COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

PRODUCT X

FILL SIZE x mL

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

CERTIFICATION

CERTIFICATE OF QUALITY ASSURANCE THIS IS TO CERTIFY THAT THE BATCH No. _______OF PRODUCT X (TRADE NAME _______), SATISFIES THE REGULATORY AND PHARMACOPOEIAL REQUIREMENTS FOR PRODUCT X VACCINE. Signature of Quality Assurance: Date :

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

1. BATCH RECORD REVIEW AND APPROVAL REPORT

No Term Details 1 Name of the Product PRODUCT X 2 Batch No. 3 Date of Filling 4 Quantity Filled 5 Quantity Released 6 Mfg. Date 7 Exp. Date

Reviewed by QA (Analyst/Officer): Approved by Head QA: Date: Date: 2. CHECKLIST OF BATCH RECORD:

Signature of Supervisor: Signature of Quality Assurance: Date: Date :

Document availability checked by No Description

Date Production QA

1 Product X Vaccine Blending 2 Primary packing materials

procurement

3 Washing and sterilization of vials, stoppers and vessels.

4 Sterilization of filling items 5 Filling 6 Filling particulars 7 Recording of deviations 8 Primary packing materials

reconciliation record

9 Visual Inspection 11 Packing details for shipment to NCL 12 Finished goods transfer note to NCL

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

3. QUALITY CONTROL REPORTS AND MISCELLANEOUS DOCUMENTS CHECK LIST:

Availability checked by No Name of the Report Q.C Ref.No.

Production QA 1 Formulation buffer 2 Final Blend report (1) 3 Final Blend report (2) 4 Filled vials report (1) 5 Filled vials report (2) 6 Thermo graphs of Autoclave NA 7 Vials Depyrogenation report NA 8 Membrane Integrity report NA 9 Environmental monitoring report NA

10 Particle count report NA 11 NCL report NA 12 WFI report of blending port NA 13 WFI report of washing port NA

Signature of Supervisor: Signature of Quality Assurance: Date: Date :

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

4. Product X VACCINE BLENDING: 4.1 Volume of blend: _____ Liters. 4.2 Details of blending materials:

Description of material Lot No / B. No Q.C. Ref No. Assay (mg/mL)

A) Bulk antigen (xx mg/mL) (SOP # ___/ Spec # ___)

B) Formulation solution #1 (xx mg/mL) (SOP #_____)

C) Formulation solution #2 (xx mg/mL) (SOP # ____)

Signature of Supervisor: Date : 4.3 Bulk antigen requirement for blend: 4.3.1 Antigen requirement: Calculate the antigen requirement for the blend as per SOP # _______

Blend volume in mL (A) Total antigen required in mg (A x XX) / 1000 4.3.2 Details of antigen: Lot No. of Bulk

Q.C. Ref No. and Date

Antigen concentration in mg/mL (A)

Volume in mL (B)

Total antigen in mg A x B As mentioned above

Total volume Total rounded off to Signature of Supervisor: Date :

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

4.4 Solution #1 (FS#1) requirement for the blend: 4.4.1 Solution #1 (FS#1) requirement: Calculate Formulation Solution #1 requirement for the blend as per SOP # ______

Blend volume in mL Total XXXX required in mg (Blend volume x XX mg/mL)

4.4.2 Details of Formulation Solution #1 (FS#1)

No. Batch No. Q.C. Ref. No. and Date

FS#1 content (mg/mL)

(A)

Volume in mL (B)

Total FS#1 in (mg) (A x B)

as mentioned above Total volume Total round off to Signature of Supervisor: Date: 4.5 Requirement of Formulation Solution #2(FS#2) for the blend: 4.5.1 Formulation Solution # (FS#2) requirement: Refer SOPs# _____________

Blend volume In (mL)

A

Total Bulk Volume (mL) B

Total FS#1 Volume (mL) C

Required quantity of FS#2 (mL) D = A- (B+C)

4.5.2 Blending vessel Particulars:

1 Type of vessel XXX liter blending vessel 2 Make XXX 3 ID.No. ####### 4 Cleaned by 5 SIP cycle No / Load No 6. LAFU Validation Done on: Due on: Line clearance given by QA

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

4.5.3 Details of blending : Ingredient Temp of

vessel oC Spec.

oC/ % Volume added

Added by

Checked by Date

FS#1 as per 4.4.1 xx to xx oC FS#2 as per 4.5.1 xx to xx oC

Bulk antigen as per 4.3.1

xx to xx oC

Stirring (%) xx – xx % Stirring start time: ___________. End time: __________ (stirring time specifications: X to X hrs) Signature of Supervisor : Signature of Quality Assurance : Date : Date : 4.6 Final blend sampling details: For sample collection, labeling, storage details refer SOP# _________ Sampled Quantity

