Batch Manufacturing Report

Product Name: HYDROCORTISONE TABLETS USP 10mg STRIDES PHARMA SCIENCE LIMITED - F1 Bangalore, India Product Code: 2006648 | Batch Size: 750,000 ea | Process Order Number: 200664830

Batch Manufacturing Report Page 1 of 73 Report Generated On: 03/11/2021 10:13:36

Version: 1.0.3

Once printed this document shall be considered as Uncontrolled

Batch Manufacturing Report

Cover Page

Process Order Number: 200664830

Batch Number: Same as Process Order Number.

Batch Type: Routine

Plant Code: 1006

MFR Number: R03

Manufacturing Date: Oct.2021

Expiry Date: Sep.2023

Shelf Life (in months): 24.0 months, from the date of manufacturing

Label Claim: Each Tablet contains Hydrocortisone 10mg

Product Description: White to off-white oval tablets debossed on one side with a bisect and other side with 'H10'

Batch Size: 750,000 ea

Product: (2006648) HYDROCORTISONE TABLETS USP 10mg

Recipe: (MR_2006648_HYDROCORTISONE) Master recipe for Hydrocortisone Tablets

Recipe Version: 31

Recipe Number: BMP/2006648U1460/R5,BOM/2006648U1460/R1

Batch Start: 27/10/2021



Version: 1.0.3


Batch End:

Market: US



Version: 1.0.3


Table of Contents Review Signatures

Areawise Lot Details

Attachments

Bill of Materials

Executed Steps

Environmental Summary

Job Allocation and Deallocation Summary

Sieve/Screen Summary

Process Execution

In-Process Sample Collection Summary

In-Process Test Result Summary

QC Sample Summary

Equipment Usage Summary

Break Down Summary

Deviation and Notification Summary

Yield Summary

Label Summary



Version: 1.0.3


Final Batch Review Signatures

Not Received

Order Close Signature

Not Received

Areawise Lot Details

Manufacturing Operation Area Number of Lots Lot Number

BLENDING BLENDING-5 1 1

COMPRESSION COMPRESSION-5 1 1

INSPECTION INSPECTION-2 1 1



Version: 1.0.3


Attachments

N/A



Version: 1.0.3


Executed Steps

1 Procedure: Dispensing Area Line Clearance

1.1 Unit Procedure: Dispensing Area Line Clearance

1.1.1 Operation: Special and General Instructions

1.1.1.1 Special Instructions

Read the following special instructions carefully.

Sr.No. Product Special Instructions

1 API is light sensitive, Dispensing of API (only), manufacturing process and packing to be carried out under monochromatic light.

2 API is Teratogenic, possible risk to unborn child, hence Pregnant women should not be allowed to work with this product..

3 API to be dispensed in double lined polyethylene bags placed in triple laminated aluminium bags and stored along with 4 numbers of Desiccants placed in between the two polyethylene bags and the triple laminated bags to be thermo-sealed.

4 Blend,Compressed and inspected tablets also to be stored in double lined polyethylene bags and placed in triple laminated aluminium bags and stored along with 4 numbers of Desiccants placed in between the two polyethylene bags and the triple laminated bags to be thermo-sealed.

5 This product shall be manufactured as per OEB-3 Procedure no.: EMS 8.1-06-01.

6 Personal Protective Equipment such as goggles, HFE with P3 cartridge and Gloves should be used.

7 Process waste generated during manufacturing shall be handled as per Procedure. F1/EH/001.

8 Static discharge clip to be connected during Sifting process.

9 Riveted or Anti-static sieves to be used for sifting.

10 Equipment body earthing (double earthing) to be ensured.

11 Continuity of earthing (double earthing) from body to be ensured.

General Instructions:

Sr.No. General Instructions

1 Persons shall wear appropriate PPE’s while handling the product.

2 Label all in-process containers or bags with details of material and stage of operation.

3 Wear Latex gloves during drug handling as required.

4 The product waste generated at each stage shall be handled as per SOP: GQA/046.

5 Any case of non-compliance observed, throughout the process shall be handled as per SOP: GQA/022.

6 Ensure that all work station doors are closed at all times during processing.

7 Do not expose the R.M., semi-finished and finished product to undue light and open atmosphere.

8 Store the product in tightly closed container.



Version: 1.0.3


9 Ensure that all instrument / equipments used in manufacturing are in calibrated / validated state.

10 During line clearance, production and QA shall ensure environmental condition (temperature, pressure and humidity [as applicable]) are within the specified limits.

11 Ensure environmental condition is as per SOP: F1/QA/004.

12 Ensure differential pressure within limit during the process.

Click Execute Icon after reading above instruction. Signatures required: SUPERVISOR

Start Date & Time 27/10/2021 16:20:16 End Date & Time 27/10/2021 16:20:29 Activity completed by Supervisor - teamleasesanjeevm (Sanjeevannara Manikantha)

27/10/2021 16:19:53 27/10/2021 16:20:29 Supervisor - Sanjeevannara Manikantha teamleasesanjeevm

Operation Start Date & Time Operation End Date & Time Operation completed by (Name) Signature

1.1.2 Operation: Line Clearance for Dispensing Area

1.1.2.1 Scan the area

Scan the barcode affixed on the area to initiate the line clearance activity.

Identification No. DISPENSING AREA 02-API

1.1.2.2 LAF set parameters

Parameter Set Value UOM

Fine Filter Limit: 30 to 60 PA

Hepa Filter Limit: 60 to 110 PA

Pre Filter Limit: 15 to 40 PA

Velocity Limit: 72 to 108 FPM

1.1.2.3 Process Values

Parameter Value UOM

Velocity 0 FPM



Version: 1.0.3


1.1.2.4 Line Clearance by Stores

Click on the Hyperlink below to open Area Line Clearance checklist. Check for all the points mentioned in the checklist for its compliance. Non Serial Line Clearance checklist Click Execute Icon when check for all the points in the checklist is completed. SOP Reference: Refer Line Clearance SOP: F1/QA/010 ,Area Cleanliness SOP: F1/WH/004 and eBMR Execution Manual No: UM-03EBMR-001


Line Clearance Type Non-Serial

Previous Process Order Number 7248079

Previous Product Code 2002909

Previous Product Name Mycophenolat Mofetil tab 500mg-FC-US-ALT

Parameters UOM Low Limit High Limit Actual Value Verification Status

Temperature oC 20.0 24.0 22.0,22.0 Complies

Relative Humidity %RH 0 50 35,35 Complies

Differential Pressure Values mmWc 1 3 2.0,1.5,1.8,1.8,1.5,1.5,1.5 Complies

Signatures required: SUPERVISOR




Comments

Step Name Comment Type Comment Date User

User Not qualified for Line clearance. [ 1.1.1.3.4.21 ] Active Step Change OQ 27/10/2021 16:34:58

teamleasesanjeevm (Sanjeevannara Manikantha)

1.1.3 Operation: Line Clearance by QA for Dispensing Area

1.1.3.1 Area line clearance

Click on the Hyperlink below to open Area Line Clearance checklist. Check for all the points mentioned in the checklist for its compliance. Non Serial Line Clearance checklist



Version: 1.0.3


Click Execute Icon when check for all the points in the checklist is completed. SOP/WI Reference: Refer Line Clearance SOP: F1/QA/010 ,Area Cleanliness SOP: F1/WH/004 and eBMR Execution Manual No: UM-03EBMR-001



Previous Process Order 7248079


Previous Product Name Mycophenolat Mofetil tab 500mg-FC-US-ALT

Signatures required: QA

Start Date & Time 27/10/2021 16:38:45 End Date & Time 27/10/2021 16:39:27 Activity completed by QA - teamleasesanjeevm (Sanjeevannara Manikantha)

1.1.3.2 Equipment line clearance summary.

QA Line clearance for the following is complete.

