn Table for Visual Inspection.
16.	Movable conveyor belt.
17.	Dynamic Pass Box.

API CALCULATION:-

Detail of API Stock use for Batch

Sr. No.	Active Ingredients	API Code	Quantity (kg)	A.R Number	Mfg. Date	Exp. Date	Water / LOD (%)	Assay (%)
1.	Cefazolin sodium

Factor Calculation

Mol wt of Cefazolin Sodium:476.5

Mol wt of Cefazolin: 454.5

Factor = 476.5/454.5 = 1.048gm

The calculation for Target Fill Weight:

Quantity required as per AR No. 1 =

Label Claim in gm. X Factor X 100 X 100 X Batch Size in no of vials

Assay X (100 – LOD) X 1000

X 1.048 X 100 X 100 X =____________ Kg.

X (100 –__________ ) X 1000

Required as per AR1 – Stock of AR1 = Required from AR2 as per AR1

____________ Kg. – ___________ Kg. =________ Kg. (Required from AR2 as per AR1)

Required from AR2:

Required from AR2 as per AR1 X Assay of AR1X (100 – LOD of AR1) = _______ Kg

Assay of AR2 X (100 – LOD of AR2)

X X (100 – ) = ____________ Kg

_____________X (100 – ____________)

Required as per AR2 –Stock of AR2 = Required from AR3 as per AR2

_______ Kg. – ______ Kg. =________ Kg. (Required from AR3 as per AR2)

Required from AR3:

Required from AR3 as per AR2 X Assay of AR2X (100 – LOD of AR2) = ______ Kg

Assay of AR3 X (100 – LOD of AR3)

X X (100 – ) = ____________ Kg

_____________X (100 – ____________)

Required as per AR3 –Stock of AR3 = Required from AR4 as per AR3

________ Kg. – ___________ Kg. =________ Kg. (Required from AR4 as per AR3)

Required from AR4:

Required from AR4 as per AR3 X Assay of AR3X (100 – LOD of AR3) = ____________ Kg

Assay of AR4 X (100 – LOD of AR4)

X X (100 – ) = ____________ Kg

_____________X (100 – ____________)

Target Filled weight = [(AR1 + AR2+ AR3+AR4)/Batch size in Numbers] x 1000000

=[( + + + )/________] x1000000 = _______ mg/ vials

LINE CLEARANCE FOR DISPENSING AREA USED FOR RM DISPENSING:

Date		Time
Room ID		Equipment ID
Previous product		Previous Batch no.
Temperature (°C)		Cleaning Type
DP (Limit 5-15 Pa)		RH (%)

Sr. No.	Check List				Observation (Ok or Not Ok and NA)
1.	Area clearance and RLAF working.
2.	Calibration status of weighing balance.
3.	Magnehelic gauge reading of the dispensing booth.
4.	Temperature and Relative Humidity are within the limit.
5.	Requisition Slip check for approval.
6.	Previous product materials shifted to the respective area.
7.	Check all the document completion.
Equipment Cleaning Verification:
Sr. No.	Equipment Name	Equipment ID	Cleaning sop No.	Previous Product
				Product Name		Batch No.
1.	Scoops/spoons
2.	Weighing balance
3.	RLAF
Checked By Warehouse (Sign & Date)			Verified By IPQA (Sign & Date)

Note: Warehouse personnel shall write in the observation column whether OK or

not OK and NA if the step is not applicable and IPQA personnel shall verify the same.

DISPENSING OF RAW MATERIAL :

Material Name

Material Code

Container No.

A.R No.

Gross wt.

(kg)

Tare wt. (kg)

Net wt.

(kg)

Dispensed By WH

(Sign/Date)

Checked By

Production

(Sign/Date)

Verified By IPQA

(Sign/Date)

Note: An intact container shall be issued to production. The detail of Weight verification

shall be verified and written inside the Dispensing and sampling booth present near the

filling area under RLAF. After completion of filling the tare weight and net weight shall

be checked by production and verified by IPQA.

