Methylbrill 500mcg Tablet T-043

BRIELL Pharmaceuticals
BATCH MANUFACTURING RECORD
Product Name: METHYLBRIL 500mcg Tablet

1 Batch Number: T-043
3 Batch Size: 4000 Tabs . .
Tablet Section
4 Manufacturing Date: 06-2022 .
5 Expiry Date: 05-2024 .
6 Shelf Life: 24Months .
7 Pack Size: 2*10s
8 Registration Number: NA .
9 BMR Issued Date:.
10 BMR Submission Date:
Instruction:
1. Fill the BMR accurately, avoid cutting & overwriting. In case of any mistake/ error, cut that word or line with a single stroke and do initials there.
2. Check the materials for their identity (by name, Batch no and Release status) and quantity.
3. Ensure line clearance prior to start of each process.
4. Ensure compliance of environmental conditions (Temperature, Relative Humidity and Differential Pressure) during all manufacturing operations whenever necessary.
5. Use mask, Gloves, cap and uniform during process. (As per requirement)
6. Do not touch any moving parts of the machine while in operation. Use all the electrical board/panel carefully and keep away from any spillage.
7. Strictly follow all the steps of standard operating procedures.
8. Make sure all safety guards and side panels are in position before and after starting machine.
9. In case of any deviation, immediately inform and get permission from senior corrective and preventive action and document all the deviations.
10. Product Status of all the steps of manufacturing and packing operations must be displayed.
Note: All the equipment and utensils must be properly cleaned and properly labeled.
Reviewed By: ____________________ Approved By:________________

Section Incharge QA Officer
Page 1 of 47
BRIELL PHARMACEUTICALS Production Dept.
PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

Product Code: --
Revision no: 00
Reg NO:----- BATCH NO: T-043 Batch Size:4000 Tab Mfg.: 06-2022 Exp.: 05-2024 Revision date:01-02-2022
Prepared By Verfied By Approved By Authorized By
Production Incharge Quality Control Incharge Quality Assurance Incharge Director Operations
BMR COMPLIANCE CHECKLIST

Availability of Availability of
Documents and Page Sr. Documents and Page
Sr. # TABLE OF CONTENTS Compliance TABLE OF CONTENTS Compliance
No. # No.
Yes  √ No  x Yes  √ No x
1. Cover page & General Instructions 01 24 Weight Record of Coated Tablets & Yield Calculation 27
2. BMR Compliance Checklist 02 25 Quality Control Testing Report After Coating 28
3. Master Formulation 03 26 Packing Order 29-30
4. Calculation of API 04 27 Line Clearance Checklist for Blistering 31
5. Manufacturing Order 05-06 28 Embossing Information 32
6. Line Clearance Checklist for Dispensing 07 29 In process Control sheet for Blistering 33
7. Verification of Dispensed Raw Materials 08 30 Team Layout Sheet at Blistering Stage 34
List of Equipment Used During Manufacturing & Packing 09 31 Line Clearance Checklist for Printing Machine & Area 35
8.
Process
9. Line Clearance Checklist for Granulation 10 32 Over Printing Information 36-37
10. Standard Manufacturing Procedure for Granulation 11-13 33 In process Control SHEET for Printing 38
11. Quality Control Testing Report (Moisture contents) 14 34 Team Layout Sheet at Printing Stage 39
12. Granulation Procedure (Final Mixing) 15 35 Line Clearance Checklist for Packing 40
13. Weight Record of Grains & Yield Calculation 16 36 Team Layout Sheet at Packing Stage 41
14. Quality Control Testing Report at Final Mixing Stage 17 37 In process Control SHEET for Packing 42
15. Line Clearance Checklist for Compression 18 38 Certificate of Analysis 43
16. Compression Start Up Analysis Sheet 19 39 Finished Goods Transfer Note 44
17. Weight Control Sheet for Compression 20 40 Packing Material Reconciliation 45
18. In process Weight Monitoring Sheet 21 41 Batch Reconciliation 46
19. In process Control Sheet for Compression 22 42 Destruction Note 47
20. Weight Record of Compressed Tablet & Yield Calculation 23 43
21. Quality Control Testing Report After Compression 24 44
22. Line Clearance Checklist for Coating 25 45
23. Standard Manufacturing Procedure for Coating 26 46
All the above documents are checked and found satisfactory. Checked By: _______________ Reviewed By: ____________
Section In charge QA Officer
Page 2 of 47

Product Code: --
Revision no: 00
MASTER FORMULATION FOR RAW MATERIAL
Each Tablet Standard Batch

Sr. # Raw Materials
Contains (mg)1tab Size(kg) 4000tab
1. Mecobalamin 0.5 0.002
2. Lactose Monohydrate 43 0.172
3. Starch 52 0.208
4. Avicel 102 88 0.352
5. PVP K-30 4.3 0.017
6. Mag. stearate 1.5 0.006
7. Primojel 5.5 0.022
8. Talcum 5.2 0.021
9. IPA 0.006 0.024
10. Ethroycin Red Color 2.63 0.0105
11. Coating Material 26.30 0.1052
12. IPA 0.30 0.0012
13. Titanium Dioxide 3.86 0.0154
14. PEG 6000 87.60 0.3504
Page 3 of 47