Area Line Clearance Status

DISPENSING AREA 02-API Complies

SOP Reference : Refer Line Clearance SOP: F1/QA/010 ,Area Cleanliness SOP: F1/WH/004 and eBMR Execution Manual No: UM-03EBMR-001 Click Execute Icon to go to the next step.

27/10/2021 16:37:37 27/10/2021 16:39:47 QA - Sanjeevannara Manikantha teamleasesanjeevm

Operation Start Date & Time

Operation End Date & Time Operation completed by (Name) Signature

Comments


User Not Qualified for Line clearance [ 1.1.1.3.5.21 ] Active Step Change OQ 27/10/2021 16:38:35


1.1.4 Operation: Silica gel Sachets Addition

1.1.4.1 Display allocated containers

Following are the containers/polybag details of Silicagel sachets added.

Container No./Bag no Silica gel sachets Quantity

200664830_1040601_S4 4



Version: 1.0.3


Click Execute Icon to continue to next step. Number of Silicagel sachets Added:4.00 Leftover quantity of Silicagel Sachets:196 Destroy the remaining quantity of the silicagel sachets or carry forward for the next operation. Signatures required: SUPERVISOR and QA

Start Date & Time 28/10/2021 10:14:38 End Date & Time 28/10/2021 10:16:48 Activity completed by Supervisor - teamleasesanjeevm (Sanjeevannara Manikantha) , QA - qam (Test QA manager)

27/10/2021 16:40:06 28/10/2021 10:16:48 Supervisor - Sanjeevannara Manikantha,

QA - Test QA manager teamleasesanjeevm, qam




Version: 1.0.3


2 Bill of Materials

Material Description

Material Code

Stage ID

UOM Std Qty. Lot

Cont. No. / Polybag

S.R. No. Tare Wt.

Net Wt. Gross Wt.

Potency (%w/w)

Weighed By Dispensed On

SILICAGEL SACHET-[25G]

1005303 1 ea 200.000 1 1 1.000 200.000

201.000

100.000 Not Required 27/10/2021 18:10:10

TRIPLE LAMINATED BAG-[30INCH X 50INCH][3 SIDE SEAL BAG]

1013895 2 ea 50.000 1 1 1.000 50.000 51.000 100.000 Not Required 27/10/2021 18:10:10

MCC BP-PhEur-USNF-PH101

1000542 3 kg 62.025 1 1 1.000 62.025 63.025 100.000 Not Required 27/10/2021 18:10:10

Colloidal Sillicon DioxideNF(CabosilM5P)

1028577 4 kg 0.469 1 1 1.000 0.469 1.469 100.000 Not Required 27/10/2021 18:10:10

HYDROCORTISONE [MICRONIZED] USP

1040601 6 kg 7.500 1 1 1.000 7.500 8.500 100.000 Not Required 27/10/2021 18:10:10

LACTOSE MONOHYDRATE

1026776 8 kg 115.631 1 1 1.000 115.631

116.631

100.000 Not Required 27/10/2021 18:10:10

MAGNESIUM STEARATE USP/NF,BP/Ph.Eur

1028683 9 kg 1.875 1 1 1.000 1.875 2.875 100.000 Not Required 27/10/2021 18:10:10



Version: 1.0.3


3 Procedure: Gross Weight Verification for Blending Stage Materials

3.1 Unit Procedure: Gross weight verification

3.1.1 Operation: Gross Weight Verification


Scan the barcode affixed to the area to perform dispensed raw material gross weight verification.

Identification No. BLENDING-5

3.1.1.2 Scan scale for weighing the raw material containers

Scan the barcode affixed to the weighing scale for dispensed raw material gross weight verification.

Identification No. SAL/KRSG/TAC/EWS/05/049

3.1.1.3 Gross weight verification complete for current stage

Gross weight verification complete for below materials. Click on Execute Icon to continue to next activity.

Material Code

Material Description UOM Standard Quantity

Stage ID

Lot Number

Container Barcode Dispensed Gross Weight

Verified Gross Weight

1026776 LACTOSE MONOHYDRATE kg 115.631 8 1 200664830_1026776_S5 116.631 116.630

1028577 Colloidal Sillicon DioxideNF(CabosilM5P)

kg 0.469 4 1 200664830_1028577_S7 1.469 1.469

1000542 MCC BP-PhEur-USNF-PH101 kg 62.025 3 1 200664830_1000542_S6 63.025 63.025

1028683 MAGNESIUM STEARATE USP/NF,BP/Ph.Eur

kg 1.875 9 1 200664830_1028683_S8 2.875 2.875

1040601 HYDROCORTISONE [MICRONIZED] USP

kg 7.500 6 1 200664830_1040601_S4 8.500 8.500

Signatures required: OPERATOR

Start Date & Time 28/10/2021 10:32:18 End Date & Time 02/11/2021 17:21:08 Activity completed by Operator - teamleasesanjeevm (Sanjeevannara Manikantha)

28/10/2021 10:18:11 02/11/2021 17:21:08 Operator - Sanjeevannara Manikantha teamleasesanjeevm




Version: 1.0.3


Comments


Keep container weight from scale [ 1.1.3.1.2.15 ] Force Step OQ 28/10/2021 10:25:15












Version: 1.0.3


4 Procedure: Blending

4.1 Sieves / Screens Summary

Lot Number

Sieve/Screen ID Sieve/Screen Size

Integrity Check – Pre

Checked By – Pre Pre Check Date

Integrity Check – Post

Checked By - post Post Check Date

1 T/30#/45/14 30 Satisfactory teamleasesanjeevm (Sanjeevannara Manikantha)

28/10/2021 13:00:30

Satisfactory teamleasesanjeevm (Sanjeevannara Manikantha)

28/10/2021 13:10:30


28/10/2021 13:12:14


28/10/2021 13:17:46


28/10/2021 13:39:52


28/10/2021 15:18:52


28/10/2021 15:28:57


28/10/2021 15:39:48


28/10/2021 15:43:21


28/10/2021 15:51:16


28/10/2021 16:25:08


28/10/2021 16:30:53


28/10/2021 16:34:25


28/10/2021 16:44:07


28/10/2021 16:48:13


28/10/2021 16:53:52

4.2 Unit Procedure: Blending Sifting

4.2.1 Operation: Silicagel Removal

4.2.1.1 Display silicagel removed Containers/Polybag table

Following are the containers details for silicagel sachets are removed.


200664830_1040601_S4 4



Version: 1.0.3


Total Number of silicagel sachets removed:4.00 Destroy the quantity of the silica gel sachet removed from the containers/polybag. Signatures required: SUPERVISOR and QA


28/10/2021 12:55:38 29/10/2021 15:15:48 QA - Test QA manager, Supervisor -

Sanjeevannara Manikantha qam, teamleasesanjeevm


4.2.2 Operation: Sifting material step1, Lot-1

4.2.2.1 Fix the sieve

Sifter ID: TAC/SFT/105 Sieve ID: T/30#/45/14 (# 30 sieve) Fix the Sieve to the Sifter.