LINE CLEARANCE FOR DISPENSING AREA USED FOR PRIMARY PACKING MATERIAL:

Date		Time
Room ID		Equipment ID
Previous product		Previous Batch no.
Temperature (°C)		Cleaning Type
DP (Limit 5-15 Pa)		RH (%)

Sr. No.	Check List				Observation (Ok or Not Ok and NA)
1.	Area clearance and RLAF working.
2.	Calibration status of weighing balance.
3.	Magnehelic gauge reading of the dispensing booth.
4.	Temperature and Relative Humidity are within the limit.
5.	Requisition Slip check for approval.
6.	Previous product materials shifted to the respective area.
7.	Check all the document completion.
Equipment Cleaning Verification:
Sr. No.	Equipment Name	Equipment ID	Cleaning sop No.	Previous Product
				Product Name		Batch No.
1.	Weighing balance
Checked By Warehouse (Sign & Date)			Verified By IPQA (Sign & Date)

Warehouse personnel shall write in the observation column weather OK or not

OK and NA if the step is Not applicable and IPQA personal shall verify the same.

DISPENSING OF PRIMARY PACKAGING MATERIAL

PACKING MATERIAL REQUISITION SHEET: (Production Copy)

Requisitioned By Prod. (Sign. /Date):_____________________

Batch Size: ____________ (Nos) Date: __________________

Sr. No.	Primary Packing Material	Item code	Unit Nos/Kg	Std. Qty (For 10,000)	A.R. No.	Qty. Issued	Checked By (Prod.)	Verified By (QA)
1.	Vial
2.	Rubber stopper
3.	Flip Off Seal

MANUFACTURING

Instruction:

Ensure all the received shipper have the Approved label has been affixed.

Received Shipper pack of the Vials shall be De- shippered in material Receiving Area (Lift Area)

De-shippered, Vials shrink pack shall keep into the Bottle Loading Area by using Trolley.

Ensure and check for the damaged shrink pack (if any damage shrink pack found returned

it to Warehouse department for replacement).

Load the Vials on Loading table and check for the Defects as per respective SOP ,

Title: Decartoning and empty Vial Inspection, if any Defects are found place them in

to the rejection Bin provided.

Line Clearance Check-list for Vial De-cartoning & Inspection

Check and ensure the cleanliness of area, inspection table & waste bin

Area is free from any remnants of previous activity and batch materials.

Check and ensure that the log book of area and equipment are completed and signed off.

Ensure the type and size of the issued vials

Check and ensure that the quantity of the vials issued is available.

Details on equipment / Containers status labels match with BPR details.

Check and ensure that the status labels in the area are maintained.

Check & ensure that the rejection tray with status is available.

Vial De-cartoning Procedure

De-pack / de-carton the shippers / cartons as per Respective SOP.

Load vials on the inspection table. Inspect the vials visually and pass them to

vial washing machine through swing conveyor.

De-Cartoning And Inspection of Empty Vials Record:

From	To	Quantity rejection						Total rejects
From	To	Molding Defects	Breakage	Crack defect	Spot/shade particle	Size variation	Colour variation	Total rejects

Total Rejection ___________________________

Issued quantity from store – Total Rejection = Total transfer quantity for washing

VIALS WASHING, VIAL STERILIZATION & DE-PYROGENATION

Line Clearance Check-list for Vial Washing

Line properly identified.

Floor and surrounding area neat and clean.

All equipment clean and free from foreign material.

Status Label is filled with current batch details.

Details on equipment / Containers status labels match with BPR details.

Washing nozzles are working properly.

Pump and air pressure of water and air is satisfactory.

Check and ensure the cleanliness of area and Vial Sterilization & Depyrogenation Tunnel

Check and ensure the batch entries (batch no., mfg. date, exp. date, vial type) are correct

as per respective batch.

Check and ensure that the BPR is completed till the activity

Check and ensure that the calibration and validation status of all equipment is within

validity periods

Check and ensure PLC set parameters for the vial type to be sterilized are as per the

required size of vials

Details on equipment / Containers status labels match with BPR details.

Check and ensure that internal cleaning of the tunnel has been done as per the

predefined frequency and no previous product is present.