Sampled by

Date and Time

Tests to be done SOP.No/ Spec No

Q.C.Ref. No. and

Date

Report Date

Description pH XXX content XXX content Bacterial Endotoxins (LAL)

Sterility XXX

xx mL

Potency

Signature of Supervisor : Signature of Quality Assurance : Date : Date :

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

5. PRIMARY PACKING MATERIALS PROCUREMENT:

Checked by No Name of material

Spec.No. AR.No Quantity required

Quantity issued

by store

Quantity received Production

supervisor Q.A. in charge

1 X mL vials 2 xx mm grey

butyl stoppers

3 xx mm aluminium seals

Remarks (if any) : Signature of Supervisor : Signature of Quality Assurance : Date : Date :

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

6. WASHING AND STERILIZATION OF STOPPERS AND FILLING ITEMS: 6.1 Stoppers details: Size: xx mm Colour: grey butyl 6.1.1 Machine particulars: Name of the machine: STOPPER WASHING MACHINE I.D. No. xxxxxx Validation Done on: Due on: Cleaned by Checked by LAFU I.D. No: Validation Due on:

6.1.2 Treatment of stoppers: Treatment procedure of stoppers as per SOP # ________ 6.1.2.1 Quantity of treatment solution (TS#1) required for stoppers:

Total volume of WFI (mL) (A)

Total TS#1 required in mg at XX mg/mL (A x XX)

6.1.2.2 Details of TS#1 treatment: (Final TS#1 concentration should be xx mg/mL) No Ingredient STP.No./

Spec.No. A.R. No. Qty

Required Qty weighed

Weighed by

Checked by

1 TS#1 xxx mg 2 WFI NA xxxx mL

Volume of TS#1 solution prepared

Volume of TS#1 solution used

Volume of TS#1 solution discarded

Excess TS#1 solution discarded by: Checked by: TS#1 treatment of stoppers done by: Date Checked by: Date:

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

6.1.3 20 mm Grey butyl rubber Stopper washing particulars: Stopper washing, WFI inspection procedure refer SOP # ______ 6.1.3.1 Drain water of Stopper washing machine checked by___________ 6.1.3.2 Lot No—I Washing details:

Washing No Date Operator involved

in washing Start Time

End Time Qty

Washed. Final rinse drain

water inspected by

1st rinse 2nd rinse 3rd rinse

Details of Stopper Collection into S.S cans for Stopper Lot No I:

Thiomersal solution

Can No

Date S.S can cleaned by

No. of stoppers collected

Collected by

Volume added

Added by

Checked by

Repeat as necessary for as many lots of Stoppers that are required 6.1.4 Sterilization of stoppers: Sterilization procedure of stoppers and sterilization by autoclave refer SOP # ________. 6.1.4.1 Equipment particulars: Name of the Machine and Make AUTOCLAVE XXXXXXX I.D. No. ####### Validation Done on: Due on: Cleaned by: Checked by: 6.1.4.2 Details of stopper sterilization as per load pattern No : 1 Date Load

No. Can No

Qty Loaded by

Sterilization temp

Sterilization time

Specification Un-loaded by

xx min at

XX oC

Signature of Supervisor : Date:

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

6.2 Details of filling accessories sterilization as per load pattern No 2 Washing and sterilization of filling accessories refer SOP# _______ Date Load

No. Items Qty Washed

& Loaded

by

Sterilizat-ion temp

Sterilizat-ion time

Specific'n Un-loaded

by

Checked by

Filling sets with glass syringes

#

Stopper Bowl

#

Chute # Picker wheel

#

Section wheel

#

Glass syringes

#

Forceps # Silicon tubes

#

20 L pressure vessel

#

SS tray #

xx min at XX oC

Signature of Supervisor : Date:

6.3 Details of garments, gloves and wipes sterilization as per load pattern No 3 Date Load

No. Items Qty Loaded

by Sterilization

temp Sterilization

time Specific-

ation Un-

loaded by

Checked by

Garments Gloves Wipes

Mask

xx min

at XX oC

Signature of Supervisor : Date:

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

6.4 Fumigation of blending and filling area: Fumigating procedure refer SOP# ___________

Time Area Date Formaldehyde Quantity

WFI Quantity

Fumigation done by

From To

Check-ed by

Signature of Supervisor : Date: Signature of QA: Date:

