2-E.BMR Liquid Injection

Document No. WB/PD/SOP/002-E Version No. 000.
Issue Date 25/03/2019 Effective Date 01/04/2019

Department Quality Assurance Supersede New
Title:
Page 1 of 28
Batch Manufacturing Record (Liquid Injection)
1. Detail of Product:
Title of Product
Batch Number
Initiation Date Mfg. Date Exp. Date
Please Pick One type
 Intravenous
 Intramuscular
Tablet Type
 Subcutaneous Type (By Action) Selected Type
 Intradermal 1. General
 Depot 2. Antibiotic
3. Lyophilized
4. Other
Ampoule (ml) Ampoule Color
Flip Off Color Trays/Fixer
Leaflet Unit Carton
Quantity Batch Size No. of Ampoules (App.)
Storage Conditions
2. Product Batch Manufacturing Record Issuance:

I have reviewed the batch record to ensure that the copy is complete, all the data
is reviewed and accordingly.
Issued By: (QA
Department)
_____________________ ________________________
QA Officer (Sign & Date) QA Manager (Sign & Date)
I have reviewed the batch record to ensure that the copy is complete, I am
responsible for the Batch Record following issuance.
Issued To.
______________________ _________________________
Prod. Officer (Sign & Date) Prod. Manager (Sign & Date)
3. Table of Contents:
S.No Topics Page Number
1 Detail of Product: 1
Title:
Page 2 of 28
2 Product Batch Manufacturing Record Issuance: 1
3 Table of Contents 2
4 Referred Document(s): 3
5 Required Equipments: 3
6 Instructions for Production Department 4
7 Dispensing: 6
8 Washing 9
9 Filling Process 14
10 Request for Analysis for Filled Vials 16
11 Certificate of Analysis (COA) 17
12 In-Process Control Form During Ampoules Filling 18
13 Request for Analysis for Filled Vials 19
14 Certificate of Analysis (COA) 20
15 Ampoules Optical Checking 21
16 Batch Packaging Record 22
17 Material for Destruction/Return: 26
18 Yield Statement 27
20 Microbiological Report 28
21 Finished Product Transfer Slip: 28
4. Referred Document(s):
S.No Document No. SOP Title
1.
2.
3.
4.
5.
6.
7.
8.
Title:
Page 3 of 28
9.
10.
11.
5. Required Equipments:
EQUIPMENT DETAILS
TYPE :
MODEL:
CAPACITY:
MANUACTURER:
TAG.NO.:
SOP NO.
TYPE :
MODEL:
CAPACITY:
MANUACTURER:
TAG.NO.:
SOP NO.
TYPE :
MODEL:
CAPACITY:
MANUACTURER:
TAG.NO.:
SOP NO.
TYPE :
MODEL:
CAPACITY:
MANUACTURER:
TAG.NO.:
SOP NO.
TYPE :
MODEL:
CAPACITY:
MANUACTURER:
TAG.NO.:
SOP NO.
6. Instructions for Production Department:

6.1 All documents must be completely and clearly filled in, signed & dated by the concerned personnel.
Title:
Page 4 of 28
6.2 Any correction(s) overwriting or changes must be initialed and dated. Use of Blanco / whiteners is
prohibited. In case of Documentation, must follow the SOP “Good Documentation Practices
(QA/SOP/005)”.
6.3 Before starting washing ensure that:
6.3.1 Washing area is clean & clear from the remains of previous product.
6.3.2 Previous Product:_________________________________ Batch No.______________
6.3.3 Related documents of the product to be are properly filled and available.
6.3.4 Quantities of ampoules have been checked to be correct as per Packing Order.
6.3.5 Heating and Ventilation system is working properly.
6.4 Manufacturing/Process Requirements:

Following are the manufacturing requirements regarding temperature, humidity and Differential
Pressure,
Observation Comply/
Parameters Area Acceptance Criteria
Not Comply
 Solution Preparation/  NMT 24 ºC
Manufacturing Area
 NMT 24 ºC
 Ampoule Washing
Temperature (ºC) room
 Cooling Zone
 NMT 26 ºC
 Ampoule Filling
&Sealing Area  NMT 26 ºC
 Solution Preparation/
 NMT 40 %
Manufacturing Area
Relative Humidity (%)  Cooling Zone
 NMT 45 %
 Ampoule Filling
 NMT 45 %
&Sealing Area
 Ampoule Filling vs.
Ampoule Washing
 Ampoule Filling vs.  NLT 10 Pascals
Cooling Zone
Differential Pressure
 Ampoule Filling vs.  NLT 10 Pascals
(mm/Pascal)
Air Lock
 Solution Preparation/  NLT 10 Pascals
Manufacturing Area
vs. Air Lock
Specifications Regarding Settle Plate Technique:-
Specified Limit Fungal
ISO CLASS US FS 209 E Observations Observations
CFU/Plate Count
5/A & B Class 100 <1 Nil
6/- Class 1000 -- Nil
7/C Class 10,000 05 Nil
8/D Class 100,000 50 Nil
Specifications Regarding Air Sampling:

Microbial Active Air Action Levels
ISO C/Class cGMP Grade (EU
(CFU/mᵌ ) for 1000 Liter of air per Observations
Designation Based)
plate
5/100 A,B ˃1
Title:
Page 5 of 28
6/1000 N/A ˃7
7/10000 C ˃10
8/100000 D ˃100
Specifications Regarding Finger dab Test:
ISO C/Class Designation Fingertip Sample Observations
5/100 >3
7/10000 N/A
8/100000 N/A
Specifications Regarding SWAB Test:
ISO C/Class Designation CFU Observations
5/100 >3
6/1000 N/A
7/10000 >5
8/100000 >100
Specifications Regarding Particle Count (Non-Viable):
ISO CLASS US FS 209 E ISO, mᵌ FS 209E,ftᵌ Observations
5/A Class 100 3520 100
5/B Class 100 3520 100
7/C Class 10,000 352000 10000
8/D Class 100,000 3520000 100,000
Note:
Report must be attached regarding Environmental Monitoring against above mentioned parameters.
7. Dispensing:
7.1 Line Clearance Checks:
Steps Objectives Comments
Environmental Conditions Comply. Obs. Temp.:
7.1.1
Temperature: 20 ºC to 26 ºC & Humidity: 35 to 50% Obs. Humidity.:
Check for the cleanliness of area and record the same in the
7.1.2
checklist
Inspect the dispensing area and thoroughly check for any visible
7.1.3
contamination of previous product as per the checklist.
Recommend rewash, if visible contamination from the previous
7.1.4
product is noticed
7.1.5 All materials from previous operations have been removed
Equipment and accessories from previous operations have been
7.1.6
removed.
7.1.7 Paperwork from previous operations has been removed
The reverse laminar flow booths and surrounding are clean and
7.1.8
status is displayed.
All the equipment and accessories required for dispensing are clean
7.1.9
and record is maintained.
Check that the differential pressure of the area is negative with
7.1.10
respect to the adjacent corridor.
Title:
Page 6 of 28
7.1.11 The RLAF is working properly
7.1.12 The balances are calibrated.
The raw material for the name, batch number, QC Number, Expiry
7.1.13
Date and Retest Dates are OK and Observed.
.
I have confirmed the above stated requirements are fulfilled and the area is clear for
dispensing.
Confirmed By.
______________________ _________________________
QA. Officer (Sign & Date) Warehouse In charge (Sign & Date)
Title:
Page 7 of 28
7.2 Manufacturing Formulae: (Original)
Product Title Batch No.
Batch Quantity Weight (Kg.): No. Of Vials: Fill Weight
Manufacturing Date Expiry Date
Quantity
Factor/ Extra Quantity Per Weighed By Checked By
Item QC. No. Exp. Date Per Unit
Potency (%age) Batch (Kg.) (W. House) (Q.A)
(Mg)
I have confirmed that the above dispensed raw materials actives and in actives are as per approved formulation. Moreover, the
above dispensed quantity is accurate and they are within expiry.
Confirmed
By.
______________________ _________________________ __________________________________
QA. Officer (Sign & Date) Warehouse In charge (Sign & Date) Received By (Prod. Officer) (Sign & Date)
7.3 Manufacturing Formulae : (Warehouse Copy)
Batch Quantity Weight (Kg.): No. Of Vials: Fill Weight
Manufacturing Date Expiry Date
Quantity
Factor/ Extra Quantity Per Weighed By Checked By
Item QC. No. Exp. Date Per Unit
Potency (%age) Batch (Kg.) (W. House) (Q.A)
(Mg)
Title:
Page 8 of 28
I have confirmed that the above dispensed raw materials actives and in actives are as per approved formulation. Moreover, the
above dispensed quantity is accurate and they are within expiry.
Confirmed
By.
______________________ _________________________ __________________________________
QA. Officer (Sign & Date) Warehouse In charge (Sign & Date) Received By (Prod. Officer) (Sign & Date)
Title:
Page 9 of 28
8. Washing
8.1 Washing of Ampoules:
Supervised
Glass Ampoules Washing Process Date Operator
By
Precautions:
Check and make sure that Semi-Automatic Ampoule Filling and
Sealing Machine has been cleaned. Make sure that Line
clearance is duly checked and signed by QA Personal. properly.
Make sure that the filling area has been cleaned
Step-01:
The Ampoules decartoned in the decartoning room and load in
the SS trays.
Step-02:
Turn On LFH at least 15 minutes before start of washing. Switch
on the Laminar flow and make sure that has been wiped with
70% IPA.
Step-03:
Feed the Ampoules to an inclined charging hopper from
Sterilized S.S boxes.
The Ampoules are passed continuously through rotating feeding
wheel, which in turn transfers the Ampoules positively to
Ampoule conveyor by the Charging hopper.
The temperature of the water should be between 70 ºC and
pressure should not be less than 20 psi.
The Ampoule conveyor carries the Ampoules vertically at an
angle of 300.
Step-04:
Pass the nitrogen (Inert Gas) into the empty Ampoules.
Step-05:
Perform all the activity under the laminar flow.
Step-06:
Pressure and temperature in different intervals
Phase/ Cycle-01:
Pressure ____________________ psi.
Temperature_________________ oC
Washer Velocity______________ m/s or Km/hr
Time________________________
Phase/ Cycle-02:
Pressure ____________________ psi.
Temperature_________________ oC
Washer Velocity______________ m/s or Km/hr
Time________________________
Washing Start Washing Complete
Total Time
Time Time
Total Number of Ampoules rejected