Check & ensure the DP in the Magnehelic gauge is within the limit

Drying zone	70-120 (Pa)
Sterilizing zone	150-250 (Pa)
Cool zone	70-120 (Pa)
Stabilization	70-120 (Pa)

Equipment Cleaning Verification:
Sr. No.	Equipment Name	Equipment ID	Cleaning SOP	Previous Product
Sr. No.	Equipment Name	Equipment ID	Cleaning SOP	Product Name	Batch No.
1.	Conveyor Linker
2.	Turn Tables
3.	Rotary Vial Washer M/C
4.	Depyrogenation Tunnel

TEMPERATURE AND RELATIVE HUMIDITY RECORD

Date	Time	Temp. (°C) Limit(NMT 25°C)	RH (%) Limit (NMT 55%)	DP in Pascal

LIMIT:

Temperature NMT25°C and Relative Humidity NMT 55% (As Per Area Monitoring SOP).

Temperature and Relative Humidity Should be checked during starting of the activity

and every 2 hours.

Procedure:

After tacking line clearance from IPQA personnel, Start the conveyor linker to charge the

Turn table with vials.

Now start the turntable as speed specified in the BPR (CPP column) and Ensure that

Turn table is at least half loaded with vials.

Check the Vial washer parameter as per point No. 8.3 and ensure the parameter are

within the specified Limit and record the Observation in 8.3 table for initial set-up.

Now Start and Operate the Automatic Rotary Vial Washer machine as per respective

equipment SOP and align the vial with the machine inlet, and start the washing activity.

Now Collect the 06 vials to perform Clarity test, add WFI in vial up to neck and check the

clarity as per point no. 8.5 and record the observation in respected column, (if any rejections

found during the washing Re-Wash the vial and check the clarity, if clarity found OK

continue the process).

After washing, vial shall be go for the sterilization and Depyrogenation process in the tunnel.

Check the Tunnel Parameters as specified in the point No. 8.8 and record the observation

in the respected column.

Vial Washing Parameter initial Set-up:

Time

Purified Water Pressure

WFI Pressure

Re-circulated Water Pressure

Compressed Air Pressure

Limit

1.0-2.0 kg/cm²

Limit

1.0-2.0 kg/cm²

Limit

1.0-2.0 kg/cm²

Limit

1.0-2.5 kg/cm²

VIAL WASHING RECORD

Date

Washing Time

Machine Speed

(Limit: 110-240 Vials/min.)

Wash Qty.

Rejection

(Nos)

From

In process Clarity Checking of Washed Vials

(Frequency: At the start of washing then approx. every 2 hours.)

Date & Time	No. of Vials	Observation						Total Rejection (A+B)
		Fibers	Particles After Reconstitute by WFI		Glass Piece	De shaped vials (A)	Others Damaged (B)
		Fibers	Black	White	Glass Piece	De shaped vials (A)	Others Damaged (B)

Vial Washing Parameter In-process Check

(Frequency: At the start of washing then approx. every 2 hours).

Time

Purified Water Pressure

WFI Pressure

Re-circulated Water Pressure

Compressed Air Pressure

Limit

1.0-2.0 kg/cm²

Limit

1.0-2.0 kg/cm²

Limit

1.0-2.0 kg/cm²

Limit

1.0-2.5 kg/cm²

VIAL STERILIZATION & DEPYROGENATION RECORD

Date

Time

Operated by

(Sign & Date)

Checked by

(Sign & Date)

From

In Process Parameter checks during Sterilization and Depyrogenation:

Frequency: Initial and Approx. Every 1 hour. All the below parameters shall be

checked on the HMI screen of the tunnel.

Time

DP in Pascal (by HMI)

Temperatures in °C

Conveyor Speed

( mm/min)

Drying Zone

(70-120)

Hot Zone (150-250)

Cool Zone/ (70-120)

Stabilization Zone (70-120)

Hot Zone Temp

Limit(320-340°C)

The printed record of Vial Sterilization & Depyrogenation Tunnel to be attached in the BPR.