Product Code: --
Revision no: 00
CALCULATION OF ACTIVE PHARMACEUTICAL INGREDIENT (API)
API Mecobalamin................500mcg
Each film coated tablet contains:
Label Claim Mecobalamin......... 500mcg
(USP Specifications)
Assay of API (Potency): (as such)
Overage of API: _______________________
Label Claim: 500mcg per Tablet
Weight of API per tablet( mcg) = 100_ x Label Claim = mcg/Tablet

Assay of API (potency)
Weight of API per batch(kg) = mcg/Tablet x batch size = kg/batch size

1000g x1000g
Total Weight of API (g): __________kg________________________
Remarks (if any): __________________________________________
Calculated By:_______________Checked By: ____________Verified By: ___________ Approved By: ____________ Section Incharge
Production Manager QC Manager QA Manager
Page 4 of 47

Product Code: --
Revision no: 00
MANUFACTURING ORDER For Production Use

Date: _____________
Product Name: METHYLBRILl 500mcg Tablet Batch No: T-043
Manufacturing Date: 06-2022 Expiry Date: 05-2024
Batch Size (Kg): 0.800kg Batch Quantity: 4000 tab
Registration No: ----- Shelf Life : 24months
Section: General Tablet Section
Checked Received By
Qty. Additional Qty Dispensed Verified
QC. No Raw Materials Qty. Issued(kg) Return Actual Used By Disp.
By QA Officer
Production
Reqd.(kg) Issued By Pharmacist Pharmacist
Mecobalamin 0.002
Lactose Monohydrate 0.172 0.172
Starch 0.208 0.208
Avicel 102 0.352 0.352
PVP K-30 0.017 0.017
Mag. stearate 0.006 0.006
Primojel 0.022 0.022
Talcum 0.021 0.021
IPA 0.024 0.024
0.0105 0.0105
0.1052 0.1052
IPA 0.0012 0.0012
Titanium Dioxide 0.0154 0.0154
PEG 6000 0.3504 0.3504
Calculated By:_________________ Checked By: ____________________ Verified By: ________________ Approved by: _________
Section Incharge Production Manager QC Manager QA manager
Page 5 of 47

Product Code: --
Revision no: 00
MANUFACTURING ORDER For Warehouse Use

Date: _____________
Manufacturing Date: 06-2022 Expiry Date: 05-2024
Batch Size (Kg): kg Batch Quantity: 4000 tab
Registration No: Shelf Life : 24months
Section: General Tablet Section
Checked Received By
Qty. Additional Qty Dispensed Verified
QC. No Raw Materials Qty. Issued Return Actual Used By Disp.
By QA Officer
Production
Reqd. Issued By Pharmacist Pharmacist
Mecobalamin 0.002
Lactose Monohydrate 0.172 0.172
Starch 0.208 0.208
Avicel 102 0.352 0.352
PVP K-30 0.017 0.017
Mag. stearate 0.006 0.006
Primojel 0.022 0.022
Talcum 0.021 0.021
IPA 0.024 0.024
0.0105 0.0105
0.1052 0.1052
IPA 0.0012 0.0012
Titanium Dioxide 0.0154 0.0154
PEG 6000 0.3504 0.3504
Calculated By:_________________ Checked By: ____________________ Verified By: ________________ Approved by: _________
Section Incharge Production Manager QC Manager QA manager
Page 6 of 47

Product Code: --
Revision no: 00
LINE CLEARANCE CHECKLIST FOR DISPENSING

DISP. OFFICER QA OFFICER
Sr. # CLEARANCE PARAMETERS Yes No Yes No
01 Is area properly cleaned and labeled?    
02 Are there any traces of previous Product _________________Batch # ____________in    
a- Area, Equipment, Tools, Containers, Pallets    
b- Dispensing Hood    
c- Platform Weighing balance    
d- Top Loading Weighing balance    
STARTUP PARAMETERS
03 Are equipment & containers properly cleaned & labeled with Equipment / Product Identification Label?    
04 Are Personnel in the dispensing room wearing specified cleaned uniform, gloves and mask?    
Is Temperature and relative humidity in accordance with the requirements and recorded?
05    
Temperature:_______(°C) & Humidity:_________(%)
06 Are log books maintained properly?    
07 Are weighing balances in calibrated status?    
08 Is Differential Pressure in accordance with the requirements and recorded?    
09 Is dispensing hood properly in working condition?    
10 Are all dispensing tools used in dispensing, properly cleaned and wrapped in polythene bag having cleaned status?    
11 Are Raw materials to be dispensed having proper identification label and QC release?    
12 Is approved manufacturing order pertaining to the batch to be dispensed, available and as per requiBlack batch size?    
13 Are Dispensing tags available as per manufacturing order?    
All the above parameters are checked and found satisfactory
PRODUCTION PHARMACIST _______________ DATE & TIME:_______________ LINE CLEARANCE AWARDED: YES □ NO □
QA OFFICER ___________________ DATE & TIME:________________ REMARKS: _______________________
LINE CLEARANCE FOR MORE THAN ONE TIME AFTER RECHECKING OF ABOVE PARAMETERS EACH TIME
DATE TIME LINE CLEARANCE STATUS CHECKED BY RECHECKED BY IPQC
Page 7 of 47