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

7. WASHING AND DEPYROGENATION OF VIALS. 7.1 Washing of vials : Vial washing, inspection and depyrogenation procedure as per SOP #______. 7.1.1 Machine particulars: Equipment Name: XXXXXXXX Make XXXXXXX ID.No. ########### Validation Done on: Due on: Cleaned by Checked by: Parameter Results Air pressure: (Spec x to x Kg/cm2 )

Water pressure: (Spec x to x Kg/cm2 )

Final rinsing WFI Temperature: (Spec xx to xx oC)

Flow of water in all needles Flow of air in all needles Checked by Date & Time Signature of Supervisor : Date : 7.1.2 Vial washing particulars : LAFU I.D. No: ############# Validation Due on:

Time of washing Date WFI sample inspected by Start

Time End Time

Vials loaded

by

Washing machine

operated by

Total No. of vials Washed

No. of vials

broken Total

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

7.1.3 Washed vials inspection (For particles) : ( Frequency every x hours)

Date Time Checked by Remarks

Signature of Supervisor : Date :

7.2 Depyrogenation of vials: 7.2.1 Machine particulars: Equipment Name and Make XXXXXXX I.D. No. ######## Validation Done on: Due on: Cleaned by: Checked by:

7.2.2 Depyrogenation Details :

Depyrog'n Date Tunnel start time

Set Temp

OC

Temp OC (> X)

Time Min. (≥ x)

Tunnel stop time

Tunnel Drive

mm/min

Temp monitored

by

Depyrog'n data

enclosed Yes/no

Checked by

Quantity depyrog'd

Heater 1 Heater 2 Heater 3 Heater 4

< xxx

Signature of Supervisor : Date :

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

8 . FILLING PARTICULARS: 8.1 Filling line clearance : line clearance as per SOP# ____________ LAFU I.D. No: ######### Validation Due on: 8.1.1 Machine particulars and line clearance details:

Equipment Name Filling Machine Stoppering Machine Sealing Machine Make XXXXX XXXXX XXXXX I.D. No. ######## ######## ######## Room No. Validation done on Validation due on Cleaned by Checked by

Checked by Verified by QA Sterilization indicators on stoppers, filling items, garments etc Filling area cleanliness Fumigation details Line clearance for filling given by QA:

8.2 Filling operation particulars: 8.2.1 Filling Operation: Filling operation refer SOP #____________ 8.2.2 Filling Operation Details:

Date Time Filling Machine operator

Stoppering Machine operator

Sealing Machine operator

Filled vials collected by

Signature of Prod. Shift incharge

Signature of QA. Shift incharge

Signature of Supervisor : Date :

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

8.3 Final blend stirring: (Frequency of checking - Every x hour) Stirring and temperature of vessel as per SOP# _______________

Checked by Date Time Stirring (%) Specification (%) Production QA

xx - xx

Signature of Supervisor : Date :

8.4 Volume variation check during filling : 8.4.1 Filling operation: Filling operations, start up activities refer to SOP # ____ and to annex for fill volume standards. Volume variations action limits refer SOP# ______ 8.4.2 Volume check up Details : ( Frequency every x to x hours) Filling Date: Starting time: Closing time:

Pack Size X mL Syringe used for vol. Measurement: X mL Fill Volume Specification

xx.x – xx.x mL

Calibration due on:

Volume drawn

No Date Time Nozzle No-1

Nozzle No-2

Nozzle No-3

Nozzle No-4

Nozzle No-5

Nozzle No-6

Checked by

Remarks

Start up volume checks in (mL) 1 2 3

In process Volume checks during filling in (mL) 1 2 3 4 5 6 7

Signature of Supervisor : Date :

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

8.5 Filling area monitoring : ( Frequency every x hours) Filling Date: Starting time: Pack size: X mL Closing time:

Date Time Temp (oC)

Spec (oC)

Humidity (%)

Spec (%)

Checked by

xx to xx oC

xx to xx%

Signature of Supervisor : Date : 8.6 Recording of Interferences/deviations during filling: Deviation action limits and procedures followed refer SOP# ____________ Note: This is the provision to record online interferences during filling if any. Possible deviations: power failure, temperature out of specification, stirring of blend out of specification, Fill volume out of specification, equipment problems etc. Crate

No Date Time Description of

Interference/Deviation Recorded

By Checked

by Deviation report

No. if any Note: This table helps to trace those vials that could have been filled during interferences.(if filled during interferences) Signature of Supervisor : Date :

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

8.7 Filled vials sampling details for QC: Collection of samples Refer SOP# _________ and for Number of samples Refer SOP ________ Date Sampled

Quantity Sampled by QA

Tests to be done S.O.P./ Spec No.