RUBBER STOPPER (AUTOCLAVE)

Instructions:

Set-up and operate the equipments as per SOP.

Use cleaned and sterilized Container.

Use SS handle to open the door.

Place the washed Rubber Plugs/Bungs to the autoclave, after feeding the

Rubber Plugs/Bungs close the door.

Sterilize the Rubber Plugs/Bungs for 30 minutes at 121.5°C temperature.

Send the rinse water sample to the QC lab

Attach steam indicator chemical strip.

Record the autoclave process in below table and Log Book.

Line Clearance For Rubber Plug/Bung Autoclave Area & Equipment

Check List

Line properly identified.
Floor and surrounding area neat and clean.
All equipment clean and free from foreign material.
Previous product materials shifted to the respective area.
Status Label is filled with current batch details.
Details on equipment / Containers status labels match with BPR details.
Generated steam is pure.

Equipment Cleaning Verification
S. No.	Equipment Name	Equipment ID	Cleaning SOP	Previous Product
				Product Name	Batch No.
1.	Bung Processor Cum HPHV

Rubber stopper washing and Sterilization Record

Sr. No.

Quantity

Washing & Sterilization

Parameter printout

Done by

Operator

(Sign/Date)

Start

End

Attached / Not Attached

Before going to the next step check the steam indicator chemical strip is attached.

FLIP OFF SEAL WASHING AND AUTOCLAVE

Instructions:

Set-up and operate the equipment as per SOP.
Use cleaned and sterilized SS vessels.
Rinse the flip-off / seal twice with purified water.
Finally, wash with WFI.

LINE CLEARANCE FOR FLIP OFF WASHING AREA & EQUIPMENT

Check List

Line properly identified.
Floor and surrounding area neat and clean.
Equipment and accessories are clean and free from foreign material.
Previous product materials shifted to the respective area.
Status Label is filled with current batch details.
Details on equipment / Containers status labels match with BPR details.

Equipment Cleaning Verification
Sr. No.	Equipment Name	Equipment ID	Cleaning SOP	Previous Product
				Product Name	Batch No.
1.	Bung Processor Cum HPHV

FLIP OFF WASHING RECORD

Date	Quantity Taken for Washing	Process Time		Done By (Sign/Date)
		From	To

STERILIZATION OF FLIP-OFF/ SEALS

Instructions:

Set-up and operate the equipments as per SOP.

Use SS handle to open the door.

Place the washed flip off / seal to the autoclave, after feeding the flip off / seal close the door.

Sterilize the flip off / seal for 30 minutes at 121°C temperature.

Record the autoclave process in below table and Log Book.

FLIP OFF SEAL STERILIZATION RECORD

Date

Load Name

Temp.

(°C)

Start time

Sterilization Hold

End Time

Start

End

STERILIZATION OF MACHINE PARTS AND ACCESSORIES (AUTOCLAVE)

Instructions:

Firstly wash the machine parts with hot Purified water, finally, wash with WFI and send

the rinse water sample to QC lab, if the results are satisfactory then send the parts

for sterilization. Attach steam indicator chemical strip.

Machine parts and sterilize in the autoclave at 121.5°C for 30 minutes.

Date

Load Name

Temp.

(°C)

Start time

Sterilization Hold

End Time

Start

End

FILLING AND STOPPERING PROCESS

Line Clearance for Filling, Stoppering

Check List

Line properly identified.

Floor and surrounding area neat and clean.

All equipment clean and free of foreign material.

Previous product materials shifted to the respective area.

All the workers should wear protective cloth, dust mask and gloves while

handling raw materials

Further check the name of the material and CR No. on the label of dispensed material

Respective BPR is available with previous stage completed.

Status Label is filled with current batch details.

Details on equipment / Containers labels match with BPR details.

Rinse Water Result and previous stage QC results.

A.R No.___________________.

LAF working and pressure within limit.

Equipment Cleaning Verification
Sr. No.	Equipment Name	Equipment ID	Cleaning SOP	Previous Product
Sr. No.	Equipment Name	Equipment ID	Cleaning SOP	Product Name	Batch No.
1.	Filling Machine
2.	Stoppering Machine
3.	Analytical Balance
4.	Scoop

Environmental Monitoring: Frequency every 2 hour.