Product Code: --
Revision no: 00
VERIFICATION OF DISPENSED RAW MATERIALS

All the Dispensed Raw Material Identification Slips Are Attached Here
All the above dispensed materials are checked and received as per Manufacturing order.
Checked by: ___________________ Verified by: ___________________
Production Pharmacist QA Officer
Page 8 of 47

Product Code: --
Revision no: 00
LIST OF EQUIPMENT USED DURING MANUFACTURING

AND PACKING PROCESS and CLEANING STATUS
Sr. Equipment ID
Description Cleaning Status
#
Sigma Mixer BM/R&D/001
1
Rotary wet granulator BM/R&D/002
2
Powder tray dryer BM/R&D/003
3
Oscillating Dry granulator BM/R&D/004
4
5 Double cone mixer BM/R&D/005
6 Rotary tablet press ZP-17 BM/R&D/006
7 Dust collector -----
8 Double jacket coating mixer BM/R&D/007
9 Coating pan SS BM/R&D/008
10 ALU-PVC blister machine 4001
11 LASER Jet printer 4003
12 Conveyer belt 4002
All the above mentioned equipment are checked and found in proper working condition.
Checked By: ___________________ Verified By: ______________
Production Pharmacist QA Officer
Page 9 of 47

Product Code: --
Revision no: 00
LINE CLEARANCE CHECKLIST FOR GRANULATION

PRD OFFICER QA OFFICER
Sr.# CLEARANCE PARAMETERS
Yes No Yes No
02 Are there any traces of previous Product ______________Batch #___________in    
a- Area, Containers, Equipment & Measuring Tools    
b- Mechanical Sifter    
c- Mixer Granulator    
d- Platform Weighing Balance    
START UP OPERATION
03 Are equipments & containers properly labeled with Equipment / Product Identification Label?    
04 Are personnel in the granulation area wearing specified clean uniform, gloves and masks?    
06 Is weighing balance calibrated?    
Is Temperature and relative humidity in accordance with the requirements and recorded?
07    
08 Is Differential Pressure in accordance with the requirements and recorded?    
09 Are dispensed raw materials pertaining to respective batch available?    
10 Is documentation of previous stages completed?    
All the above parameters are checked and found satisfactory.
PRODUCTION PHARMACIST _______________ DATE & TIME:_______________ Line Clearance awarded: YES □ NO □
QA OFFICER ___________________ DATE & TIME:________________ REMARKS: _______________________
LINE clearance for more than one time after rechecking of above parameters each time
Date Time Line clearance status Checked by Rechecked by IPQC
STANDARD MANUFACTURING PROCEDURE FOR GRANULATION

Page 10 of 47

Product Code: --
Revision no: 00
Performed Checked By Verified

Step
GRANULATION PROCEDURE By Production By QA
#
Operator Pharmacist Officer
1 DRY MIXING:
Sr.# Ingredients Actual Wt. (Kg)
1. Lactose Monohydrate
2. Starch
Sieve materials through mesh # 12. Transfer the above sieved material to mixer.
Mix the above material for 15 to 20 minutes.
Mixing Started at: ____________ Mixing Completed at: __________
Total Mixing Time: ___________ Date:__________
Page 11 of 47

Product Code: --
Revision no: 00

Step GRANULATION PROCEDURE By Production By QA
# Operator Pharmacist Officer
2 WET MIXING:
2. PVP K-30
3. IPA
Now add binder solution into mixer & wet the previously sieved material present in mixer. Run the mixer for 10 minutes.
3
Wet mixing started at:________ Wet mixing completed at:________
Total wet mixing Time: ________ Date:__________
WET GRANULATION:
4 Pass the wet material through rotary granulator to obtain grains which are then spread into trays for drying.
Wet granulation started at:________ Wet granulation completed at:________
Total wet granulation Time: ________ Date:__________
DRYING:
After wet granulation transfer the granulated material to Tray Dryer and dry the material at 70°C.
Drying Started at: _________ Drying Completed at: _________
Total Drying Time: ________ Date:__________
Send request to QA for sampling after complete drying of grains for the checking of Moisture contents which should be
NMT 5 %.
Page 12 of 47

Product Code: --
Revision no: 00

Step GRANULATION PROCEDURE By Production By QA
5 SIEVING :
After drying, fix _____ # mesh on oscillating granulator and pass the dried material through it. Collect the grains in
polythene lined labeled containers.
Sieving Started at: _________ Sieving Completed at: _________
Total Sieving Time: ________ Date:__________
Page 13 of 47