4.2.2.2 Material Sifting

Sift the material as per below instructions: Sifting Type : SINGLE STEP SIFTING Material details:

Material Code Material Description Lot Number Stage Id Quantity UOM Number of Containers

1000542 MCC BP-PhEur-USNF-PH101 1 3 62.025 kg 1

Special Instructions: NONE Select Options

Sr. No. Option Description

1 Unloading Preparation of Empty container which is required to collect the sifted material.

2 Loading To perform Sifting activity.

3 Exit To exit after completion of Sifting activity.



Version: 1.0.3


Selection EXIT

4.2.2.3 Container details

Sr.No. Material Description Container Barcode Stage ID Lot Number

1 Sifted Material CON/024 3 1







Sift the material as per below instructions: Sifting Type : CO SIFTING Material details:


1028577 Colloidal Sillicon DioxideNF(CabosilM5P) 1 4 0.469 kg 1

WIP Sifted Material 1 3 NA NA 1








Version: 1.0.3


Selection EXIT






4.2.4 Operation: Meterial splitting, Lot-1

4.2.4.1 Split Container weighing details

Container Weighing details Total weight of Split Quantity5.00 kg

Sr.No. Material Description ContainerBarcode UOM Stage ID Lot Number Net Weight Gross Weight Tare Weight

1 Splitted Material CON/026 kg 5 1 5.000 7.000 2.000

4.2.4.2




Comments


Read the container weight from balance (gross weight) [ 1.1.4.15.13.35 ]

Force Step OQ 28/10/2021 13:36:00




Sifter ID: TAC/SFT/105



Version: 1.0.3


Sieve ID: T/30#/45/14 (# 30 sieve) Fix the Sieve to the Sifter.




1040601 HYDROCORTISONE [MICRONIZED] USP 1 6 7.500 kg 1

WIP Sifted Material 1 4 NA NA 1






Selection EXIT











Version: 1.0.3





WIP Splitted Material 1 5 5.000 kg 1






Selection EXIT













Version: 1.0.3



1026776 LACTOSE MONOHYDRATE 1 8 115.631 kg 1






Selection EXIT















Version: 1.0.3


1028683 MAGNESIUM STEARATE USP/NF,BP/Ph.Eur 1 9 1.875 kg 1






Selection EXIT






4.3 Unit Procedure: Line clearance for Blending

4.3.1 Operation: Production area line clearance




4.3.1.2 Area Line Clearance

Click on the Hyperlink below to open Area Line Clearance checklist. Check for all the points mentioned in the checklist for its compliance. Non Serial Line Clearance checklist Click Execute Icon when check for all the points in the checklist is completed. SOP Reference: Refer Line Clearance SOP: F1/QA/010 , Area Cleanliness SOP: F1/PR/005 and eBMR Execution Manual No: UM-03EBMR-001




Version: 1.0.3





Previous Product Name Prednisone Tab 25mg -Aspen

Area Environmental Conditions:


Temperature oC 20.0 24.0 22.0 Complies

Relative Humidity %RH 0 50 31 Complies

Differential Pressure with respect to Corridor mmWc 1 2 1.5 Complies





Comments


User Not qualified for Line clearance. [ 1.1.4.6.5.22 ] Active Step Change user not qualified changes current step performing to continue the OQ execution

28/10/2021 11:35:40


4.3.2 Operation: Production equipment line clearance

4.3.2.1 Line clearance for all the equipments is done.

Area: BLENDING-5 Production Line Clearance for all equipments is completed. Fixed Equipment:

Fixed Equipment Type

Fixed Equipment ID

Fixed Equipment Name Line Clearance Status

Previous Product Code

Previous Product Name Previous Process Order Number

BLENDER TAC/BIN/179 Tablet Block - Column Mounted conta Blender

Satisfactory

2004073 Oxybutynin Chloride Tabs USP 5mg-US

2004073_02

Movable Equipment:



Version: 1.0.3


Movable Equipment Type

Movable Equipment ID

Movable Equipment Name

Line Clearance Status



BLENDER BIN-750L

TAC/BIN/179/750/01 TAC/BIN/179 BLENDER BIN-750L

Satisfactory

2002919 Artemether and Lumefan tab-20/120mg Sequent

200291900

SIFTER TAC/SFT/105 Tablet Block - Vibratory Sifter [550 mm]

Satisfactory


7229153

Inform QA for initiating the Line clearance activity and Click Execute Icon. Signatures required: SUPERVISOR




Comments




Supervisor to Check as per Equipment Checklist [ 1.1.4.6.7.16 ]

Active Step Change Previous PO, product code updated

28/10/2021 12:19:12


4.3.3 Operation: QA line clearance


Click on the Hyperlink below to open Area Line Clearance checklist. Check for all the points mentioned in the checklist for its compliance. Non Serial Line Clearance checklist Click Execute Icon when check for all the points in the checklist is completed. SOP/WI Reference: Refer Line Clearance SOP: F1/QA/010 ,Area Cleanliness SOP: F1/PR/005 and eBMR Execution Manual No: UM-03EBMR-001





Previous Product Name Prednisone Tab 25mg -Aspen



Version: 1.0.3



Start Date & Time 28/10/2021 12:29:12 End Date & Time 28/10/2021 12:30:28 Activity completed by QA - qam (Test QA manager)




BLENDING-5 Complies

Fixed Equipment:


Fixed Equipment ID




BLENDER TAC/BIN/179 Tablet Block - Column Mounted conta Blender

Satisfactory

2004073 Oxybutynin Chloride Tabs USP 5mg-US

2004073_02

Movable Equipment:







BLENDER BIN-750L

TAC/BIN/179/750/01 TAC/BIN/179 BLENDER BIN-750L

Satisfactory


200291900

SIFTER TAC/SFT/105 Tablet Block - Vibratory Sifter [550 mm]

Satisfactory


7229153

SOP Reference : Refer Line Clearance SOP: F1/QA/010 ,Area Cleanliness SOP: F1/PR/005 and eBMR Execution Manual No: UM-03EBMR-001 Click Execute Icon to go to the next step.

28/10/2021 12:23:53 28/10/2021 12:30:55 QA - Test QA manager qam



Comments




4.4 Unit Procedure: Empty container verification



Version: 1.0.3


4.4.1 Operation: Empty container verification

4.4.1.1 Container Verification

Number of Containers Verified for cleanliness: 10 List of Containers Verified:

CON/024,CON/025,CON/026,CON/027,CON/028,CON/029,CON/030,CON/032,CON/033,CON/018

Verified by : teamleasesanjeevm (Production) and teamleasesanjeevm (QA)







4.5 Unit Procedure: Blending

4.5.1 Operation: Bin E_IN_PRODUCTION start

4.5.1.1 Scan the peristaltic pump/Diaphragm Pump to be used

Scan the barcode affixed on the Blender Bin to be used.

Identification No. TAC/BIN/179/750/01

28/10/2021 15:53:00 28/10/2021 15:54:26 System Account System verification


4.5.2 Operation: Load container 1

4.5.2.1 Scan the barcode of the Target Equipment

Scan the barcode affixed on BLENDER to load material into it.



Version: 1.0.3


Identification No. TAC/BIN/179

4.5.2.2 Confirm all containers are loaded.

Click Execute Icon to confirm all containers are loaded.