Date	Time	Temp. (°C) Limit (NMT 25°C)	RH (%) Limit (NMT30%)	DP in Pascal

LIMIT: Temperature NMT 25 °C and Relative Humidity NMT 30% (As Per Area

Monitoring SOP). Temperature and Relative Humidity Should be checked during

starting of the activity and every 2 hours.

PRODUCT INPROCESS SPECIFICATION:

S. No.	Parameter	Standard	Limit/Result	Frequency of Check
1.	Appearance	Off White colour powder		Initial Stage
2.	pH	Between 4.0 to 6.0		Initial Stage
3.	Particular Matter Test	Results Should Be Satisfactory		Empty Sealed Vial By Microbiologist
4.	Individual Fill Weight	±3%	To g	Every One Hour alternate by Production and IPQA
5.	Leak Test	Leak Test Should be Pass	100% Pass	Every Two Hours
6.	Temperature	23˚C + 2˚C	21˚C-25˚C	Every Two Hour
7.	Relative Humidity	NMT 30 %	NMT 30%	Every Two Hour

Process:

After taken Line clearance From IPQA personnel, Start the Machine.

On the basis of API Calculation, Set the Standard Individual Fill Weight Variation.

Now Collect the 08 Filled Vials From Each filling Station (Hopper-1 And Hopper-2) and

Check the Fill weight variation on analytical balance.

Ensure the Fill weight of powder shall within the Acceptance Criteria.

Production and IPQA personnel both are Check the individual weight variation at the

time of initial set-up.

After IPQA approval start the filling process.

Check the In-Process parameters as per the given standard Frequency.

IN-PROCESS RECORD DURING FILLING & BUNGING PROCESS

Initial In-Process Weight Variation Check List for Production and IPQA:

Date & Time		Weight Variation Check								Checked By Sign & Date
Date & Time		Head-1	Head-2	Head-3	Head-4	Head-5	Head-6	Head-7	Head-8	Checked By Sign & Date
	H-1
	H-2

Remarks: H-1 (Hopper 1) H-2 (Hopper 2)

After IPQA approval Start the machine

Date

Time:

Speed

Done By

(Sign & Date)

From

In process Checks ( Frequency: Every One Hour alternate by Production and IPQA)

Line Clearance For Vial Sealing Process

Check List

Line properly identified.
Floor and surrounding area neat and clean.
All equipment clean and free of foreign material.
Previous product materials shifted to the respective area.
Respective BPR is available with previous stage completed.
Status Label is Sealing with current batch details.
Details on equipment / Containers labels match with BPR details.
Rinse Water Result and previous stage QC results.
LAF working and pressure within limit.

Equipment Cleaning Verification:
Sr. No.	Equipment Name	Equipment ID	Cleaning SOP	Previous Product
				Product Name	Batch No.
1.	Automatic Vial Sealing Machine
2.	Conveyor Linker

Procedure:

After tacking line clearance from IPQA Start the machine for initial Set-up as per

respective Equipment SOP.

Check and ensure that, the environmental condition within the limit.

Now take 08 Sealed Vials from the sealing machine conveyor and check for the proper sealing.

Now withdrawn 08 vials for the Leak Test sample and perform the leak test for 100 % No Leakage.

After complies of Leak test Start the Sealing activity and Record the Observation.

Initial In-Process Check:

Carry out the sealing of the total no of filled vials as per Respective SOP record

the In-process details below.

Put [√ ] for OK and [ × ] for NOT OK.

Date

Time

Temp. (°c)

(%)

Sealing status from individual heads

In process Checks ( Frequency: Every One Hour alternate by Production and IPQA)

*LIMIT: Temperature NMT 25 °C and Relative Humidity NMT 30% (As Per Area Monitoring SOP

Date

Time

Temp.