Product Code: --
Revision no: 00
QUALITY CONTROL TESTING

Performed By: ______________ Checked by: _________________ Approved by: ______________ REPORT (MOISTURE CONTENT)
QC Analyst Asst. QC Manager QC Manager
Filled By Production
Date: Time: Section: Stage: Section Incharge (Sign)
General Tablet Section After Drying
Filled By Quality Assurance
Date: Time: Sampled By: Quantity: QA Officer (Sign)
Analysis Report (Filled By QC)

Sample Receiving Sample Receiving Sample Release Sample Release Time: QC Reference
Date: Time: Date: No.
Tests Specifications Results

Loss on Drying NMT 5.0 %
Remarks: _________________________________________________________________________
Page 14 of 47

Product Code: --
Revision no: 00

Step # FINAL MIXING PROCEDURE By Production By QA
Operator Pharmacist Officer
5 FINAL MIXING:
1. Mecobalamin
2. Magnesium Stearate
3. Primogel
4. Avicel-102
6 5. Talcum
Sieve the above ingredients through 30# screen and finally mix with dried granulates in Double Cone Mixer for 25-30
minutes.
Mixing Started at: _________ Mixing Completed at: _________
Total Mixing Time: ________ Date:__________

Discharge the material from cone mixer through butterfly valve in the tarred containers equipped with clean
polythene bags. Send request to QA for sampling after final mixing.
Sampled Quantity: ______________ gm
Page 15 of 47

Product Code: --
Revision no: 00
WEIGHT RECORD OF GRAINS & YIELD CALCULATION

Date: ______________
Container Performed By Checked By Production Verified By QA
Gross Weight (Kg) Tare Weight (Kg) Net Weight (Kg)
Number Operator Pharmacist Officer
1
2
3
TOTAL NET WEIGHT _________________Kg.
Theoretical weight of Grains =___________ Kg

Actual weight of Grains =_______________ Kg
% Yield = __________________________ %
Wastage = ____________________________%
Note: Store the grains with proper Air tight Polythene bags in labeled containers in in-process Quarantine Area.
Performed by: ___________Checked by: ________________ Verified by: ____________

Operator Production Pharmacist QA Officer
Transfer Of Grains from In-process Quarantine Area to Compression Section:
Total Weight received: _______________ Date: _________________________
Recieved by: ______________________ Checked by: ___________________

Operator Production Pharmacist
Page 16 of 47

Product Code: --
Revision no: 00
QUALITY CONTROL TESTING REPORT AT FINAL MIXING STAGE

General Tablet Section Final mixing

Sample Receiving Date: Sample Receiving Time: Sample Release Date: Sample Release Time: QC Reference No.

Physical Appearance Light Pink Granular Powder
Identification:
Loss on Drying NMT 5%
Assay: 92-108% as label claim of Mecobalamin
Proposed weight: Compression Range:
Remarks: _________________________________________________________________________
QC Analyst Asst. QC Manager QC Manager
Performed By: ______________ Checked by: _________________ Approved by: ______________
Page 17 of 47

Product Code: --
Revision no: 00
LINE CLEARANCE CHECKLIST FOR COMPRESSION

Sr.# PRD OFFICER QA OFFICER
CLEARANCE PARAMETERS Yes No Yes No
02 Are there any traces of previous Product _____________ Batch #_________ in    
a- Area, Containers, Machine Tools.    
b- Tablet Compression Machine    
c- Top Loading Weighing Balance    
START UP OPERATION
04 Are personnel in compression area wearing specified cleaned uniform, gloves and mask?    
05 QC release of the batch to be processed is present?    
07 Is balance in calibrated status?    
Is Temperature And relative humidity in accordance to the requirements and recorded?
08
   
09 Is Differential Pressure in accordance to the requirements and recorded?    
PRODUCTION PHARMACIST:_______________ DATE & TIME:_______________ Line Clearance awarded: YES □ NO □
QA OFFICER:_____________________ DATE & TIME:________________ REMARKS: ___________________________________
Page 18 of 47

Product Code: --
Revision no: 00
PRODUCT SPECIFICATIONS (CORE TABLETS)

Physical Appearance: Light Pink Colored One Side Engraved Cut line Round Tablet
Punch Shape: Round
Punch size: 5 mm
Average weight: mg / tablet
Weight variation Limit: 200± 7.5 %
Range: 185-215mg
Width: 8±0.04mm
Thickness: 5±0.04mm
Hardness: NMT 10 kg
Disintegration time: NMT 15 mint
Friability: NMT 1 %
Punches, Dies and Tablets verification:
Dies & Punches should be checked for proper fitting. Tablets of first round checked by Production Pharmacist (all physical parameters except disintegration) and after
machine adjustment Production pharmacist will send intimation to concerned QA Officer to collect sample for physical analysis such as Appearance, Diameter, Thickness,
Hardness, Friability, Average Wt., Disintegration Time, and Wt. Variation of tablets.
Page 19 of 47

Product Code: --
Revision no: 00
COMPRESSION START UP ANALYSIS SHEET

General Tablet Section Compression
Date: Time: Sampled By Quantity QA Officer (Sign)
Average Weight: Range:

Sr. # Wt. / Tablet (mg) Sr. # Wt. / Tablet (mg) Sr. # Wt. / Tablet (mg) Sr. # Wt. / Tablet (mg)
1 6 11 16
2 7 12 17
3 8 13 18
4 9 14 19
5 10 15 20
Avg. Wt. / 20 Tablets :
Hardness:
Disintegration Time :
Friability :
Width:
Thickness:
Remarks ( if any ) :
QC Analyst _______________________ QC Manger __________________
Page 20 of 47

Product Code: --
Revision no: 00
IN-PROCESS WEIGHT MONITORING SHEET

Date: ___________ Start Time: ____________ Close Time: ___________
Proposed weight: Lower Limit : Upper Limit:
Date
Sr.#
Time
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Avg. Wt.
Production Officer ________________ QA Officer : ________________

Note: 1) QA officer will use Black ball point. 2) In process entries are taken every 45 minutes by QA and production alternatively.
Page 21 of 47

Product Code: --
Revision no: 00
INPROCESS CONTROLSHEET FOR COMPRESSION
S. No Time Disintegration Friability Hardness Length/ Thickness Color of Checked By

Time Diameter Tablet
Checked by: __________________ Verified by: ____________

Production Officer QA Officer
Page 22 of 47

Product Code: --
Revision no: 00
WEIGHT RECORD OF COMPRESSED TABLET & YIELD CALCULATION

Date: ______________
Container Tare Weight Net Weight Checked By Production Verified By QA
Gross Weight (Kg) Performed By Operator
Number (Kg) (Kg) Pharmacist Officer
1
4
Theoretical weight of grains:_____________ Kg Actual weight of compressed tablets:___________ Kg
% Yield = _________________ % % Wastage = ________________%

Note: Store the core tablets in proper Air tight Polythene bags, in labeled containers, in in-process Quarantine Area
Performed by: ____________ Checked by: __________________ Verified by: ____________

Transfer Of Compressed Tablets to Coating Section:
Total Weight received: _______________ Date: __________________________
Performed by: _____________________ Checked by: ____________________

Page 23 of 47

Product Code: --
Revision no: 00
QUALITY CONTROL TESTING REPORT AFTER COMPRESSION

General Tablet Section Compression


Sample Receiving Date: Sample Receiving Time: Sample Release Date: Sample Release Time: QC Reference No.

Physical Appearance Round Shape Core Tablet with engraved cut line on one side
Identification:
Average weight/Tablet 185-215mg/tab
Width 8±0.04mm
Thickness 5±0.04mm
Hardness NMT 10 kg
Friability NMT 1 %
Disintegration Time NMT 15mint
Assay: 92-108% of the label claim of Mecobalamin
QC Analyst Asst. Manager QC QC Manager
Performed By: ______________ Checked by: ________________ Approved by: ______________
Page 24 of 47

Product Code: --
Revision no: 00
LINE CLEARANCE CHECKLIST FOR COATING

02 Are there any traces of previous Product _______________ Batch #_________ in    
a- Area, Containers, Stools, S.S bowl    
b- Conventional Coating Pan    
START UP OPERATION
04 Are personnel in the blistering room wearing specified clean uniform, gloves and mask?    
06 Is coating machine specific parts (gauges) in calibration status?    
Are Temperature and relative humidity in accordance to the requirements and recorded?
07 Temperature:_______(°C) & Humidity:_________(%)
   
PRODUCTION PHARMACIST: _____________ DATE & TIME:_______________ Line Clearance awarded: YES □ NO □
QA OFFICER: _________________ DATE & TIME:________________ REMARKS: _________________________________
Page 25 of 47

Product Code: --
Revision no: 00
STANDARD COATING PROCEDURE (FILM COATING)

Step
COATING PROCEDURE By Production By QA
COATING SOLUTION PREPARATION:
1. Sr Ingredients Actual Wt.
1. Coat Dry
2. Red color
3. Titanium Dioxide
4. PEG 6000
Take above mentioned materials one by one and mix for 45 minutes.
Mixing started at: ____________ Mixing completed at: _________
Total Mixing Time : _________ Date:__________ Filter the coating solution through appropriate filters.
COATING:
Dedust the core tablets before loading into the pan. Load the core tablet in the Coating pan using SS Bowl. Switch ON the
main power supply & warm the cores for 5 minutes.
Spray the coating solution on tablet bed till all the solution is used. Adjust and maintain the following parameters during
coating.
Coating started at: ____________ Coating completed at: _________
Total Coating Time : _________ Date:__________
After complete coating, transfer the coated tablets from coating pan in the tarred containers equipped with clean polythene
bags. Send request to QA for sampling for physical and chemical analysis & calculate %age weight gain & %age yield.
Page 26 of 47

Product Code: --
Revision no: 00
WEIGHT RECORD OF COATED TABLETS & YIELD CALCULATION

Date: ______________
Checked By
Container Tare Weight Net Weight Performed By Verified By QA
Gross Weight (Kg) Production
Number (Kg) (Kg) Operator Officer
Pharmacist
1
2
3
4
Theoratical Weight:_________ kg Actual weight of coated tablet:____________ Kg
% Yield = _________________ % % Wastage = ________________%
Note: Store the coated tablets in proper Air tight Polythene bags, in labeled containers, in in-process Quarantine Area
Performed by: ____________ Checked by: __________________ Verified by: ____________

