ABCD. Pharmaceuticals R&D BATCH RECORD Tablets, fluid bed dryer, coating.

etc and strength and dosage form Batch Size: ????? Kg/Gm
Written By: Date:

Project Number: RD???? Batch Number: ????????

Date: Approved By: Date:

Checked By:

WEIGHING
MASTER FORMULA Before Beginning Weighing Operation, The Area, Equipment, Utensils And Ingredients Must Be Checked For Compliance With SOP And cGMP.
Performed By: Date Checked By Date

S. No.

(mg/g)

Ingredients

RM Lot #

Theoretica l kg

SC #

WHD By

CHK By

Date

400

Abcd

1111

3.600

1000

Total

9.000

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ABCD. Pharmaceuticals R&D BATCH RECORD Tablets, fluid bed dryer, coating.etc and strength and dosage form Batch Size: ????? Kg/Gm
STEP #

Project Number: RD???? Batch Number: ????????

PERFORMED BY
Initial & Date

MANUFACTURING PROCEDURE Before beginning the BLENDING OPERATION, the area (room no.___________), equipment, and utensils must be checked for compliance with Standard Operating Procedures and Current Good Manufacturing Practices. Also check and verify that all cleaning procedures have been followed and all log book entries have been made.

CHECKED BY
Initial & Date

1.

Verified By:_________________________ Date: _________________

2.

Check that all ingredients are in compliance with Standard Operating Procedures and Current Good Manufacturing Practices.

Verified By:_________________________ Date: __________________

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ABCD. Pharmaceuticals R&D BATCH RECORD Tablets, fluid bed dryer, coating.etc and strength and dosage form Batch Size: ????? Kg/Gm
STEP #

Project Number: RD???? Batch Number: ????????

PERFORMED BY
Initial & Date

MANUFACTURING PROCEDURE Screen Item #) through a # 30 mesh SS Screen and transfer to the bowl of the HIGH SHEAR MIXER/GRANULATOR (Equip. # __________). Rinse the bag containing ?????? with one scoop of item # 2 ????? after passing through SS screen # 30 and transfer to the bowl. Screen remaining Item # 2 ( ???????) through a # 30 mesh SS Screen and transfer to the bowl of the HIGH SHEAR MIXER/GRANULATOR (Equip. # _______ ).

CHECKED BY
Initial & Date

3.

4.

5.

Set the timer for the HIGH SHEAR MIXER/GRANULATOR (SM-50) for THREE (3) MINUTES and mix using the paddles set at Low speed (185 rpm) with the choppers turned off. TIME STARTED: Hr._______ Min. __________ TIME STOPPED: Hr._______ Min. __________ Screen Item # 3 (?????) through a # 30 mesh SS Screen and transfer to the bowl of the HIGH SHEAR MIXER/GRANULATOR (SM-50) (Equip. # _______ ).

6.

7.

Screen Item # 4 ( ???????) through a # 30 mesh SS Screen and transfer to the bowl of the HIGH SHEAR MIXER/GRANULATOR (SM-50) (Equip. # _______ ).

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ABCD. Pharmaceuticals R&D BATCH RECORD Tablets, fluid bed dryer, coating.etc and strength and dosage form Batch Size: ????? Kg/Gm Project Number: RD???? Batch Number: ????????

STEP #

MANUFACTURING PROCEDURE Screen Item # 5 (?????) through a # 30 mesh SS Screen and transfer to the bowl of the HIGH SHEAR MIXER/GRANULATOR (SM-50) (Equip. # _______ ). Set the timer for the HIGH SHEAR MIXER/GRANULATOR (SM-50) for THREE (3) MINUTES and mix using the paddles set at Low speed (185 rpm) with the choppers turned off. TIME STARTED: Hr._______ Min. __________ TIME STOPPED: Hr._______ Min. __________ Withdraw TEN (10) Blend CU samples (1X to 3X of unit dose i.e. 125mg -375 mg) after 3 minutes of blending. DOSATOR SIZE: ____________ Total Weight of samples:_____________

PERFORMED BY
Initial & Date

CHECKED BY
Initial & Date

8.

9.

10.

Screen Item # 6 ( ?????) through a # 30 mesh SS Screen and transfer to the bowl of the HIGH SHEAR MIXER/GRANULATOR (SM-50) (Equip. # _______ ).

Page 4 of 6

ABCD. Pharmaceuticals R&D BATCH RECORD Tablets, fluid bed dryer, coating.etc and strength and dosage form Batch Size: ????? Kg/Gm
STEP #

Project Number: RD???? Batch Number: ????????

PERFORMED BY
Initial & Date

MANUFACTURING PROCEDURE

CHECKED BY
Initial & Date

11.

Set the timer for the HIGH SHEAR MIXER/GRANULATOR (SM-50) for THIRTY (30) SECONDS and mix using the paddles set at Low speed (185 rpm) with the choppers turned off. TIME STARTED: Hr._______ Min. __________ Sec.__________ TIME STOPPED: Hr._______ Min. __________ Sec.__________ Withdraw TEN (10) Blend CU samples (1X to 3X of unit dose i.e. 125mg -375 mg) after 30 seconds of blending. DOSATOR SIZE: ____________ Total Weight of samples:_____________

12.

Set the timer for the HIGH SHEAR MIXER/GRANULATOR (SM-50) for THIRTY (30) SECONDS and mix using the paddles set at Low speed (185 rpm) with the choppers turned off. TIME STARTED: Hr._______ Min. __________ Sec.__________ TIME STOPPED: Hr._______ Min. __________ Sec.__________ Withdraw TEN (10) Blend CU samples (1X to 3X of unit dose i.e. 125mg -375 mg) after 30 seconds of blending. Note: See attachment 1 DOSATOR SIZE: ____________ Total Weight of samples:_____________

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ABCD. Pharmaceuticals R&D BATCH RECORD Tablets, fluid bed dryer, coating.etc and strength and dosage form Batch Size: ????? Kg/Gm Project Number: RD???? Batch Number: ????????

STEP #

MANUFACTURING PROCEDURE

PERFORMED BY
Initial & Date

CHECKED BY
Initial & Date

13.

Discharge the blend into clean, tared, properly labeled, double polyethylene lined containers. Weigh and record the weights and calculate the yield and accountability using the table given below: NO. OF CONTAINERS:_____________ SCALE NO:_____________ A B C D E F G THEORETICAL WEIGHT ACTUAL WEIGHT WASTE SAMPLES TOTAL ACCOUNTED FOR ( B + C + D ) TOTAL % ACCOUNTED FOR [( E A ) x 100] ACTUAL % NET YIELD [( B A ) x 100] 9.000 kg kg kg kg kg % %

ACCOUNTABILITY: 98.0% - 101.0% of the Theoretical Weight must be accounted for (F). Do not proceed if there is a deviation from this percentage without reporting to Production and Quality Assurance Management and an explanation/investigation of the deviation must be recorded on the reverse side of this page. PERFORMED BY: _____________________DATE: ______________ VERIFIED BY: _______________________ DATE:______________ 14. Transfer the blend to the appropriate staging area

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