Q.C. Ref. No and Date

Description Identity pH XX content XX content Abnormal toxicity on guinea pigs

Abnormal toxicity on mice Report Date Sterility Bacterial endotoxins (LAL test) Potency

xx Vials

Closure integrity test

Report checked by Prod. Date: Report verified by QA Date: Signature of Supervisor : Signature of Quality Assurance : Date: Date : 8.8 Calculation of practical yield :

Total Process Loss (B)

Theoretical Yield (A) = Batch Vol.÷

Filling Vol

Description Volume in ml

Equivalent vials

Filled Quantity

(C)

No. of samples for

Q.C. Testing (D)

Quantity transferred to Visual inspection E = C- D

a) Sampled Quantity of final blend

b) No. of volume checked vials

c) Vol. discarded after breaks

d) Dead Volume Total (B)

Process Loss (%) = B X 100/A

xx

Checked by Prod. Date: Verified by QA Date:

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

9. PRIMARY PACKING MATERIALS RECONCILIATION:

Process loss Name of Material

Quantity issued

Total Quantity used

Quantity Returned to stores

Quantity % Spec (%)

XX mL Vials ≤ x Stoppers

xx mm grey butyl ≤ x

Seals xx mm ≤ x REMARKS (if any): Signature of Supervisor : Signature of Quality Assurance : Date : Date : 10.MATERIAL RETURN NOTE: 10.1 Material Return Note Number : 10.2 Material Return Details :

No Item code Description AR No. Indent No.

Units Quantity Reason for Returning

REMARKS (if any): Returned By : Approved By : Received By : Signature of Supervisor : Signature of Quality Assurance : Date : Date :

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

11. VISUAL INSPECTION OF VIALS : 11.1 Line clearance for visual inspection : refer Line clearance SOP# ________________ 11.1.1 Cleaning of visual inspection area: Cleaning procedure refer SOP # ______________ Area cleaned by: Checked by: Date: Date : 11.1.2 Line Clearance Details :

Previous product

Present product

No

Batch No.

Pack size

Batch No.

Pack size

Previous product material cleared off from the area Yes /No

Checked. By

Line clearance given by QA

Date Time

Signature of Supervisor : Signature of Quality Assurance : Date : Date :

11.2 Reconciliation of vials after Visual inspection :refer SOP# _____________ 11.2.1 Quantity Received for Visual inspection: _____________________ 11.2.2 Reconciliation Details :

Time Rejected vials as per possible defects No Date

From To

Tested by

Checked by

Passed Quantity random checked

by

Passed Quantity Less

volume (A)

Glass pieces

(B)

Other particles

(C)

Cap Closures defects

(D)

Total (A+B+C+D)

1 2 3 4

Total rejected Quantity Total Passed Quantity % rejection

Specification of optical rejection: ≤ x %

11.2.3 Good Quantity transferred to labeling after Visual inspection:______________ Signature of Supervisor : Signature of Quality Assurance : Date : Date :

COMPANY A Doc.No.# BMR/XX/XX/XX MFR Ref. No.# MFR/XX/XX Title: BATCH MANUFACTURING RECORD FOR PRODUCT X , x mL

BLENDING AND FILLING Batch No. Date of Manufacture: Expiry Date:

Signatures: Effective Date: _______ Written by: Date: Revision number: _____ Reviewed by: Date: Approved by Q.A.: Date:

12. DISCARD NOTE: Destruction

Supervised by Date Item Quantity Reasons

for destruction

Destruction approved

by Destroyed

by Production QA Formulation

Solutions

Glass Vials xx mm stoppers xx mm flip top seals Visual inspection

rejections

Signature of Supervisor : Signature of Quality Assurance : Date : Date : 13. BATCH ACCOUNT: 13.1 Details of batch account: 1 Theoretical yield 2 Filled quantity (b) 3 No. of vials given for Q.C + other samples 4 No. of vials given for visual inspection 5 Total Optical rejections + breakages during optical

testing (e)

6 Passed quantity after Visual inspection. 7 No. of vials packed and sent to NCL 8 Net percentage Yield = (b - e X100)/b 9 Quantity remaining to be labeled and packed. 13.2 Batch packing details: P.R.No.

Date Breakages Quantity

Packed No. of

Samples Quantity

Transferred Quantity

remaining 1 2 3 4 5

Total Signature of Supervisor : Signature of Quality Assurance : Date : Date :