Material Code Material Description Lot Number Stage Id Number of Containers

WIP Sifted Material 1 6 1






4.5.3 Operation: first Blending

4.5.3.1 Set the parameters in PLC

Set the following input parameters in PLC to operate Blender: Click Execute Icon to verify that PLC parameters are set correctly.


Blending Time 5 Minutes

Blender Speed 12 RPM

4.5.3.2 Start Blender

Start the Blender in PLC. Select "Get Actual Parameters" to view the process parameters. Select "Blending Complete" and click the Execute Icon to continue the activity. Click Execute Icon when blending time is complete. Signatures required: OPERATOR

Selection Blending Complete




Version: 1.0.3


4.5.3.3 Process Parameters (Actual)

Equipment Code TAC/BIN/179

Data Capture Interval in min 1

Parameter Blender Speed (RPM) Blending Time (Minutes)

Time Stamp

28/10/2021 16:07:21 12 8

28/10/2021 16:08:21 12 9

28/10/2021 16:09:21 12 10

28/10/2021 16:10:21 12 11

28/10/2021 16:11:21 12 12

28/10/2021 16:12:09 12 13









WIP Pre Lubricated Granules 1 12 2







Version: 1.0.3



Selection EXIT























Version: 1.0.3


Selection EXIT









4.5.6 Operation: Load container2














Version: 1.0.3


4.5.7 Operation: Second Blending







Start the Blender in PLC. Select "Get Actual Parameters" to view the process parameters. Select "Blending Complete" and click the Execute Icon to continue the activity. Click Execute Icon when blending time is complete. Signatures required: OPERATOR




Start Date & Time 28/10/2021 17:04:04 End Date & Time 28/10/2021 17:06:59 Activity completed by - teamleasesanjeevm (Sanjeevannara Manikantha)





Time Stamp

28/10/2021 17:01:52 0 3

28/10/2021 17:02:52 0 3

28/10/2021 17:03:52 0 3

28/10/2021 17:04:52 0 3

28/10/2021 17:05:00 0 3



Version: 1.0.3




4.5.8 Operation: Load container2












4.5.9 Operation: Second Blending







Start the Blender in PLC. Select "Get Actual Parameters" to view the process parameters. Select "Blending Complete" and click the Execute Icon to continue the activity.



Version: 1.0.3


Click Execute Icon when blending time is complete. Signatures required: OPERATOR







Time Stamp

28/10/2021 17:14:34 0 3

28/10/2021 17:15:34 0 3

28/10/2021 17:16:34 0 3

28/10/2021 17:17:34 0 3

28/10/2021 17:18:34 0 3

28/10/2021 17:19:20 0 3



4.5.10 Operation: Silicagel Addition




CON/024 4

CON/025 4

CON/026 4

CON/027 4

CON/028 4

CON/029 4

CON/030 4

Click Execute Icon to continue to next step.



Version: 1.0.3


Number of Silicagel sachets Added:28.00 Leftover quantity of Silicagel Sachets:168 Destroy the remaining quantity of the silicagel sachets or carry forward for the next operation. Signatures required: SUPERVISOR and QA


29/10/2021 11:40:26 29/10/2021 14:58:21 QA - Test QA manager, Supervisor - Sanjeevannara

Manikantha qam, teamleasesanjeevm


Comments


Read the weight from scale [ 1.1.4.11.31.51 ] Force Step OQ 29/10/2021 11:57:37














4.5.11 Operation: Product weighing

4.5.11.1 Scan scale for weighing the product containers

Scan the barcode affixed on weighing scale for weighing the container.



Version: 1.0.3



4.5.11.2 Container Weighing details

Container Weighing details Total weight of lot is 186.480 kg


1 Lubricated Granules CON/030 kg 19 NA 26.640 28.640 2.000







29/10/2021 12:58:00 29/10/2021 14:50:56 - Sanjeevannara Manikantha teamleasesanjeevm




Version: 1.0.3


Recipe Comments

Section Name Comment Type Comment Date User

Product weighing Force Transition OQ 29/10/2021 13:31:53


Comments


Keep the IPC on balance & confirm to record the weight [ 1.1.4.11.22.9 ]

Force Step OQ 29/10/2021 13:09:45



Force Step OQ 29/10/2021 13:11:23



Force Step OQ 29/10/2021 13:15:17



Force Step OQ 29/10/2021 13:16:59



Force Step OQ 29/10/2021 13:18:26



Force Step OQ 29/10/2021 13:37:30



Force Step OQ 29/10/2021 13:40:07



Force Step OQ 29/10/2021 13:46:02


4.6 QC Sample Summary

Mfg. Stage Name UOM Sample for Analysis Validation Sample Additional Sample Other Sample

BLENDING Gram 400 0 0.000 0.000

4.7 Equipment Usage Summary



Version: 1.0.3


Equipment ID Equipment Description Start Date Time End Date Time Usage Time (Hours)

Fixed Equipment

TAC/BIN/179 Tablet Block - Column Mounted conta Blender

28/10/2021 15:55:06 29/10/2021 15:16:27 23

4.8 Yield Summary

Formula: % of Yield = ((Weight of Output Material + In-Process Check Sample + Validation Samples) * 100) / Theoretical Input of Material Weight

Stage Name Theoretical weight (kg)

Weight of output material (kg)

QC Sample Weight (kg)

IP Sample Quantity (kg)

Process Loss (kg)

Rejected Quantity (kg)

Yield % Yield Low Limit %

Yield High Limit %

Complies / Does not comply

BLENDING 187.500 186.480

0.4 0.00 0.620 NA 99.67 98.0 100.0 Comply



Version: 1.0.3


5 Procedure: Compression

SOP Number: Refer SOP/ WI No: F1/PT/001 and eBMR Execution Manual No: SSL/UM/EEB/eBMR

5.1 Unit Procedure:





CON/070 4

CON/024 4

CON/025 4

CON/026 4

CON/027 4

CON/028 4

CON/029 4

CON/030 4






Comments


Scan & verify container [ 1.1.5.14.5.23 ] Active Step Change Incorrect option selected. 31/10/2021 17:16:28




Version: 1.0.3






CON/070 4

CON/071 4

CON/072 4

CON/073 4

CON/074 4

CON/075 4

CON/076 4

CON/077 4

CON/078 4

CON/079 4








Version: 1.0.3


Comments






















5.2 Unit Procedure: Material transfer

5.2.1 Operation:

5.2.1.1 Material Transfer

Scanned IPC/Container for Unloading:IPC/101 Select from the following options:



Version: 1.0.3


1. Scan the product container. ( Do You want to load one more Material container to Destination container ) 2.Weigh the unloaded container ( If required) 3.EXIT ( Selection of Next IPC)

Selection Exit

5.2.1.2 Material Transfer

IPC/Container Barcode Loaded containers

IPC/101 CON/030, CON/029, CON/028

Select from the following options: 1. Scan Empty container 2. Exit ( After completion of activity)

Selection Exit

30/10/2021 11:31:27 31/10/2021 13:33:51 - Sanjeevannara Manikantha teamleasesanjeevm


Comments


Scan the barcode of container with granules to be Splitted [ 1.1.5.11.1.10 ]

Active Step Change OQ 30/10/2021 17:10:56


5.3 Unit Procedure: ECM assembly

5.3.1 Operation: ECM Assembly

5.3.1.1 Scan the Punch/Dies set

Scan the barcode affixed on Die-Punch box containing Punches and Dies set issued for compression.