(°c)

(%)

Sealing status from individual heads

In process Checks ( Frequency: Every One Hour alternate by Production and IPQA)

LEAK TEST RECORD

Carry out the sealed vials for leak test at a one time by each sealing head (8 vials) as per Respective SOP record the In-process details below as per Respective SOP. Check the leak test, initial and after every two hour by production personnel and verified by IPQA using leak test integrity machine the Leak test shall be 100% No leakage. Record the in process details of leak test in below table.

Date	Time	Leak Test For Filled and Sealed Vials
Date	Time	1	2	3	4	5	6	7	8

FILLED AND SEALED VIALS RECORD

Date	Qty. Filled	Qty. Sealed	Rejection Filled	Rejection Sealed	No. of Trays	Done By

OPTICAL INSPECTION RECORD

Procedure:

After Tacking Line clearance from the IPQA personnel Check and Record

the environmental monitoring.

After Sealing, Inspect the Filled and Sealed vials as per respective Equipment SOP.

If any rejections are found keep them in the rejection bin provided.

Note: One Visual inspector shall perform the inspection activity only for 2 hours.

Checklist

Line properly identified.

Floor and surrounding area neat and clean.

Inspection table is clean and free from foreign material.

Previous product materials shifted to the respective area.

Status Label is filled with current batch details.

Ensure that the checking table light is working properly

Ensure that only qualified workers are doing the optical inspections

Reconstitute the vial with particular solvent as given on product label before

starting and after compilation of optical inspection for clarity.

Equipment Cleaning Verification:
Sr. No.	Equipment Name	Equipment ID	Cleaning SOP	Previous Product
Sr. No.	Equipment Name	Equipment ID	Cleaning SOP	Product Name	Batch No.
1.	Automatic Optical Inspection Machine
2.	Turn Table
3.	Conveyor Linker

Optical Inspection Record:

Date	Inspection Time		Quantity Rejected	Done By Sign/ Date	Checked By Sign/ Date	Verified By Sign/ Date
	Start	End

Optical Rejection Record:

Note: Ensure that one Inspector shall perform inspection activity only for 2 hours.

Date	Name of Inspector	Rejection Record					Total Rejection	Checked By Sign/ Date	Verified By Sign/ Date
		Weight Variation	Sealing	Fiber		Glass Particle
				White	Black

Yield Reconciliation:

Sr. No.	Step	Quantity in Nos	Checked By (Sign & Date)	Verified By (Sign & Date)
A.	Theoretical Batch Size in Nos.
B.	Total Good Inspected Vials transfer for packing
C.	Quantity Withdrawn for Leak test Nos
D.	Quantity withdrawn for QC Sample in Nos.
E.	In process Check in Nos.
F.	Rejection During Filling in Nos.
G.	Rejection During Sealing Nos
H.	Rejection During visual inspection in Nos.
I.	Total Rejection = F+G+H
Batch Yield % = B+C+D+E/A x 100 =

Primary Packing Material Reconciliation:

Sr. No.	Particulate	Vial	Rubber Stopper	Flip Off Seal
1.	Received Quantity from Warehouse
2.	Extra quantity received from Warehouse
3.	Total (1 + 2)
4.	Total Good inspected vials
5.	Quantity withdrawn for QC sample
6.	Quantity withdrawn In-process checks
7.	Quantity withdrawn Leak test
8.	Total Quantity (4+5+6+7)
9.	Total Rejection
10.	Extra Material Returned to warehouse
11.	Net Quantity Used (3-10)

Rejected Material Destruction Record:

Note: Rejected Quantity shall be destroyed in 2% NaOH Solution.

Date

Rejected Quantity (NOS)

Destroyed By

Sign/Date

Checked By

Sign/Date

Verified By

Sign/Date

BATCH TRANSFER DETAILS (For Packing)

Date

Quantity Transfer (NOS)

Transferred By

Received By/Date

Verified By/Date

PACKING PROCESS

Instructions:

All equipment and accessories required for use should be cleaned as per the

current approved Standard Operating Procedure.

All equipment must be properly guarded and earthed.

Ensure that all the dispensed packing materials are checked for the correct identity

on the label and also the Weight prior to use.

The temperature and Relative humidity in the packing area should be maintained.