Transfer Of Coated Tablets to Blistering Section:
Total Weight received: _______________ Date: __________________________
Performed by: _____________________ Checked by: ____________________
Operator Packing Pharmacist
Page 27 of 47

Product Code: --
Revision no: 00
QUALITY CONTROL TESTING REPORT AFTER COATING

Date:
Time: Section: Stage: Section Incharge (Sign)
General Tablet Section Coating
QA Officer
Date: Time: Sampled By: Quantity:
(Sign)

Sample Receiving Sample Receiving Sample Release Sample Release QC Reference
Date: Time: Date: Time: No.

Physical Appearance Red Color Round Shape film Coated Tablet with engraved cut line on one side
Identification:
width 8±0.04mm
Thickness 5±0.04mm
Hardness NMT 10 kg
Friability NMT 1 %
Remarks: _______________________________________________________________________________
Page 28 of 47

Product Code: --
Revision no: 00
PACKING ORDER
Date: ______________
Performed By: ______________ Checked by: ________________ Approved by: ______________
Product Name: QC Analyst METHYLBRILl 500mcg Tablet
Asst. Q.C. Manager Batch No:
Q.C. Manager T-043
Mfg. Date: 06-2022 Expiry Date: 05-2024
Batch Size: 200 packs Batch Quantity: 4000 tablet
Product Reg. No: Shelf Life: 24months
Section: General Tablet Section Memo: Commercial
Actual Checked By Received By

Quantity Qty. Additional Verified
QC. No Packaging Material Return Quantity Wastage Warehouse Packing
Required Issued Qty. By QA Officer
Used Officer Pharmacist
5
PVC FOIL
PRINTED FOIL 0.72
UNIT CARTON 200
LEAFLET 200
PACKING TAPE 1
SHIPPER 1
Prepared By: __________ Reviewed By:______________ Verified By: ____________ Approved By: ___________
Section Incharge Production Manager Store Incharge QC Manager
Page 29 of 47

Product Code: --
Revision no: 00
PACKING ORDER
Date: ______________
Mfg. Date: 06-2022 Expiry Date: 05-2024
Batch Size: 200 Packs Batch Quantity: 4000 tablet
Product Reg. No: Shelf Life: 24Months
Section: General Tablet Section Memo: Commercial
Actual Checked By Received By

Quantity Qty. Additional Verified
QC. No Packaging Material Return Quantity Wastage Warehouse Packing
Required Issued Qty. By QA Officer
Used Officer Pharmacist
5
PVC FOIL
PRINTED FOIL 0.72
UNIT CARTON 200
LEAFLET 200
PACKING TAPE 1
SHIPPER 1
Prepared By: __________ Reviewed By:______________ Verified By: ____________ Approved By: ___________
Section Incharge Production Manager Store Incharge QC Manager
Page 30 of 47

Product Code: --
Revision no: 00
LINE CLEARANCE CHECKLIST FOR BLISTERING

02 Are there any traces of previous Product _______________ Batch #________ in    
a- Area, Conveyer Belt, Trays, Containers, Stools, S.S bowl    
b- Automatic Blister Machine    
START UP OPERATION
04 Are personnel in the blistering room wearing specified clean uniform, gloves and mask?    
06 Is blistering machine specific parts (gauges) in calibration status?    
07
   
08 Is QC released packaging material to be used for respective batch available?    
09 Correct Embossing of Batch no. & Expiry date on Blisters.    
PRODUCTION PHARMACIST: ___________ DATE & TIME:_______________ Line Clearance awarded: YES □ NO □
QA OFFICER : _____________ DATE & TIME:________________ REMARKS: _________________________________
Page 31 of 47

Product Code: --
Revision no: 00
EMBOSSING INFORMATION
Batch No.& Expiry Date
Attach Verified Embossed Empty Blister Specimen Here

Attach First Blister Attach Second Blister Attach Third Blister
Performed By: ____________ Checked By: ___________________ Verified By: ___________

Page 32 of 47

Product Code: --
Revision no: 00
IN-PROCESS CONTROL SHEET FOR BLISTERING OF TABLETS
Status
YES : ✔ NO : X
Date: _____________Start Time: ____________Close Time: ___________
Checking Parameters
Date Time Bulk inspection of Embossing Blisters Foil Status Checked by Remarks
product Batch No. Exp. Date Leakage Test Cutting Text Printing
REMARKS: ________________________________________________________________________________
Production Pharmacist________________ QA Officer: ________________
Note: 1) QA officer will use Black ball point while Production officer will use Blue ball point.
2) In process entries are taken every 30 minutes by QA and production alternatively.
Page 33 of 47

Product Code: --
Revision no: 00
TEAM LAY OUT SHEET AT BLISTERING STAGE

Start Time: Close Time:
Start Date: Close Date:
Name Time In Time Out Total Time
Performed By: ____________ Checked By: ____________________