during Washing-in Cycle-01
Title:
Page 10 of 28
8.2 Sterile Solution Preparation:

Supervised
Solution Preparation Steps Date Operator
By
Precautions:
Check and make sure that the relevant utensils have been
cleaned and Line clearance is duly checked and signed by QA
Personal. The HVAC system is working properly and calibrated.
The air changes are conformed by Microbiologist and viable and
non-viable particles are examined, report is attached.
Step-01:
prepare the solution as per approved procedure as first add
small quantity of water for injections having temperature NLT 30
ºC and then add the excipients along with active(es) slowly in
small quantities.
Step-02:
After the total dissolution is attained, make final volume of the
container up to the mark with solvent as per required volume.
Stirring Time:____________ Stirring Speed:________________

Soln. Preparation Soln. Prep.
Total Time
Start Time Complete Time
Step-03:
Finally filter the solution with o.2 and
0.45 micron filter paper.
Soln. Filtration Soln. Filtration.
Total Time
8.3 Sterilization of Ampoules:

Supervised
Sterilization of Ampoules Steps Date Operator
By
Title:
Page 11 of 28
Step-01:
Before starting the sterilization wash the dryer is from inner and
outer side thoroughly with distilled water using lint free duster.
Step-02:
Mope the dryer with IPA (70 %) internally.
Step-03:
Wash the trolleys with distilled water and clean with IPA (70 %).
Step-04:
Check the equipment for proper cleaning.
Step-05:
Load the trays containing washed vials into the trolleys.
Step-06:
Program the timer and attach the graph paper on it.
Step-07:
Set the temperature controller to the 220 Co
Step-08:
Maintain the temperature of two and half hours for cycle
completion.
Step-09:
Turn the dryer ”OFF” after two and half hour by noting the time
and temperature on the graph.
Step-10:
Disconnect the “POWER SUPPLY” and leave the Ampoules in
the dryer to be cooled down to the room temperature.
(Sterilization of Ampoules)
(Operation of dry heat Sterilizer)
Machine parts if any sterilize
Total no of Ampoules Sterilized
Sterilization
Sterilization cycle
cycle Start Total Time
Complete Time
Time
8.4 Autoclavation of Utilities:

( Autoclavation) Date Operator Checked By
Title:
Page 12 of 28
Step-01:
Before starting the sterilization wash the autoclave from inner
and outer side thoroughly with distilled water using lint free
duster.
Step-02:
Mope the chamber of Autoclave with 70 %IPA iinternally.
Step-03:
Wash the trolleys with distilled water and clean with IPA (70
%).
Step-04:
Check the equipment for the proper cleaning.
Step-05:
Load the containers containing washed rubber stoppers,
aluminum seals and uniforms.
Step-06:
Turn “ON” the power of autoclave.
Step-07:
Program the timer and attach the graph paper on it.
Step-08:
Open the “Steam Valve” and note the pressure (The pressure
must not be less than 1kg/cm² and not more than 1.5kg/cm).
Step-09:
Maintain the pressure for half hour to complete the sterilization
time.
Step-10:
Shut down the steam and autoclave.
Time------------------- Pressure
Total number of rubber stopper and tear off seal sterilized
Total number of gloves sterilized
Machine parts if any sterilized--------------------
Autoclavation Autoclavation
cycle cycle Total Time
Start Time Stop Time
8.5 Sterilization of Active through Ultra Violet Lights:

Title:
Page 13 of 28
Supervised
Sterilization of Active through UV lights Date Operator
By
Step-01:
Thoroughly clean the containers with IPA .
Step-02:
Expose the raw material under the high intensity UV light
for over / more than 12 hours.
Step-03:
Ensure that the door of the pass through is properly closed.
Total number of container:____________________

Material
Material Exposed
Exposed Total Time
Complete Time
Start time
I have confirmed that the above steps are properly followed and the above data
mentioned is accurate and absolute.
Confirmed By
______________________ _________________________
QA. Officer (Sign & Date) Production Officer (Sign & Date)
Title:
Page 14 of 28
9.0 Filling Process:
9.1 Line Clearance for Powder Filling:
Steps Objectives Comments
Environmental Conditions Comply. Obs. Temp.:
9.1.1
Temperature: 20 ºC to 26 ºC & Humidity: 35 to 50% Obs. Humidity.:
Check the differential pressure of the area is negative as compared

9.1.2
to lower class area. (Partial Pressure: 10 t0 15 Pascal)
Ensure the batch, documents, labels, material, powder, tablets or

9.1.3
remnants of previous product.
9.1.4 Ensure “Cleaned” label is affixed on each equipment.
Recommend rewash, if visible contamination from the previous
9.1.5
product is noticed
9.1.6 Check the wash water analysis report.
For Cleanliness, Check the areas,
1. Uniform of Personnel
2. Air Lock-01, Gowning Room and Buffer
3. Area under Filling/Sealing Machine.
9.1.7 4. Supply Air Grills.
5. Return Air Grills
6. Floor, Walls, Ceiling & Drain
7. Trays
8. Light & Fixtures
9.1.8 Check that the Area monitoring Reports are satisfactory.
Review all applicable GMP Processing Area Logbook(s) and verify
that Cleaning has been performed according to Facility Cleaning
9.1.9
Procedures ( )
Date Cleaning Complete: _____________
9.2 Initial Test before Injection/Ampoule Filling:

S. No. Critical Process Variable Acceptance Criteria Remarks
1. Ampoule Inspection
Must be OK on the basis of cleaning
2. Ampoule Cleaning Status
Report in Distilled Water
Volume of solution to fill
3. while observed on starting
10 Ampoules
4. pH of solution
 Vials should be essentially free
from visible particulate matter.
5. Particulate Matter  Sub Visible Particles Matter:
> 10 μ: NMT 3000/Vial
> 25 μ: NMT 300/Vial
Ampoule Filling vs. Buffer
Buffer vs. Gowning
Differential Partial Gowning vs. Air lock-01
6.
(mm/Pascal) Air Lock-01 vs. Corridor
(Each Area have NLT 10 Pascals
Differential Pressure)
Title:
Page 15 of 28
9.3 List of Personnel in Area:

S.NO. Name Designation Responsibility
Washing
1.
2.
3.
4.
Solution Preparation
5.
6.
Sealing
7.
8.
9.
I have confirmed that the above steps are properly followed and the above data
mentioned is accurate and absolute.
Confirmed By
______________________ _________________________
QA. Officer (Sign & Date) Production Officer (Sign & Date)
10.0 Request for Analysis for Solution for Injection:

Document No. QC/SOP/004-C Version No. 000.
Title: Request of Analysis (Purified Water/Water
Page 15 of 28
for Injection, in-Process/ Finished Products)
A. TO BE FILLED BY PRODUCTION DEPARTMENT
Title:
Department Section
Dosage Type Stage
Title:
Page 16 of 28
Formula No. Product Code
Batch No./Lot No. Batch Qtty. (Kg)
Mfg. Date Exp. Date
No. of Containers No. of Packs
Machine Name Processor Name
All the Date produced on Intimation slip is as per BMR & Controlled Record.
Statement:
I have checked the Data keenly and there is no deviation.
INITIATOR
(Prod. Officer) (Sign & Date) Time
B. TO BE FILLED BY QUALITY ASSURANCE DEPARTMENT
Title:
Batch No. Batch Qtty. (Kg)
Mfg. Date Exp. Date
Sampled Qtty. Sampled Packs
Physical Inspection
S.# Observations Yes No.
1. Data produced on intimation is same as BMR/ Controlled Record.
2. Item Information on Container & on intimation is same as BMR.
Quantity Mentioned complies with processing Batch and is
3.
verified.
4. Product is properly closed in containers
5. Area is properly cleaned
6. Quantity Sampled was as per sampling procedure #
Remarks:
Sampled By:
(QA. Officer)
Sign & Date Time
Analysis No:
Received By: Remarks:

(QC. Officer)
Sign & Date Time
11.0 Certificate of Analysis (Solution for Injection):

Document No. QC/SOP/005-A Version No. 000.
Title: Certificate of Analysis (Report) Page 16 of 28
TITLE:
REGISTRATION NO. BATCH NO. /LOT NO.
SECTION ANALYSIS NO.
DOSAGE FORM STAGE
FORMULA NO. PRODUCT CODE
NO. OF CONTAINERS BATCH QTTY. (KG)
Title:
Page 17 of 28
MFG. DATE EXP. DATE
ENV. CONDITIONS RETEST DATE
DATE RECEIVED REFERENCE SOP
SUPPLIER
OBSERVATIONS & SPECIFICATIONS
S.NO TESTS OBSERVATIONS SPECIFICATIONS REFERENCE
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
CONCLUSION
COMPLIANCE WITH YES NO RESULTS

ACCEPTANCE
FINALIZING DATE
CRITERIA
ANALYSED BY: _________________ QC MANAGER: _________________

SIGN & DATE SIGN & DATE
Note-I: The above results are valid for current sample of received at above mentioned Date & time.
Title:
Page 18 of 28
12.0 In-Process Control Form During Ampoules Filling:
12.1 In-Process Control for Volume Filling:
Title of Product
Batch Number
Powder Filling Date Mfg. Date Exp. Date
Fill Volume Recommended Excess Volume

Labeled Size For Mobile Liquids For Viscous Liquids
0.5 mL 0.10 mL 0.12 mL
1.0 mL 0.10 mL 0.15 mL
2.0 mL 0.15 mL 0.25 mL
Lower Volume Limit
5.0 mL 0.30 mL 0.50 mL
10.0 mL 0.50 mL 0.70 mL
20.0 mL 0.60 mL 0.90 mL
30.0 mL 0.80 mL 1.20 mL
50.0 mL or more 2% 3%
12.2 Observed Volumes:
Temp. Hum. Checked Verified
Date Time 1 2 3 4 5
NMT 26 ºC 30-45 % By By
12.3 Total Rejection:

Glass Ampoules Solution Filled
13.0 Request for Analysis for Filled Ampoules:

Title:
Page 19 of 28
Document No. QC/SOP/004-C Version No. 000.
Title: Request of Analysis (Purified Water/Water
Page 19 of 28
for Injection, in-Process/ Finished Products)
C. TO BE FILLED BY PRODUCTION DEPARTMENT
Title:
Department Section
Dosage Type Stage
Formula No. Product Code
Batch No./Lot No. Batch Qtty. (Kg)
Mfg. Date Exp. Date
No. of Containers No. of Packs
Machine Name Processor Name
All the Date produced on Intimation slip is as per BMR & Controlled Record.
Statement:
I have checked the Data keenly and there is no deviation.
INITIATOR
(Prod. Officer) (Sign & Date) Time
D. TO BE FILLED BY QUALITY ASSURANCE DEPARTMENT
Title:
Batch No. Batch Qtty. (Kg)
Mfg. Date Exp. Date
Sampled Qtty. Sampled Packs
Physical Inspection
S.# Observations Yes No.
1. Data produced on intimation is same as BMR/ Controlled Record.
2. Item Information on Container & on intimation is same as BMR.
Quantity Mentioned complies with processing Batch and is
3.
verified.
4. Product is properly closed in containers
5. Area is properly cleaned
6. Quantity Sampled was as per sampling procedure #
Remarks:
Sampled By:
(QA. Officer)
Sign & Date Time
Analysis No:
Received By: Remarks:

(QC. Officer)
Sign & Date Time
14.0 Certificate of Analysis (Filled Vials):

Document No. QC/SOP/005-A Version No. 000.
Title:
Page 20 of 28
Title: Certificate of Analysis (Report) Page 20 of 28
TITLE:
REGISTRATION NO. BATCH NO. /LOT NO.
SECTION ANALYSIS NO.
DOSAGE FORM STAGE
FORMULA NO. PRODUCT CODE
NO. OF CONTAINERS BATCH QTTY. (KG)
MFG. DATE EXP. DATE
ENV. CONDITIONS RETEST DATE
DATE RECEIVED REFERENCE SOP
SUPPLIER
OBSERVATIONS & SPECIFICATIONS
S.NO TESTS OBSERVATIONS SPECIFICATIONS REFERENCE
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
CONCLUSION
COMPLIANCE WITH YES NO RESULTS

ACCEPTANCE
FINALIZING DATE
CRITERIA
ANALYSED BY: _________________ QC MANAGER: _________________

SIGN & DATE SIGN & DATE
Title:
Page 21 of 28
15. Ampoules Optical Checking:
Steps Procedure
Select 100 number of Ampoules which contain 10 Ampoules with particulate matter, 5 bottles with
15.1 molding defect, 10 bottles with less or more volume, 5 bottles with glass particles and 70 clear and
good bottles.
Identify all bottles properly. Now inspect bottles against black and white background, make the list
15.2
of all number of bottles and mention in the table
15.3 Ensure that the intensity of the illumination at the inspection point should have at least 2000 lux.
Temperature should be ambient and should not exceed 25 °C in the summer if not otherwise
15.4
justified.
The relative humidity and air velocity should be controlled and ensure comfortable working
15.5
conditions. The noise level should therefore be below 55dB.
Each object should be inspected for at least 5 seconds against a white background and an
15.6
additional 5 seconds against a black background.
The maximum time for continuous inspection activity between break periods and the total
15.6
maximum inspection time for a shift/workday must be limited.
A good practice is 20 minutes of inspection, followed by a break of at least 5 minutes for a total
15.6
maximum duration of no longer than 4 hours.
15.6 Uninterrupted inspection activity should not exceed 40 minutes.
Optical Check detail:
Poor sealing Sealing defect Particles Molding defect Less Volume Glass Particles
Final Report:
Supervised
Optical Checking Date Operator
By
Total number of Ampoules produced after filling_________________
Number of Ampoules rejected during optical checking ___________
Total No. of Ampoules produced after the optical checking:________
Optical Checking Optical Checking Total Time
Defect Classes Specifications Observations

Which may cause serious adverse patient reaction or death if the product
is used. For example any non-conformity that compromises the integrity
Critical Defect
of the container and thereby risks microbiological contamination of the
sterile product.
Defects that carry risks of temporary impairment or medically reversible
reaction, or involve remote probability of a serious adverse reaction. For
Major defect
Example any defect which causes impairment to the use of the product
(which may result in a malfunctions that makes the product unusable)
Defects which do not impact product performance or compliance; they
are often cosmetic in nature, affecting only product appearance and
Minor Defect
pharmaceutical elegance. Minor defects are not considered to be
rejected product.
16. Batch Packaging Record:
16.1 Packaging Order for Primary & Secondary Packaging: (Original):
Title:
Page 22 of 28
Batch Quantity Mfg./Expiry Date
Required Weighed By Checked By
Title Analysis No. Extra
Quantity (W. House) (Q.A)
I have confirmed that the above dispensed packaging materials are as per approved
packaging order. Moreover, the above dispensed quantity is accurate and they are within
Confirmed expiry.
By.
_____________________ _____________________________
16.2 Packaging Order for Primary & Secondary Packaging: (Warehouse Copy):
Batch Quantity Mfg./Expiry Date
Required Weighed By Checked By
Title Analysis No. Extra
Quantity (W. House) (Q.A)
Title:
Page 23 of 28
I have confirmed that the above dispensed packaging materials are as per approved
packaging order. Moreover, the above dispensed quantity is accurate and they are within
expiry.
Confirmed
By.
_____________________ _____________________________
Title:
Page 24 of 28
16.3 Over Printing Record:
Title of Product
Batch Number
Initiation Date Mfg. Date Exp. Date
Please Pick One type
 Intravenous
 Intramuscular
Tablet Type
 Subcutaneous Type (By Action) Selected Type
 Intradermal 5. General
 Depot 6. Antibiotic
7. Lyophilized
8. Other
Ampoule (ml) Ampoule Color
Flip Off Color Trays/Fixer
Leaflet Unit Carton
Quantity Batch Size No. of Ampoules (App.)
Storage Conditions
16.4 Responsible Person:

I have confirmed that the above dispensed packaging materials and over printing data is accurate.
Pkg.
Supervisor (Sign & Date):_______________ Production Officer (Sign & Date):_________________
QA Officer (Sign & Date):____________________ Production Manager (Sign & Date):________________
16.5 Online Inspection:

Date Time Over General Appearance Ampoule Leaflet Pack Observed By
Title:
Page 25 of 28
Prod. QA.
Printing Carton Label Fixing Size
Officer Officer
16.6 Reconciliation of Packaging Components:

Quantity Rejected Allowable Qty.
S.# Items Units
Received Used Unit % age Wastage Returned
1. Ampoules No. 2%
2. Trays No. 1%
Title:
Page 26 of 28
3. WFI Amp. ( ml) No. 1%
4. Labels No. 3%
5. Unit Cartons No. 2%
6. Leaflets No. 1%
7. Shippers No. 1%
17. Material for Destruction/Return:
S.# Items Units Quantity Percentage

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
I have confirmed that the above data is accurate and is verified.
Confirmed
By.
___________________________ _____________________________
Production Officer (Sign & Date) Production Manager (Sign & Date)
18. Yield Statement:

Manufacturing
Powder Dispense Reworking Left Variance (C) Remarks
(A) (B) (A-B) (Kg)
Objective Fill Volume of Ampoules (D):____________________________________________________

Optical Checking:
Title:
Page 27 of 28
Ampoules Reject During the Optical In-process QC Samples QC Sample for Sterility &
Checking (E) (F) Chemical Analysis (G)
Packing (Sales)
Total Qty. Packed In-process QC Sample Total Unit
(H) (I) (H+I)
Partial transfer, if any (Sales): ______________________________________________________
Net unit transferred to the FGWH sales (H-I): __________________________________________
Net unit transferred to the FGWH sales (J-K): __________________________________________
Sales:
Theoretical M = C x 1000 x 1000
Yield Objective Fill Weight (D)
Actual yield N = (H+I) x 100
L
Given an explanation if the reconciliation is outside the stated limit.
I have confirmed that the above data is accurate.
Production Officer (Sign & Date):_______________ Production Manager (Sign & Date):_____________
QA Officer (Sign & Date):______________________ QA Manager (Sign & Date):____________________

Title:
Page 28 of 28
19. Microbiological reports:
(Please see the attachment.
20. Finished Product Transfer Slip:
Product Name: _______________________ Batch #.__________________ Batch Size:______________
Mfg. Date : _______________________ Expiry Date:____________ Date:_________________
Qty. Transferred
Pack Total Qtty. Received
Date Time Master Status Issued By
Size Loose Pack Transferred By
Carton
Total Quantity transferred on Completion of Batch:____________________
Pack Size:______________________
Sample to Q.C _________________
Total Batch Qty:__________________
Comments (if any):
I have confirmed that the above data is accurate.
Production Officer (Sign & Date):_______________ Production Manager (Sign & Date):_____________
QA Officer (Sign & Date):______________________ Warehouse In-Charge (Sign & Date):____________

2-E.BMR Liquid Injection

Uploaded by

Copyright:

Available Formats

2-E.BMR Liquid Injection

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

2-E.BMR Liquid Injection

Uploaded by

Copyright:

Available Formats

What is the purpose of the document?

What is the purpose of the document?

What information is included in the document?

What information is included in the document?

Document No. WB/PD/SOP/002-E Version No. 000.

Issue Date 25/03/2019 Effective Date 01/04/2019

Flip Off Color Trays/Fixer

Leaflet Unit Carton

Quantity Batch Size No. of Ampoules (App.)

2. Product Batch Manufacturing Record Issuance:

6. Instructions for Production Department:

6.4 Manufacturing/Process Requirements:

Specifications Regarding Air Sampling:

Total Number of Ampoules rejected

8.2 Sterile Solution Preparation:

Stirring Time:____________ Stirring Speed:________________

8.3 Sterilization of Ampoules:

(Operation of dry heat Sterilizer)

Machine parts if any sterilize

Total no of Ampoules Sterilized

8.4 Autoclavation of Utilities:

8.5 Sterilization of Active through Ultra Violet Lights:

Total number of container:____________________

Check the differential pressure of the area is negative as compared

Ensure the batch, documents, labels, material, powder, tablets or

9.2 Initial Test before Injection/Ampoule Filling:

9.3 List of Personnel in Area:

10.0 Request for Analysis for Solution for Injection:

Received By: Remarks:

11.0 Certificate of Analysis (Solution for Injection):

COMPLIANCE WITH YES NO RESULTS

ANALYSED BY: _________________ QC MANAGER: _________________

Fill Volume Recommended Excess Volume

12.3 Total Rejection:

13.0 Request for Analysis for Filled Ampoules:

Received By: Remarks:

14.0 Certificate of Analysis (Filled Vials):

Title: Certificate of Analysis (Report) Page 20 of 28

COMPLIANCE WITH YES NO RESULTS

ANALYSED BY: _________________ QC MANAGER: _________________

Defect Classes Specifications Observations

Flip Off Color Trays/Fixer

Leaflet Unit Carton

Quantity Batch Size No. of Ampoules (App.)

16.4 Responsible Person:

QA Officer (Sign & Date):____________________ Production Manager (Sign & Date):________________

16.5 Online Inspection:

16.6 Reconciliation of Packaging Components:

17. Material for Destruction/Return:

S.# Items Units Quantity Percentage

18. Yield Statement:

Objective Fill Volume of Ampoules (D):____________________________________________________

Partial transfer, if any (Sales): ______________________________________________________

Net unit transferred to the FGWH sales (H-I): __________________________________________

Net unit transferred to the FGWH sales (J-K): __________________________________________

Given an explanation if the reconciliation is outside the stated limit.

I have confirmed that the above data is accurate.

QA Officer (Sign & Date):______________________ QA Manager (Sign & Date):____________________

20. Finished Product Transfer Slip:

Product Name: _______________________ Batch #.__________________ Batch Size:______________

Stirring Time: Stirring Speed:____

ANALYSED BY: _ QC MANAGER: _

ANALYSED BY: _ QC MANAGER: _

QA Officer (Sign & Date):____ Production Manager (Sign & Date):

QA Officer (Sign & Date):__ QA Manager (Sign & Date):

Product Name: _______ Batch #. Batch Size:

Mfg. Date : _______ Expiry Date: Date:_

QA Officer (Sign & Date):__________ Warehouse In-Charge (Sign & Date):