Necessary preventive measures should be taken to avoid cross-contamination of other products.

Ear plugs/muffs must be worn during working in high-noise areas/operations.

All packing operations must be carried out under the supervision of Competent Technical Staff.

All non-utilizable rejects must be recorded and destroyed as per the current

Standard Operating Procedure.

Line clearance Check List

Cleaning of weighing balance.
Ensure that previous batch material is traced from the Waste bin
Calibration status of weighing balance.
Temperature and Relative Humidity.
Requisition Slip check for approval.
Previous product materials shifted to the respective area.
Check all the document completion.

DISPENSING OF SECONDARY PACKAGING MATERIAL

Material Name	Material Code	Std. Qty. (Nos.)	Issued Qty. (Nos.)	A.R. No.

OVERPRINTING AREA

Instruction

Clean the area and the machine and get the Line clearance from IPQA.

Check the quantity of Label and Cartons received.

The first Printed Label and Carton should be checked by the Packing and Approved by the IPQA.

The approved Label and Cartons have to be attached with the BPR.

After taken approval from IPQA start the overprinting Process.

The rejected Over printed materials should be preserved until the batch packing completes

and after completion it has to be destroyed in presence of IPQA and the same

has to be recorded.

Printed materials should be stored properly in the corrugated boxes/Crates.

Line clearance Check List

Line properly identified.

Floor and surrounding area neat and clean.

All equipment clean and free of foreign material.

Components & Records from previous batch/product removed off the line.

Approved labels pasted on packing material.

Status Label is filled with current batch details.

Respective BPR is available with the previous stage completed.

STANDARD CARTON OVERPRINTING DETAILS:

PARTICULARS		CARTON
Product Name:		NA
Batch No.:
Mfg. Date:
Exp. Date:
M.R.P. (Incl. of All Taxes)		NA
Shipper Configuration:		NA
Manufactured for:		NA
Manufactured By:
Checked By Production:	Verified By QA:

CARTON OVERPRINTING RECORD

Date	Operation		No. of Cartons Printed	No. of Cartons Rejected
	From	To

LABEL OVERPRINTING AREA

LINE CLEARANCE FOR LABEL PRINTING AREA & EQUIPMENT

Line clearance Check List

Line properly identified.

Floor and surrounding area neat and clean.

All equipment clean and free of foreign material.

Components & Records from previous batch/product removed off the line.

Approved labels pasted on packing material.

Status Label is filled with current batch details.

Respective BPR is available with previous stage completed.

LABEL OVERPRINTING RECORD

Date

Operation

No. of Roles Printed

Quantity Printed (NOS)

Quantity Rejected

(NOS)

From

VERIFICATION RECORD OF LABEL, CARTON, AND SHIPPER LABEL

PARTICULARS		LABEL
Product Name:		NA
Batch No.:
Mfg. Date:
Exp. Date:
M.R.P. (Incl. of All Taxes)		NA
Shipper Configuration:		NA
Manufactured for:		NA
Manufactured in By:		NA
Checked By Production:	Verified By QA:

SECONDARY PACKING

Instruction:

Ensure the area and the equipment is clean.

Check whether the dispensed secondary packing materials are according to the packing indent.

Write the Date, Product name, Batch number and the stage of the packing on the display board.

Check for the absence of packing material/product of previously run product.

Get the Line clearance from IPQA to start the secondary packing.

Checks the product/batch details on carton, leaflet and shipper label shall approved by IPQA. The approved carton, leaflet and shipper label have to be attached with the BPR

Randomly open the packed shipper (every two hour) and cross check the quantity.

LINE CLEARANCE FOR SECONDARY PACKING AREA & EQUIPMENT

Line clearance Check List

Area clearance

Cleaning of weighing balance

Calibration status of weighing balance

Next Calibration due date

Room Temperature

Ensure whether all the previous batch-packing materials are removed from the area.

Ensure whether the correct packing materials are brought for packing.

Respective BPR is available with the previous stage completed.