Tool Type D

Compression Machine ID TAC/COM/227

Identification No. 10.80/7.0

5.3.1.2 Set the ECM with Upper & Lower Punches & Dies

Set the ECM/TURRET with the following punches and corresponding dies.



Version: 1.0.3


Upper Punches 10.8 mm × 7.0 mm oval shaped punches, embossed with a bisect.

Lower Punches 10.8 mm × 7.0 mm oval shaped punches, embossed with “H 10".

Scanned ECM/TURRET : TAC/COM/227B Click the Hyperlink below to launch Equipment Assembling checklist. Assemble the equipment parts as mentioned in checklist. Click Execute Icon when the Assembling activity will be completed. Assembling Checklist Signatures required: OPERATOR




5.4 Unit Procedure: Empty container verification








5.5 Unit Procedure: Line Clearance and Compression activities

5.5.1 Operation: Compression machine assembly

5.5.1.1 Fix the ECM & accessories of Compression machine

Fix the ECM and accessories of Compression machine. Compression Machine ID:TAC/COM/227 ECM ID:TAC/COM/227B



Version: 1.0.3


5.5.1.2 Enter type of Feeder Paddle used.

Select type of feeder paddle used. Signatures required: OPERATOR

Selection Standard




5.5.2 Operation: Compression area line clearance



Identification No. COMPRESSION-5







Previous Product Name HYDROCORTISONE TABLETS USP 5mg





Differential Pressure with respect to 0.3 mmWc 1 3 1.3 Complies




Version: 1.0.3





Comments




5.5.3 Operation: Equipment line clearance from production


Area: COMPRESSION-5 Production Line Clearance for all equipments is completed. Fixed Equipment:


Fixed Equipment ID




COMPRESSION M/C

TAC/COM/227 Double Rotary Fette Compression Machine

Satisfactory


200291910

Movable Equipment:







MTD AND DEDUSTER

TAC/MTD/205 Tablet Block-Metal Detector and De-duster

Satisfactory

2002246 Potassium Chlor ER Tab USP 10mEq [750mg]

200224600

MTD AND DEDUSTER


Satisfactory


200224600







Version: 1.0.3


Comments











Previous Product Name HYDROCORTISONE TABLETS USP 5mg






COMPRESSION-5 Complies

Fixed Equipment:


Fixed Equipment ID




COMPRESSION M/C


Satisfactory


200291910

Movable Equipment:









Version: 1.0.3


MTD AND DEDUSTER


Satisfactory


200224600

MTD AND DEDUSTER


Satisfactory


200224600





Comments




5.5.5 Operation: Challenge test for metal detector

5.5.5.1 Challenge test

Metal Detector: TAC/MTD/204 Use the following standards and perform the challenge test in presence of QA :

Fe (mm) Brass/Non-Fe (mm) SS (mm)

0.3 0.35 0.5

SOP Reference : Refer SOP/WI No: WI/PDN/T080F and eBMR Execution Manual No: UM-03EBMR-001 Select Option "Yes" if challenge test is successful. Click Execute Icon to confirm and continue the activity. Else select Option "No" and click Execute Icon to continue the activity. Signatures required: OPERATOR and QA

User decision YES

Start Date & Time 31/10/2021 07:59:15 End Date & Time 31/10/2021 08:01:01 Activity completed by Operator - teamleasesanjeevm (Sanjeevannara Manikantha) , QA - qam (Test QA manager)


Metal Detector: TAC/MTD/205 Use the following standards and perform the challenge test in presence of QA :



Version: 1.0.3



0.3 0.35 0.5

SOP Reference : Refer SOP/WI No: WI/PDN/T080F and eBMR Execution Manual No: UM-03EBMR-001 Select Option "Yes" if challenge test is successful. Click Execute Icon to confirm and continue the activity. Else select Option "No" and click Execute Icon to continue the activity. Signatures required: OPERATOR and QA

User decision YES

Start Date & Time 31/10/2021 08:02:40 End Date & Time 31/10/2021 08:03:19 Activity completed by Operator - teamleasesanjeevm (Sanjeevannara Manikantha) , QA - qam (Test QA manager)

31/10/2021 07:55:08 31/10/2021 08:03:19 Operator - Sanjeevannara Manikantha, QA -

Test QA manager teamleasesanjeevm, qam


5.5.6 Operation: Compression machine parameter set-up


Set the Recipe name/ parameters in PLC to compress the specified product. Click Execute Icon to verify that PLC parameters are set correctly. Recipe Name: HYDROCORTISONE TABLETS 10 Mg


Tablets Per Hour x 1000 A - (Limit: 35.28 to 211.68) TPH

Tablets Per Hour x 1000 B - (Limit: 35.28 to 211.68) TPH

Rotor Speed - (Limit: 06 to 36) RPM

Prescompression Force station 01 - (Limit: 0.1 to 3.0) kN


Mainscompression Force station 1 - (Limit: 2.5 to 5.0) kN


Precompression pen station 1 5 (Limit: 1 to 5) mm


Maincompression pen station 1 5 (Limit: 1 to 5) mm





Version: 1.0.3





5.5.7 Operation: Compression machine setting

5.5.7.1 Sample Collection & Completion of machine setting activities

Start compression. Discard the tablets produced for initial two rounds. Take sample of more than one round of tablets & check all applicable parameters as per below table.

Test Name Test Code

Test Instrument

UOM Target Alert Limit Low

Alert Limit High

Action Limit Low

Action Limit High

Test Conditions

Individual Weight

TC-001

Analytical Weighing Balance

g NA NA NA NA NA NA

Average Weight

TC-002

NA g 0.250000 NA NA 0.242500 0.257500 NA

Group Weight TC-003


g 5.0000 NA NA 4.8500 5.1500 NA

Weight of Tablets before Friability Test

TC-014


g NA NA NA NA NA Specific Instructions

Number of Rotations for Friability Test = 100

NA

Weight of Tablets after Friability Test

TC-015


g NA NA NA NA NA Specific Instructions

Number of Rotations for Friability Test = 100

NA

Thickness TC-027

Measuring Equipment

mm 4.00 3.50 4.50 3.00 5.00 NA

Hardness TC-029

Hardness Testers

kp 6.00 5.00 7.00 4.00 8.00 NA

Friability TC-030

NA %w/w 1.0000 NA NA NA 1.0000

Number Of Rotation

100 NA

Specific Instructions

Number of Rotations for

NA



Version: 1.0.3


Friability Test = 100

Disintegration Time

TC-031

DT Apparatuses

Min NA NA NA NA 15 Temperature_Max 37.0(35.0 to 39.0) °C

Temperature_Min 37.0(35.0 to 39.0) °C

Uniformity of Weight- Maximum in mg

TC-048

NA mg 250.000 240.000 260.000 237.500 262.500 NA

Uniformity of Weight- Minimum in mg

TC-049

NA mg 250.000 240.000 260.000 237.500 262.500 Specific Instructions

NMT 2 of the individual masses deviate from the average mass by more than ± 5% and none deviate by more than ± 10%

NA

Dimensions- Length

TC-050

Measuring Equipment

mm 10.80 NA NA 10.60 11.00 NA

Dimensions- Width

TC-051

Measuring Equipment

mm 7.00 NA NA 6.80 7.20 NA

Machine Parameter Settings:


Tablets Per Hour x 1000 A - (Limit: 35.28 to 211.68) TPH

Tablets Per Hour x 1000 B - (Limit: 35.28 to 211.68) TPH

Rotor Speed - (Limit: 06 to 36) RPM









In the following field provide the sample quanity collected in grams for testing. Click Execute Icon to confirm machine setting completion. Signatures required: OPERATOR and SUPERVISOR



Version: 1.0.3


User entry 100

Start Date & Time 31/10/2021 08:24:21 End Date & Time 31/10/2021 08:26:49 Activity completed by Operator - teamleasesanjeevm (Sanjeevannara Manikantha) , Supervisor - qam (Test QA manager)

5.5.7.2 Machine Setting Rejects

Machine Setting Rejection weighing details:

Material Code

Container/Polybag Barcode

Scale Low Range

Scale High Range

Actual Weight

UOM Compression Machine Chute

Verification Status

WIP -I8F80D4DA7056$ 0.2 150.0 1 kg Left Side Complies

5.5.7.3 Machine Setting Rejects

Machine Setting Rejection weighing details:

Material Code

Container/Polybag Barcode

Scale Low Range

Scale High Range

Actual Weight

UOM Compression Machine Chute

Verification Status

WIP -IBD3814C95335$ 0.2 150.0 1 kg Right Side Complies

31/10/2021 08:22:50 31/10/2021 08:33:24 QA - Test QA manager, Operator - Sanjeevannara




Comments


Keep the tablets produced during setting on balance [ 1.1.5.10.21.23 ]

Force Step OQ 31/10/2021 08:30:47


Keep the tablets produced during setting on balance [ 1.1.5.10.21.23 ]

Force Step OQ 31/10/2021 08:32:33


5.5.8 Operation:

5.5.8.1

Enter the PKB system spray rate for Fette compression machine Note : For Fette compression machine PKB system spray rate shall be Record.



Version: 1.0.3


User Entry 10



5.5.9 Operation: Compression start up test

5.5.9.1 Production Start up completed

Production Start-up samples comply with the specifications. Inform QA to collect Samples and perform Start-up Test. Click Execute Icon to confirm the communication and to continue the activity. Signatures required: SUPERVISOR


5.5.9.2 Start up samples OK. QA clearance to start production

Start-up samples comply with the specifications. QA to give clearance to start the production. Signatures required: QA




Linked Workflows

Linked Workflow Number Start Date End Date

200664830-LINK-1 (OP_IP_SAMPLE_COLLECTION_2) [ 1.1.5.10.23.4 ]

31/10/2021 08:41:06 31/10/2021 08:45:12


31/10/2021 09:46:56 31/10/2021 09:50:16

5.5.10 Operation:

5.5.10.1 Message for confirmation

Select option 'Yes' to Enter the PKB spray rate at every 2hrs for Fette compression machine Else select 'No' Exit the workflow.



Version: 1.0.3


User decision NO



5.5.11 Operation: Compression

5.5.11.1 Compression

Start the compression machine. Collect the required samples. Note: Open parallel workflow to collect required In-Process samples. Select an option and execute the step: 1.Scan empty container to print label 2.Scan container to unload tablets 3.Load blend container 4.Scan loaded empty container 5.Weigh tablet container 6.Exit (after completion of Compression) Refer to the Below Table for Loading the Lubricated Granules for Compression.


WIP Lubricated Granules NA 20 2

Selection Exit

5.5.11.2 Compressed Tablets


1 Compressed Tablets CON/071 kg 21 NA 26.140 28.140 2.000









Version: 1.0.3




Recipe Comments


Compression Edit Parameters OQ 31/10/2021 12:22:56


Comments


Keep the tablets filled container on balance [ 1.1.5.10.31.46 ] Force Step OQ 31/10/2021 12:17:53
















Scan the empty container with double polybags [ 1.1.5.10.31.5 ]

Active Step Change Incorrect option selected 31/10/2021 13:29:16




Version: 1.0.3


5.5.12 Operation: Compression & in-process sampling core

5.5.12.1 In-process sampling, Sample collection

Start the compression machine and collect the required samples. Select an option and execute the step: 1. Collect60minute sample 2. Collect120minute sample 3. Machine re-setting 4. Actual parameters 5. Refresh 6. Exit Click the hyperlink below to open IPQA Test portal & perform the tests. IPQA Test Portal

5.5.12.2 Actual Parameters







Equipment Code

TAC/COM/227

Data Capture Interval in min

30

Parameter Rotor Speed (RPM)

Pre Comp Force station 1 (kN)

Pre comp Force station 2 (kN)

Main comp Force station 1 (kN)

Main comp Force station 2 (kN)

Pre comp penetration stn 1 (mm)

Pre comp penetration stn 2 (mm)

Main comp penetration stn 1 (mm)

Main comp penetration stn 2 (mm)

Machine Status (1-Running 0-Stopped) (NA)

Time Stamp



Version: 1.0.3


31/10/2021 15:09:16

17 0.00 0.00 0.00 0.00 0 0 0 0 1

31/10/2021 15:09:42

17 0.00 0.00 0.00 0.00 0 0 0 0 1



Linked Workflows

Linked Workflow Number Start Date End Date


31/10/2021 11:25:56 31/10/2021 11:28:30

5.5.13 Operation: Metal detector challenge test


Metal Detector: TAC/MTD/204 Use the following standards and perform the challenge test :


0.3 0.35 0.5

SOP Reference : Refer SOP/WI No: WI/PDN/T080F and eBMR Execution Manual No: UM-03EBMR-001 Select Option "Yes" if challenge test is successful. Click Execute Icon to confirm and continue the activity. Else select Option "No" and click Execute Icon to continue the activity. Signatures required: OPERATOR and SUPERVISOR

User decision YES



Metal Detector: TAC/MTD/205 Use the following standards and perform the challenge test :


0.3 0.35 0.5



Version: 1.0.3


SOP Reference : Refer SOP/WI No: WI/PDN/T080F and eBMR Execution Manual No: UM-03EBMR-001 Select Option "Yes" if challenge test is successful. Click Execute Icon to confirm and continue the activity. Else select Option "No" and click Execute Icon to continue the activity. Signatures required: OPERATOR and SUPERVISOR

User decision YES


31/10/2021 15:11:21 31/10/2021 15:23:14 Operator - Sanjeevannara Manikantha,

Supervisor - Test QA manager teamleasesanjeevm, qam


5.5.14 Operation: Metal detection for rejected product

5.5.14.1 Rejection observed?

Pass the rejected tablets through the metal detector. Metal Detector ID: TAC/MTD/204 Rejection Observed? Select Option "Yes", if rejection is observed. Click Execute Icon to confirm and continue the activity. Else select Option "No" and click Execute Icon to confirm and continue the activity. Signatures required: SUPERVISOR

User decision NO



Pass the rejected tablets through the metal detector. Metal Detector ID: TAC/MTD/205 Rejection Observed? Select Option "Yes", if rejection is observed. Click Execute Icon to confirm and continue the activity. Else select Option "No" and click Execute Icon to confirm and continue the activity. Signatures required: SUPERVISOR

User decision NO




Version: 1.0.3




5.5.15 Operation: Compression rejection

5.5.15.1 Scan the barcode of the rejection container

Scan the barcode of the rejection container for collecting rejected tablets.

Identification No. TAC/REJ/001




5.5.15.3 Destroy final run rejects

Destroy the rejected product as per SOP. SOP Reference : Refer SOP/WI No: GQA/046 and eBMR Execution Manual No: UM-03EBMR-001

Rejection Container Barcode Material Description Weighed Quantity UOM

TAC/REJ/001 Rejected Tablets -1.500 kg













Version: 1.0.3















TAC/REJ/014 Rejected Tablets 0.400 kg







Select "Yes" if rejection is observed during compression or "No" to continue the activity. Signatures required: SUPERVISOR

User decision YES




Version: 1.0.3


5.5.15.11 Scan scale for weighing the rejected tablets

Scan the Barcode affixed on weighing scale for weighing the rejected tablets.





TAC/REJ/018 Rejected Tablets 3.400 kg





Comments


Keep the rejected tablets on balance [ 1.1.5.10.37.15 ] Force Step OQ 31/10/2021 12:41:20




Error message [ 1.1.5.10.37.24 ] Active Step Change OQ 31/10/2021 12:55:08










Version: 1.0.3


5.6 In-Process Sample Collection Summary

Manufacturing Operation

Lot Number

Stage ID Sample ID Sample Quantity (in Grams)

Sample Collection Point

Sample Collected Time

COMPRESSION NA TAB_STAGE16 (Startup- Prod) 5353 67.000 LEFT SIDE 31/10/2021 08:43:54

COMPRESSION NA TAB_STAGE16 (Startup- Prod) 5354 67.000 RIGHT SIDE 31/10/2021 08:45:02

COMPRESSION NA TAB_STAGE17 (Startup- QA) 5355 67.000 LEFT SIDE 31/10/2021 09:49:12

COMPRESSION NA TAB_STAGE17 (Startup- QA) 5356 67.000 RIGHT SIDE 31/10/2021 09:50:05

COMPRESSION NA TAB_STAGE14 (30/60 min InProcess check)

5357 15.000 LEFT SIDE 31/10/2021 11:27:31

COMPRESSION NA TAB_STAGE14 (30/60 min InProcess check)

5358 15.000 RIGHT SIDE 31/10/2021 11:28:20

COMPRESSION NA TAB_STAGE15 (QA\Production Executive)

5359 25.000 LEFT SIDE 31/10/2021 11:44:27

COMPRESSION NA TAB_STAGE15 (QA\Production Executive)

5360 25.000 RIGHT SIDE 31/10/2021 11:45:42

5.7 In-Process Test Result Summary

Lot Number

Test Name Sample Collection Point Alert Limit Action Limit Maximum Actual Value

Minimum Actual Value

UOM

NA Group Weight (Stage: 30/60 min InProcess check)

LEFT SIDE NA NLT 4.850 NMT 5.150

5.0000 5.0000 g

NA Individual Weight (Stage: QA\Production Executive)

LEFT SIDE NA NA 0.250000 0.250000 g

NA Average Weight (Stage: QA\Production Executive)

LEFT SIDE NA NLT .24250 NMT .25750

0.250000 0.250000 g

NA Uniformity of Weight- Maximum in mg (Stage: QA\Production Executive)

LEFT SIDE NLT 240.000 NMT 260.000

NLT 237.500 NMT 262.500

250.000 250.000 mg

NA Uniformity of Weight- Minimum in mg (Stage: QA\Production Executive)


NLT 237.500 NMT 262.500

250.000 250.000 mg

NA Individual Weight (Stage: Startup- Prod)

LEFT SIDE NA NA 0.250000 0.25000 g

NA Average Weight (Stage: Startup- Prod)


0.250000 0.250000 g

NA Individual Weight (Stage: Startup- QA)

LEFT SIDE NA NA 0.250000 0.250000 g

NA Average Weight (Stage: Startup- QA)


0.250000 0.250000 g



Version: 1.0.3


NA Uniformity of Weight- Maximum in mg (Stage: Startup- QA)


NLT 237.500 NMT 262.500

250.000 250.000 mg

NA Uniformity of Weight- Minimum in mg (Stage: Startup- QA)


NLT 237.500 NMT 262.500

250.000 250.000 mg

NA Group Weight (Stage: 30/60 min InProcess check)

RIGHT SIDE NA NLT 4.850 NMT 5.150

5.0000 5.0000 g

NA Individual Weight (Stage: QA\Production Executive)

RIGHT SIDE NA NA 0.250000 0.250000 g

NA Average Weight (Stage: QA\Production Executive)

RIGHT SIDE NA NLT .24250 NMT .25750

0.250000 0.250000 g

NA Uniformity of Weight- Maximum in mg (Stage: QA\Production Executive)

RIGHT SIDE NLT 240.000 NMT 260.000

NLT 237.500 NMT 262.500

250.000 250.000 mg

NA Uniformity of Weight- Minimum in mg (Stage: QA\Production Executive)


NLT 237.500 NMT 262.500

250.000 250.000 mg

NA Individual Weight (Stage: Startup- Prod)

RIGHT SIDE NA NA 0.250000 0.250000 g

NA Average Weight (Stage: Startup- Prod)


0.250000 0.250000 g

NA Individual Weight (Stage: Startup- QA)

RIGHT SIDE NA NA 0.250000 0.250000 g

NA Average Weight (Stage: Startup- QA)


0.250000 0.250000 g

NA Uniformity of Weight- Maximum in mg (Stage: Startup- QA)


NLT 237.500 NMT 262.500

250.000 250.000 mg

NA Uniformity of Weight- Minimum in mg (Stage: Startup- QA)


NLT 237.500 NMT 262.500

250.000 250.000 mg

5.8 QC Sample Summary

Mfg. Stage Name UOM Sample for Analysis Validation Sample Additional Sample Other Sample

COMPRESSION Gram 300 0 0.000 0.000

5.9 Equipment Usage Summary

Equipment ID Equipment Description Start Date Time End Date Time Usage Time (Hours)

Fixed Equipment


31/10/2021 08:04:49 02/11/2021 09:55:27 49



Version: 1.0.3


5.10 Yield Summary






Process Loss (kg)



Yield High Limit %


COMPRESSION 187.500 182.980

0.3 2.448 0.752 3.4 99.05 95.0 100.0 Comply



Version: 1.0.3


6 Procedure: Inspection Procedure-1

SOP Number: Refer SOP/WI No: F1/PT/002 and eBMR Execution Manual No: SSL/UM/EEB/eBMR

6.1 Unit Procedure:

6.1.1 Operation:

6.1.1.1 Message for confirmation

Select option 'Yes' to SIlicagel sachetes addition and removal is applicable. Else select option 'No' to if not applicable. Signatures required: SUPERVISOR

User decision YES








CON/024 4

CON/025 4

CON/026 4

CON/027 4

CON/028 4

CON/029 4

CON/030 4




Version: 1.0.3



02/11/2021 11:47:26 02/11/2021 16:25:18 Supervisor - Sanjeevannara Manikantha, QA - Test QA

manager teamleasesanjeevm, qam


Comments




















CON/077 4

CON/078 4

CON/076 4



Version: 1.0.3


CON/075 4

CON/072 4

CON/071 4

CON/079 4

CON/070 4

CON/073 4

CON/074 4



02/11/2021 11:47:37 02/11/2021 13:55:49 Supervisor - Sanjeevannara Manikantha,

QA - Test QA manager teamleasesanjeevm, qam


6.2 Unit Procedure: Line clearance for inspection

6.2.1 Operation: Production area line clearance



Identification No. INSPECTION-2







Version: 1.0.3


Previous Process Order Number NONE


Previous Product Name Nizatidine Cap 300 mg-HGC





Differential Pressure with respect to Corridor mmWc 0 5 1.4 Complies





Comments




6.2.2 Operation: Production equipment line clearance


Area: INSPECTION-2 Production Line Clearance for all equipments is completed. Fixed Equipment:


Fixed Equipment ID



Previous Product Name

Previous Process Order Number

AIM TAC/AIN/234 Tablet Block - Auto inspection Machine

Satisfactory

NONE NONE NONE

Movable Equipment:









Version: 1.0.3


SS TRAY TAC/SR-01 Tablet Block-SS Tray

Satisfactory

2006648 HYDROCORTISONE TABLETS USP 10mg

200664804


Satisfactory

2002997 Lami Nevi & ZIdo tab-30/50/60mg-OS-PEPFA

200299704





Comments









Previous Process Order NONE


Previous Product Name Nizatidine Cap 300 mg-HGC







Version: 1.0.3



INSPECTION-2 Complies

Fixed Equipment:


Fixed Equipment ID



Previous Product Name

Previous Process Order Number

AIM TAC/AIN/234 Tablet Block - Auto inspection Machine

Satisfactory

NONE NONE NONE

Movable Equipment:








Satisfactory

2006648 HYDROCORTISONE TABLETS USP 10mg

200664804


Satisfactory

2002997 Lami Nevi & ZIdo tab-30/50/60mg-OS-PEPFA

200299704





Comments




6.3 Unit Procedure: Container verification







Version: 1.0.3





6.4 Unit Procedure: Inspection

6.4.1 Operation: Inspection operation

6.4.1.1 Scan Scale for weighing the Product

Scan the barcode affixed to the weighing scale for weighing the inspected product container.


6.4.1.2 Scan Scale for Weighing defective product

Scan the barcode affixed to the weighing scale for weighing the rejected product.


6.4.1.3 Container weighing details

Container weighing details:

Material Code Material Description Material Barcode UOM Scale Low Range Scale High Range Actual Value Verification Status

WIP Defective product -I0D3343877056$ kg 0.2 150.0 0.200 Complies

6.4.1.4 Inspection

Select from the following options: 1. Scan Empty container (To print label and collect inspected product). 2. Print Inspection Rejects Labels 3. Scan the product container. 4. Scan Inspected Empty Container (After completion of inspection). 5.Exit. List of SS Trays for Performing Inspection: TAC/SR-01, TAC/SR-02

Selection Exit

6.4.1.5 Inspection

Select from the following options: 1. Weigh the product container 2. Weigh Inspection Rejects Quantity. 3. Inspection Complete (Exit).



Version: 1.0.3


Selection Inspection Complete (Exit)

6.4.1.6 Inspected containers


1 Inspection CON/024 kg 22 NA 26.110 28.110 2.000







6.4.1.7 Destroy the process rejects as per SOP

Lot Number Total weight of Inspected product in kg Total weight of good product in kg Total weight of rejected product in kg Loss of Inspection in %

NA 182.98 182.770 0.20 0.11

% Destroy the rejects as per SOP. Click Execute Icon to confirm this activity and to continue the activity. SOP Reference: GQA/046 and eBMR Execution Manual No: UM-03EBMR-001 Signatures required: OPERATOR






Version: 1.0.3


Recipe Comments


Inspection operation Edit Parameters OQ 02/11/2021 15:26:02


Comments


Read the container weight from balance [ 1.1.7.11.2.71 ] Force Step OQ 02/11/2021 15:19:27


















Keep the defected product on scale [ 1.1.7.11.2.79 ] Force Step OQ 02/11/2021 15:55:34




Version: 1.0.3


6.5 Unit Procedure: AQL

6.5.1 Operation: Acceptable Quality Level Check

6.5.1.1 Container range entry for AQL

Enter the first container number and last container number to perform AQL for all containers between first and last container

Enter first Container Number 1

Enter last Container Number 7

6.5.1.2 AQL Passed

Defect Name Quantity(Nos.) DefectType

Different Product 0 Critical

Tablets with adhering/Embedded Foreign/Extraneous particles. 0 Critical

Tablets with stains 0 Critical

Broken Tablets 0 Critical

Capped Tablets 0 Critical

Soft Tablets 0 Critical

Over size/ under size tablets 0 Critical

Missing imprints/engraving 0 Critical

Black Specs/Oil Spots 0 Critical

Others 0 Critical

Cracks on coated tablets 0 Major

Tablets with peeling 0 Major

Tablets with rough surface 0 Major

Tablets with Illegible Engraving 0 Major

Mottled Tablets 0 Major

Black Spot(TUPP) 0 Major

Twins / Triplets 0 Major

Tablets with Shade Variation 0 Major

Incompeletly Coated tablets 0 Major

Illegible Printing/Partial Text Mixing in Printed Tablets 0 Major

Collared tablets 0 Major

Others 0 Major

Edge Eroded Tablets 0 Minor

Printing Defects 0 Minor

Sticking 0 Minor

Chipping 0 Minor



Version: 1.0.3


Picking 0 Minor

Others 0 Minor

Defect Type Acceptable Limit of Defects (%) Actual Defects (%)

Critical Defects 0 0.000

Major Defects 0.5 0.000

Minor Defects 2 0.000

AQL Passed. Product is ready for next stage (Packaging ).

6.5.1.3 Destroy rejects.

Inspected product to be redistributed equally in all containers. Destroy all the product with defects found in AQL. SOP Reference : Refer SOP/WI No: GQA/046 and eBMR Execution Manual No: UM-03EBMR-001 Signatures required: SUPERVISOR and QA

Start Date & Time 02/11/2021 16:18:45 End Date & Time 02/11/2021 16:26:40 Activity completed by Supervisor - qam (Test QA manager) , QA - teamleasesanjeevm (Sanjeevannara Manikantha)

6.5.1.4 Read average of average wt of tablet



6.6 Yield Summary






Process Loss (kg)



Yield High Limit %


INSPECTION 187.500 182.770 [Numbers: 731080]

0.00 0.00 0.210 0.20 97.48 92.0 100.0 Comply



Version: 1.0.3


7 Deviation and Notification Summary

Notification Details

No. Area Equipment Priority Notification Type Notification Info Workflow Status Deviation No.

Acknowledged By

Closed By Received On

8 Yield Summary






Process Loss (kg)



Yield High Limit %


BLENDING 187.500 186.480

0.4 0.00 0.620 NA 99.67 98.0 100.0 Comply

COMPRESSION 187.500 182.980

0.3 2.448 0.752 3.4 99.05 95.0 100.0 Comply

INSPECTION 187.500 182.770 [Numbers: 731080]

0.00 0.00 0.210 0.20 97.48 92.0 100.0 Comply

9 Label Summary

Manufacturing Operation Label Type Count

Blending

MATERIAL_STATUS 23

REJECT_MATERIAL 1

QC_SAMPLE 1

Inspection MATERIAL_STATUS 14

REJECT_MATERIAL 2

Compression

MATERIAL_STATUS 10

REJECT_MATERIAL 10

IN_PROCESS_SAMPLE 8

QC_SAMPLE 1

Documents

Batch Manufacturing Report