Recipe Header

Recipe Header
Plant Code Recipe Name Recipe Version Recipe State
2000 TEST CROM 1 Released

Product Product Name Valid From Valid To

3000173 Toluene 04/27/2020 15:37 10/31/+292275056 09:57

Base Qty UoM From Lot Size To Lot Size

100.0 N/A 10.0 100.0

Recipe Group Product Version Recipe Status Effective Date

N/A N/A Created

Process Order Batch Number Manufacturing Date Expiry Date

Resource Details - List of critical resources permitted to use in production

Resource ID Resource Name Alternate Resource ID Alternate Resource Name
10000931 CCA-001
10000926 G2CEX-01

Material Requirement - BOM

Phase Material Material Desc Material Code Storage Loc Planned Qty UoM
Name Type
0080 Raw-Material Media Product 000000000800000234 0010 950.0 L

Electronic Log Books At Resource Level

Resource ID ELog Book ID ELog Name Start Phase End Phase
10000931
10000926

Phase Manufacturing Instructions

Resource Name Operation Name Phase Number Phase Display Name
CCA-001 0010 (List of References) 0020 List of References and
Precaution

Manufacturing Instructions
Parameter Name Parameter Value
RP_GenericDescription N/A
RP_CanExecProfile Operator,Supervisor
RP_InstBold1 N/A
RP_Instruction1 Reference Documents
Access reference documents like SOPs, EOPs and ECCs during
execution through shared link whenever required.
RP_SpecialHandling1 N/A
RP_InstBold2 N/A
RP_Instruction2 Safety Precaution:-
Wear gloves, goggle, masks and apron while handling alkali, fine
powders or acids. Refer respective MSDS before handling the

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Manufacturing Instructions
Parameter Name Parameter Value
respective material through shared link.
RP_SpecialHandling2 N/A
RP_InstBold3 N/A
RP_Instruction3 N/A
RP_SpecialHandling3 N/A
RP_InstBold4 N/A
RP_Instruction4 N/A
RP_SpecialHandling4 N/A
RP_InstBold5 N/A
RP_Instruction5 N/A
RP_SpecialHandling5 N/A
RP_InstBold6 N/A
RP_Instruction6 N/A
RP_SpecialHandling6 N/A
RP_SharedLink1 N/A
RP_SharedLink2 N/A
RP_SharedLink3 N/A
RP_DocLinkCaption1 MSDS
RP_DocLinkURL1 MSDS.pdf
RP_DocLinkCaption2 N/A
RP_DocLinkURL2 N/A
RP_DocLinkCaption3 N/A
RP_DocLinkURL3 N/A
RP_PerformedBy true
RP_CheckedBy N/A
RP_CheckedByCaption Checked By
RP_ECheckerProfile None
RP_VerifiedBy N/A
RP_VerifiedByCaption Verified By
RP_ESignProfile None

Phase Manufacturing Instructions

Resource Name Operation Name Phase Number Phase Display Name
CCA-001 0030 (Production Fermentation) 0040 Area Ceritfication

Manufacturing Instructions
Parameter Name Parameter Value
RP_GenericDescription N/A
RP_CanExecProfile Supervisor,Operator
RP_InstBold1 N/A

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Manufacturing Instructions
Parameter Name Parameter Value
RP_Instruction1 Verification of cleanliness for equipments and area certification.
RP_SpecialHandling1 N/A
RP_InstBold2 N/A
RP_Instruction2 N/A
RP_SpecialHandling2 N/A
RP_InstBold3 N/A
RP_Instruction3 N/A
RP_SpecialHandling3 N/A
RP_DocLinkCaption1 N/A
RP_DocLinkURL1 N/A
RP_DocLinkCaption2 N/A
RP_DocLinkURL2 N/A
RP_DocLinkCaption3 N/A
RP_DocLinkURL3 N/A
RP_ComplainceAtEachCheck N/A
RP_ValidateBatchCount true
RP_AllowedBatchCount 5
RP_IsScaleCalibratedorVerified true
RP_IsScaleCleanedNotRequired true
RP_ClearanceFor Production
RP_AllowInAcquiredState N/A
RP_ComplianceOptionList N/A
RP_NegativeOptionList N/A
RP_CheckpointDetails N/A
RP_Checkpoint1 Check visual cleanliness of chromatography equipment.
RP_InstructionImage1 N/A
RP_SpecialNote1 N/A
RP_Checkpoint2 Check visual cleanliness of area.
RP_InstructionImage2 N/A
RP_SpecialNote2 N/A
RP_Checkpoint3 Check PM & Calibration Dates for equipment
RP_InstructionImage3 N/A
RP_SpecialNote3 N/A
RP_Checkpoint4 N/A
RP_InstructionImage4 N/A
RP_SpecialNote4 N/A
RP_Checkpoint5 N/A
RP_InstructionImage5 N/A
RP_SpecialNote5 N/A

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Manufacturing Instructions
Parameter Name Parameter Value
RP_Checkpoint6 N/A
RP_InstructionImage6 N/A
RP_SpecialNote6 N/A
RP_Checkpoint7 N/A
RP_InstructionImage7 N/A
RP_SpecialNote7 N/A
RP_Checkpoint8 N/A
RP_InstructionImage8 N/A
RP_SpecialNote8 N/A
RP_Checkpoint9 N/A
RP_InstructionImage9 N/A
RP_SpecialNote9 N/A
RP_Checkpoint10 N/A
RP_InstructionImage10 N/A
RP_SpecialNote10 N/A
RP_Checkpoint11 N/A
RP_InstructionImage11 N/A
RP_SpecialNote11 N/A
RP_Checkpoint12 N/A
RP_InstructionImage12 N/A
RP_SpecialNote12 N/A
RP_Checkpoint13 N/A
RP_InstructionImage13 N/A
RP_SpecialNote13 N/A
RP_Checkpoint14 N/A
RP_InstructionImage14 N/A
RP_SpecialNote14 N/A
RP_Checkpoint15 N/A
RP_InstructionImage15 N/A
RP_SpecialNote15 N/A
RP_Checkpoint16 N/A
RP_InstructionImage16 N/A
RP_SpecialNote16 N/A
RP_Checkpoint17 N/A
RP_InstructionImage17 N/A
RP_SpecialNote17 N/A
RP_Checkpoint18 N/A
RP_InstructionImage18 N/A
RP_SpecialNote18 N/A

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 Recipe Header

Manufacturing Instructions
Parameter Name Parameter Value
RP_Checkpoint19 N/A
RP_InstructionImage19 N/A
RP_SpecialNote19 N/A
RP_Checkpoint20 N/A
RP_InstructionImage20 N/A
RP_SpecialNote20 N/A
RP_LabelPrintRequired N/A
RP_PhaseNumberInCaseofRejected N/A
RP_PositiveFinalCompliance N/A
RP_NegativeFinalCompliance N/A
RP_EquipmentStatusToDisplay true
RP_ResourceClasses ResourceClass,SecondaryEquipmentClass
RP_IndividualResourceLC N/A
RP_CheckedByLC N/A
RP_ECheckerProfileLC None
RP_CheckedByFailedLCAuth N/A
RP_ECheckerProfileFailedLCAuth None
RP_VerifiedByForException N/A
RP_ESignProfileForException None
RP_PerformedBy true
RP_CheckedBy true
RP_CheckedByCaption Checked By
RP_ECheckerProfile QA
RP_VerifiedBy N/A
RP_VerifiedByCaption Verified By
RP_ESignProfile None
Comment1 N/A
Comment2 N/A
Comment3 N/A
Comment4 N/A
Comment5 N/A
Comment6 N/A
Comment7 N/A
Comment8 N/A
Comment9 N/A
Comment10 N/A
Comment11 N/A
Comment12 N/A
Comment13 N/A

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 Recipe Header

Manufacturing Instructions
Parameter Name Parameter Value
Comment14 N/A
Comment15 N/A
Comment16 N/A
Comment17 N/A
Comment18 N/A
Comment19 N/A
Comment20 N/A
Compliance1 N/A
Compliance2 N/A
Compliance3 N/A
Compliance4 N/A
Compliance5 N/A
Compliance6 N/A
Compliance7 N/A
Compliance8 N/A
Compliance9 N/A
Compliance10 N/A
Compliance11 N/A
Compliance12 N/A
Compliance13 N/A
Compliance14 N/A
Compliance15 N/A
Compliance16 N/A
Compliance17 N/A
Compliance18 N/A
Compliance19 N/A
Compliance20 N/A
ClearanceComment N/A
LineClearance N/A

Phase Manufacturing Instructions

Resource Name Operation Name Phase Number Phase Display Name
CCA-001 0050 (Status Update) 0060 In-Process Status Update

Manufacturing Instructions
Parameter Name Parameter Value
RP_GenericDescription N/A
RP_CanExecProfile ALL
RP_InstBold1 N/A
RP_Instruction1 Print "In-Process Status" label and attach to equipment's.

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 Recipe Header

Manufacturing Instructions
Parameter Name Parameter Value
RP_SpecialHandling1 N/A
RP_InstBold2 N/A
RP_Instruction2 N/A
RP_SpecialHandling2 N/A
RP_LabelPrintRequired true
RP_ResourceTypeRoom true
RP_ResourceTypePrimary true
RP_ResourceTypeScale true
RP_StatusUpdateType Product Run
RP_SetState Acquired
RP_CheckClearanceValidity N/A
RP_ExpiryOverrideAuthProfile None
RP_UpdateInfoManually N/A
RP_PerformedBy false
RP_CheckedBy false
RP_CheckedByCaption Checked By
RP_ECheckerProfile None
RP_VerifiedBy N/A
RP_VerifiedByCaption Verified By
RP_ESignProfile None

Phase Manufacturing Instructions

Resource Name Operation Name Phase Number Phase Display Name
G2CEX-01 0070 (Material Charge) 0080 Charge Filtered Product

Manufacturing Instructions
Parameter Name Parameter Value
RP_CanExecProfile Operator
RP_OperationSOPTraining N/A
RP_Instruction1 Charge the filtered product.
RP_SpecialHandling1 N/A
RP_Instruction2 N/A
RP_SpecialHandling2 N/A
RP_Material1 000000000800000234
RP_Limit1 N/A
RP_InProcessStage N/A
RP_PerformedBy true
RP_CheckedBy N/A
RP_CheckedByCaption Checked By
RP_ECheckerProfile None

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 Recipe Header

Manufacturing Instructions
Parameter Name Parameter Value
AccumulatedNetWeight N/A
UoM1 N/A

Phase Manufacturing Instructions

Resource Name Operation Name Phase Number Phase Display Name
G2CEX-01 0090 (A. AWFI Wash_) 0100 Parameter Read

Manufacturing Instructions
Parameter Name Parameter Value
RP_GenericDescription N/A
RP_CanExecProfile Operator
RP_InstBold1 N/A
RP_Instruction1 AWFI Wash parameter read.
RP_SpecialHandling1 N/A
RP_InstBold2 N/A
RP_Instruction2 N/A
RP_SpecialHandling2 During AWFI wash remove the air bubbles by venting the T20” filter.
RP_UseOPCTagAlias true
RP_AutoExecutePeriodically true
RP_PollInterval 60
RP_OPCSubtaskCaption AWFI Wash Parameter Details
RP_DescriptionParam1 Flow Rate
RP_OPCTag1 FlowRate
RP_DescriptionParam2 Pre-Column pH
RP_OPCTag2 PreColumnpH
RP_DescriptionParam3 Pre-Column Cond.
RP_OPCTag3 PreColumnCond
RP_DescriptionParam4 Pre-Column Temp.
RP_OPCTag4 PreColumnTemp
RP_DescriptionParam5 Column Inlet Press.
RP_OPCTag5 ColumnInletPressure
RP_DescriptionParam6 Volume Passed
RP_OPCTag6 VolumePassed
RP_DescriptionParam7 N/A
RP_OPCTag7 N/A
RP_DescriptionParam8 N/A
RP_OPCTag8 N/A
RP_DeviationHandlingType N/A
RP_DeviationEventType All Readings
RP_PerformedBy true

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 Recipe Header

Manufacturing Instructions
Parameter Name Parameter Value
RP_CheckedBy true
RP_ECheckerProfile Supervisor
RP_VerifiedBy N/A
RP_ESignProfile None
ReadParam1 17.44
ReadParam2 N/A
ReadParam3 N/A
ReadParam4 N/A
ReadParam5 N/A
ReadParam6 471
ReadParam7 N/A
ReadParam8 N/A

Phase Manufacturing Instructions

Resource Name Operation Name Phase Number Phase Display Name
G2CEX-01 0110 (B. Equilibration_) 0120 Parameter Read

Manufacturing Instructions
Parameter Name Parameter Value
RP_GenericDescription N/A
RP_CanExecProfile Operator
RP_InstBold1 N/A
RP_Instruction1 Equilibration parameter read.
RP_SpecialHandling1 N/A
RP_InstBold2 N/A
RP_Instruction2 N/A
RP_SpecialHandling2 N/A
RP_UseOPCTagAlias true
RP_AutoExecutePeriodically true
RP_PollInterval 60
RP_OPCSubtaskCaption Equilibration Parameter Details
RP_DescriptionParam1 Flow Rate
RP_OPCTag1 FlowRate
RP_DescriptionParam2 Pre-Column pH
RP_OPCTag2 PreColumnpH
RP_DescriptionParam3 Pre-Column Cond.
RP_OPCTag3 PreColumnCond
RP_DescriptionParam4 Pre-Column Temp.
RP_OPCTag4 PreColumnTemp
RP_DescriptionParam5 Column Inlet Press.

Page 9 of 13
 Recipe Header

Manufacturing Instructions
Parameter Name Parameter Value
RP_OPCTag5 ColumnInletPressure
RP_DescriptionParam6 Volume Passed
RP_OPCTag6 VolumePassed
RP_DescriptionParam7 Post-Column pH
RP_OPCTag7 PostColumnpH
RP_DescriptionParam8 Post-Column Cond.
RP_OPCTag8 PostColumnCond
RP_DeviationHandlingType N/A
RP_DeviationEventType All Readings
RP_PerformedBy true
RP_CheckedBy true
RP_ECheckerProfile Supervisor
RP_VerifiedBy N/A
RP_ESignProfile None
ReadParam1 15.7
ReadParam2 N/A
ReadParam3 N/A
ReadParam4 N/A
ReadParam5 N/A
ReadParam6 707
ReadParam7 N/A
ReadParam8 N/A

Phase Manufacturing Instructions

Resource Name Operation Name Phase Number Phase Display Name
G2CEX-01 0130 (C. Loading_) 0140 Parameter Read

Manufacturing Instructions
Parameter Name Parameter Value
RP_GenericDescription N/A
RP_CanExecProfile Operator
RP_InstBold1 N/A
RP_Instruction1 Loading parameter read.
RP_SpecialHandling1 N/A
RP_InstBold2 N/A
RP_Instruction2 N/A
RP_SpecialHandling2 N/A
RP_UseOPCTagAlias true
RP_AutoExecutePeriodically true
RP_PollInterval 60

Page 10 of 13
 Recipe Header

Manufacturing Instructions
Parameter Name Parameter Value
RP_OPCSubtaskCaption Loading Parameter Details
RP_DescriptionParam1 Flow Rate
RP_OPCTag1 FlowRate
RP_DescriptionParam2 Pre-Column pH
RP_OPCTag2 PreColumnpH
RP_DescriptionParam3 Pre-Column Cond.
RP_OPCTag3 PreColumnCond
RP_DescriptionParam4 Pre-Column Temp.
RP_OPCTag4 PreColumnTemp
RP_DescriptionParam5 Column Inlet Press.
RP_OPCTag5 ColumnInletPressure
RP_DescriptionParam6 Volume Passed
RP_OPCTag6 VolumePassed
RP_DescriptionParam7 N/A
RP_OPCTag7 N/A
RP_DescriptionParam8 N/A
RP_OPCTag8 N/A
RP_DeviationHandlingType N/A
RP_DeviationEventType All Readings
RP_PerformedBy true
RP_CheckedBy true
RP_ECheckerProfile Supervisor
RP_VerifiedBy N/A
RP_ESignProfile None
ReadParam1 15.7
ReadParam2 N/A
ReadParam3 N/A
ReadParam4 N/A
ReadParam5 N/A
ReadParam6 N/A
ReadParam7 N/A
ReadParam8 N/A

Phase Manufacturing Instructions

Resource Name Operation Name Phase Number Phase Display Name
G2CEX-01 0150 (Goods Receipt) 0160 GoodsReceipt

Manufacturing Instructions
Parameter Name Parameter Value
RP_CanExecProfile Operator

Page 11 of 13
 Recipe Header

Manufacturing Instructions
Parameter Name Parameter Value
RP_ResourceTraining N/A
RP_OperationSOPTraining N/A
RP_Instruction1 Record quantity for goods receipt.
RP_SpecialHandling1 N/A
RP_DateTimeFormat dd/MMM/yyyy
RP_GROption MANUAL
RP_GRCalcFormula N/A
RP_PerformedBy true
RP_CheckedBy N/A
RP_CheckedByCaption Checked By
RP_ECheckerProfile None
GRQuantity N/A

Phase Manufacturing Instructions

Resource Name Operation Name Phase Number Phase Display Name
G2CEX-01 0170 (Status Update) 0180 ToBeCleaned Status Update

Manufacturing Instructions
Parameter Name Parameter Value
RP_GenericDescription N/A
RP_CanExecProfile ALL
RP_InstBold1 N/A
RP_Instruction1 Print "To Be Cleaned" label and attach to equipment's.
RP_SpecialHandling1 N/A
RP_InstBold2 N/A
RP_Instruction2 N/A
RP_SpecialHandling2 N/A
RP_LabelPrintRequired true
RP_ResourceTypeRoom true
RP_ResourceTypePrimary true
RP_ResourceTypeScale true
RP_StatusUpdateType Product Run
RP_SetState ToBeCleaned
RP_CheckClearanceValidity N/A
RP_ExpiryOverrideAuthProfile None
RP_UpdateInfoManually N/A
RP_PerformedBy false
RP_CheckedBy false
RP_CheckedByCaption Checked By
RP_ECheckerProfile None

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 Recipe Header

Manufacturing Instructions
Parameter Name Parameter Value
RP_VerifiedBy N/A
RP_VerifiedByCaption Verified By
RP_ESignProfile None

Phase Manufacturing Instructions

Resource Name Operation Name Phase Number Phase Display Name
G2CEX-01 0190 (Review Batch) 0200 Review Batch by Exceptions

Manufacturing Instructions
Parameter Name Parameter Value
RP_GenericDescription N/A
RP_CanExecProfile Supervisor,Operator
RP_InstBold1 N/A
RP_Instruction1 Review all exceptions before closing batch.
RP_SpecialHandling1 N/A
RP_InstBold2 N/A
RP_Instruction2 N/A
RP_SpecialHandling2 N/A
RP_DocLinkCaption1 N/A
RP_DocLinkURL1 N/A
RP_PerformedBy true
RP_CheckedBy true
RP_CheckedByCaption Checked By
RP_ECheckerProfile Supervisor
RP_VerifiedBy N/A
RP_VerifiedByCaption None
RP_ESignProfile None

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