PACKING STYLE AND SHIPPER CONFIGURATION

Each Overprinted carton Contains:

01 labeled vial along with 01 leaflets and 01 WFI ampoule

Such _______ Cartons are in a Sleeve

Such_______ Sleeve are packed in a shipper

Input Secondary Packing Material Verification:

Sr. No.	Material Name	Material Code	Qty. Received. (Nos.)	Unit	A.R. No.

Instruction

Before packing affix the Weight range on Weighing Balance for Weight Variation Limit.

Prepare the Weight limit.

Calculation of weight limits for carton:

Weigh randomly 10 complete filled carton, filled vial, water ampoule, Leaflet, Empty carton.

Find out Minimum & maximum weight all.

Find out the Difference between Minimum / Maximum wt. & average wt of all.

Sr. No	Weight of Empty Carton	Sr. No	Weight of filled Vial
1		1
2		2
3		3
4		4
5		5
6		6
7		7
8		8
9		9
10		10
Avg. wt.		Avg. wt.
Min. wt.		Min. wt.
Max. wt.		Max. wt.

A) Minimum wt. of Carton

= Minimum wt. of Empty carton +(Min. wt. of filled vial +

Min. wt. of water ampoule + Min. wt. of Leaflet) =

A) Maximum wt. of Carton

= Maximum wt. of Empty carton +(Max. wt. of the filled vial

+ Max. wt. of water ampoule + Max. wt. of Leaflet)

SECONDARY PACKING LINE IN-PROCESS CONTROL (Frequency: Every Hour)

Date

Time

Labelling & coding Quality

Cartooning & Coding quality

Sleeve/

Outer Carton quality

Shipper Configuration & tapping

Vial in a Shipper (Nos)

Checked Shipper No.

Checked

Calculation of weight limits for Outer Carton/Sleeve pack/Shipper:

Weigh randomly ______ complete Outer Carton/ Sleeve pack and empty shippers.

Find out Minimum & maximum weight of Outer Carton/ Sleeve pack and empty shippers.

Difference between Minimum / Maximum wt. & average wt of a Outer Carton/

Sleeve pack and Empty shipper.

Sr. No	Weight of filled Outer Carton	Sr. No	Weight of Empty shippers
1		1
2		2
3		3
4		4
5		5
6		6
7		7
8		8
9		9
10		10
Avg. wt.		Avg. wt.
Min. wt.		Min. wt.
Max. wt.		Max. wt.

A) Minimum wt. of Shipper

= Minimum wt. of Empty shippers + (Minimum wt. of filled Outer Carton/

Sleeve X total No. of Outer Carton/ Sleeve in a shipper) =

A) Maximum wt. of Packed Shipper

= Max. wt. of Empty shippers + (Max. wt. of filled Outer Carton/

Sleeve X total No. of Outer Carton/ Sleeve in a shipper) =

PACKING MATERIAL RECONCILIATION:

Sr. No.	Particulars	Label	Carton	WFI	Outer Carton/ Sleeve	Leaflet	Shipper	BOPP Tape
01.	Received quantity
02.	Extra quantity Issued
03.	Total quantity received (1 + 2)
04.	Specimen sample
05.	Quantity packed
06.	Quality Control sample (RS)
07.	Quantity withdrawn for Q.C. Analysis
08.	Qty. withdrawn for IPQA
09.	Total Quantity (4+5+6+7+8)
10.	Total Rejection (Over printing, Defective lock, online etc.)
11.	Extra quantity returned to warehouse
12.	Net Qty. used 3- (10+11)

NOTE: Rejected Label, Carton, WFI, Outer Carton/ Sleeve pack , Shipper,Leaflet

should be defaced before sending for disposal.

Reconciliation of Finished Product

Sr. No.	Particulars	Quantity in Numbers	Sign of Packing officer
01.	Quantity received from Inspection
02.	Quantity packed (Transferred to FGTN)
03.	Quantity used for Q.C. Analysis
04.	Quantity given to QA as reference sample
05.	Rejection
06.	2 + 3 + 4 Packing Yield :——————– X 100 01
07.	2 + 3 + 4 Batch Yield: ——————- X100 Batch size