Page 34 of 47

Product Code: --
Revision no: 00
LINE CLEARANCE CHECKLIST FOR PRINTING

01 Is area properly cleaned andlabeled?    
02 Are there any traces of previous Product _______________ Batch #________ in    
a- Area, Conveyer Belt    
START UP OPERATION
03 Are equipment & containers properly cleaned &labeled withEquipment / Product Identification Label?    
04 Are personnel in the Printing room wearing specified clean uniform and mask?    
05 Is printing machine specific parts (gauges) in calibration status?    
06    
TEMP______HUMIDITY_____
07 Is QC released packaging material to be used for respective batch available?    
09 Correct Printing of Batch no. ,Mfg Date &Expiry date .    
_______________________
PRODUCTION OFFICER DATE &TIME:_______________ Line Clearance awarded: YES □ NO □
___________
QA OFFICER DATE &TIME:________________ REMARKS: ________________________________________________
Page 35 of 47

Product Code: --
Revision no: 00
OVER PRINTING INFORMATION

Date: Time:
Batch No.: Batch Size:
Operator (Name): Signature:
Over printing information on unit carton:

Batch # Mfg. Date Expiry Date MRP Rs.
Printing Incharge: ___________Production Pharmacist: ___________QA Officer: ___________
Page 36 of 47

Product Code: --
Revision no: 00
ATTACH VERIFIED UNIT CARTON HERE
N-PROCESS CHECK SHEET FOR PRINTING

Checked by
Date Time B. No Mfg. Date Expiry Date M.R.P Rs.
Prod. QA
Page 37 of 47

Product Code: --
Revision no: 00
Page 38 of 47

Product Code: --
Revision no: 00
TEAM LAY OUT SHEET AT OVER PRINTING STAGE

Start Time: Close Time:
Start Date: Close Date:
Date
Operator
Performed By: ____________ Checked By: ____________________

Operator Production Officer
LINE CLEARANCE CHECKLIST FOR PACKING

Sr.# CLEARANCE PARAMETERS Yes No Yes No
Page 39 of 47

Product Code: --
Revision no: 00
02 Are there any traces of previous Product ____________Batch__________ in Area, Conveyer Belt, Shippers & Pallets    
START UP OPERATION
03 Are equipment cleaned & shippers properly labeled with Equipment / Product Identification Label?    
04 Are personnel in the Packaging area wearing specified clean uniform?    
06 Is QC released Packaging material pertaining to respective batch available?    
Are Temperature and relative humidity in accordance to the requirements and recorded?    
07
08 Correct Over printing information on unit Carton    
a- Product Name    
b- Pack Size / Strength    
c- Batch No.    
d- Mfg. Date , Expiry Date    
e- MRP / PS Stamp    
09 Correct Embossing/ Over printing information on Blisters available?    
10 Presence of literature?    
PRODUCTION OFFICER:______________ DATE & TIME:_______________ Line Clearance awarded: YES □ NO □
QA OFFICER: _______________ DATE & TIME:________________ REMARKS: _________________________________
TEAM LAYOUT SHEET AT PACKING STAGE

Packing Start Time: Packing Closing Time:
Packing Starting Date: Packing Completion Date:
Name Time In Time Out Total Time

Page 40 of 47

Product Code: --
Revision no: 00
Checked By: ___________________ Verified by: _____________________

Belt Incharge Production Pharmacist
IN-PROCESS CONTROL SHEET FOR PACKING
Date: ____________Start Time: ______________Close Time _____________
Status
YES : ✔ NO : X
Bulk inspection Unit carton information Shippers packing
Presence of Retained
Date Time Mfg. Exp. No of Labeling, Checked by
Blisters Leaflet Unit Cartons Batch No MRP (Rs.) Leaflet Samples
Date Date Packs Sealing
Page 41 of 47

Product Code: --
Revision no: 00
REMARKS: ________________________________________________________________________________
Packing Pharmacist: _____________ Q.A. Officer: _______________
NOTE: 1) In process entries are taken after every 45 minutes by QA and Production alternatively.
2) QA officer will use Black ball point while Production officer will use Blue ball point.
CERTIFICATE OF ANALYSIS
General Tablet Section Finished
Date: Time: Sampled By Quantity QA Officer (Sign)

Sample Receiving Sample Receiving Sample Release Sample Release Time: QC Reference
Date: Time: Date: No.

Physical Appearance Red Color Round Shape film Coated Tablet with engraved cut line on one side
Identification:
Width 8±0.04mm
Thickness 5±0.04mm
Dissolution Dissolution in 900ml water for 45 minutes: NLT 80% (Q)
Remarks: _________________________________________________________________________
Page 42 of 47

Product Code: --
Revision no: 00
Checked By: ________________ Verified By: _______________ Approved By: ______________

QC Analyst Q.C. Manager QA Manager
Page 43 of 47

Product Code: --
Revision no: 00
FINISHED GOODS TRANSFER NOTE

For Commercial: Pack Size: 2*10’s / unit carton
No of shippers Checked By Received by
Date Mfg. Date Exp. Date Total Quantity Production
Full Part Box Production Officer QA Officer Officer
Grand Total
Remarks: __________________________________________________________________________
Verified By: ____________
Section Incharge Production Manager Store Incharge
PACKING MATERIALS RECONCILIATION FOR COMMERCIAL

Date__________
Page 44 of 47

Product Code: --
Revision no: 00
Quantity Quantity Quantity Quantity Received

Description
Issued Used Rejected Returned By
PVC Foil
Printed Foil
Unit Carton
Leaflet
Outer Shipper
Packing Tape
Remarks: __________________________________________________________________________________
Section Incharge Production Manager Store Incharge QA Manager
Page 45 of 47

Product Code: --
Revision no: 00
BATCH RECONCILIATION
Sr. # Quantity Produced (Total Packs)

1 Commercial Packs
2 QA Retained Samples
3 Left Over (If Any With Adjustment)
4 Theoretical Yield
5 Practical Yield
6 Process Wastage
7 Date Of Completion
Remarks:___________________________________________________________________________________________
___________________________________________________________________________________________________
___________________________________________________________________________________________________
Checked By: ______________ Reviewed By: _________________ Approved By: _____________

Section Incharge Production Manager QA Manager
Page 46 of 47

Product Code: --
Revision no: 00
DESTRUCTION NOTE
IN PROCESS MATERIAL REJECTION

Sign.
Quantity Reason for
Date Material QA
Destroyed destruction Production Officer
Officer
PVC Foil
Alu-Alu foil
Unit Cartons
Leaflets
Remarks: _________________________________________________________________________
Checked By: ______________ Reviewed By: _________________ Approved By: ___________

Section Incharge Production Manager QA Manager
Page 47 of 47

Methylbrill 500mcg Tablet T-043

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BRIELL Pharmaceuticals

BATCH MANUFACTURING RECORD

Product Name: METHYLBRIL 500mcg Tablet

3 Batch Size: 4000 Tabs . .

5 Expiry Date: 05-2024 .

6 Shelf Life: 24Months .

7 Pack Size: 2*10s

9 BMR Issued Date:.

10 BMR Submission Date:

Reviewed By: ____________________ Approved By:________________

PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

BMR COMPLIANCE CHECKLIST

PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

MASTER FORMULATION FOR RAW MATERIAL

Each Tablet Standard Batch

2. Lactose Monohydrate 43 0.172

4. Avicel 102 88 0.352

5. PVP K-30 4.3 0.017

6. Mag. stearate 1.5 0.006

7. Primojel 5.5 0.022

8. Talcum 5.2 0.021

9. IPA 0.006 0.024

10. Ethroycin Red Color 2.63 0.0105

11. Coating Material 26.30 0.1052

12. IPA 0.30 0.0012

13. Titanium Dioxide 3.86 0.0154

14. PEG 6000 87.60 0.3504

PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

CALCULATION OF ACTIVE PHARMACEUTICAL INGREDIENT (API)

Assay of API (Potency): (as such)

Overage of API: _______________________

Label Claim: 500mcg per Tablet

Weight of API per tablet( mcg) = 100_ x Label Claim = mcg/Tablet

Weight of API per batch(kg) = mcg/Tablet x batch size = kg/batch size

Total Weight of API (g): __________kg________________________

Remarks (if any): __________________________________________

PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

MANUFACTURING ORDER For Production Use

PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

MANUFACTURING ORDER For Warehouse Use

PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

LINE CLEARANCE CHECKLIST FOR DISPENSING

PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

VERIFICATION OF DISPENSED RAW MATERIALS

PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

LIST OF EQUIPMENT USED DURING MANUFACTURING

6 Rotary tablet press ZP-17 BM/R&D/006

7 Dust collector -----

8 Double jacket coating mixer BM/R&D/007

9 Coating pan SS BM/R&D/008

10 ALU-PVC blister machine 4001

11 LASER Jet printer 4003

12 Conveyer belt 4002

PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

LINE CLEARANCE CHECKLIST FOR GRANULATION

STANDARD MANUFACTURING PROCEDURE FOR GRANULATION

PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

Performed Checked By Verified

PRODUCT NAME: METHYLBRIL 500mcg TABLET Doc no: PR/BMR/001

Reviewed By: ____ Approved By:

Total Weight of API (g): kg______________

Total Sieving Time: Date:__

Total Mixing Time: Date:__

Performed by: _Checked by: Verified by: __

Total Weight received: _ Date: ___________

Recieved by: ____ Checked by: _

Performed By: ______ Checked by: _ Approved by: ______

QC Analyst _____ QC Manger

Production Officer QA Officer :

Checked by: ______ Verified by:

Theoretical weight of grains:___ Kg Actual weight of compressed tablets:_ Kg

% Yield = _ % % Wastage = %

Performed by: Checked by: Verified by: __

Total Weight received: _ Date: ____________

Performed by: _ Checked by:

Performed By: Checked by: Approved by:

% Yield = _ % % Wastage = %

Performed by: Checked by: Verified by: __

Total Weight received: _ Date: ____________

Performed by: _ Checked by: