Sop Cqa 102
Sop Cqa 102
Sop Cqa 102
limited
Format No.: C A/F/001, Vetsion:03 No.: SOP A/001
STANDARD OPERATING PROCEDURE
Operational Unit Corporate Quality Assurance SOP Number soP/cQA/102
Version 00
Tide
Process Order Cycle Execution in SAP Effective Date JUN Iz nn
PP module Review Date JUN Z I 2019
Page Numbet 7 of 12
1. OBJECTTVE
1.1. To give the ptocedure to establish a methodology for Execution/C rcrte/ Cbange/Display of
Process Otdet fot Bulk Drug Semi-finished Goods, Finished Goods-Export, pinished
Good-Domestic, and Finished Goods-Physician Sample in SAP.
2. SCOPE
2.1. Applicable to the activity fot Execution/Crcate/Ch*ge/Display of Ptocess Otder by
Ptoduction xld planl QA depatrnent in SAP [Systems, Applications, Ptoducs (in &ta
processing), DATA Base S/4 HANA, aod Version No.1511]
3. RESPONSIBILITY
3.1. f6cer D
3. 1. 1.
To Execute / Crezte / Chatge,/Display of Process Order
3.2. Manager/Designee- Ptoduction:
3.2.1. Responsible to check process otdet.
3.3. Head/Desisnee- Production:
3.3.1. Responsible to veri$ the ptocess otder.
4. PROCEDURE
4.1. SAP Softwate sart up:
4.7.7. SAP sysytem shall be open by double click on System Application Ptoducts (SAP)
icon- the svstem disDlavs "SAP Loson". Gioue 1 of Annex - fV).
4.7.2. User to ptovide the details such as'IJset name', ?asswotd'and T,ocation name',
system displays the "Home" screen (Figure 2 of Annex - IV).
4.2. To view Process order no. fot mfg. of SFG (COOISPD
4.2.7. Enter ttansaction T-code'COOISPf in SAP navigtion and press 'Entet' key,
system display ?rocess otder infornation system' screen. figue 3 of Annex- 19.
4.2.2. Select SFG code.
4.2.3- Select t and click on '{' or ress'Enter'
Prepated by Checked by Authorized by
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Date
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Name P C More G S Mhasde S V Pohnetkar s
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4.2.4, Select order type as ?tocess Ordel and click on '{' ot ptess 'Entet' key.
4.2.5. Click on'Execute'8' Synbol ((Figure 4 of Annex- M.
4.2.6. List of ptocess ordet aga.inst matedal numbet will displayed. (Figue 5 of Annex-
rvl.
4.3. with 'CRTD' status for SFG (COR2)
Proces to release the Ptocess order
4.3.1. Enter transaction code'COR2'in SAP navigation and press 'Entet' key. Obo" 6
of Annex- fV).
4.3.2. Window shall show 'Change ptocess otded scteen.
4.3,3. Select'ptocess ordet numbet' and ptess 'Eotet'key. ftgure 7 of Annex- ID.
4.3.4. Check total quantity aod scheduled dates in'General data'. (Figure 7.1 of Annex-
nn.
4.3.5. Click on Matedal icon "ffi' to check matedal availability.
4.3.6. In case of non-availability of matedal Window will show Availability check scteen.
ftgure 7.2 of Annex- [D.
4.3.7. Check missing parts list in availability check and click on back symbol 'tQ".
(Fioure 8 of Annex- fV).
4.3,8, Message will confi.med that all checked materials are available in case all matedals
are available fot that process otder w.r.t.otdet quantity.
4.3.9. Select'Goo&Receipt'view.
4.3.10. Click oo 'Create batch' icoo "8I".
4.3.77. Window will show SAP generated Batch number. (Figure 9 of Annex- ID.
4.3.72. Click on '8" icon to view Matedal Lisd.
4.3.13. Window will display 'Raw Matetial list/packing material list'. (Figure 10 of Annex-
nn.
4.3.74. Click on '{El- icon and 'select All' &6 m2lsriels. @igute 11 of Annex- IVJ.
4.3.15. Click on "8" icon and Execute Batch Detemiratioo'.
4.3.76. Batch Determination will show batch details of speciEc raw matedal.
Signature
Date
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4.3.17. Click on'Batch Determntn:' system will fetch the respective SAP batch No. with
tequired quantity wittr FEFO ot FIFO logic. (whichevet is applicablQ
4.3.18. Click on'frI" icon and copy the batch. @igure 12 of Annex- ID.
4.3.79. Batch numbet of all the mw rnate;rls were copied and displayed.
4.3.20. Click oo "t-i' icon and telease the process ordet. Message will generate in status
bar as 'Release carried out .
4.3.21. Click on " E " symbol and ptocess order will saved successfrrlly.
4.4. To assiga Manufacturing & Expiry date to the Betch we need to use T-code MSC2N.
4.4.1. The Batch Manufacnuing Date shall be the Ptocess Otdet rcleased Date.
4.4.2. The Batch Expiry &te shall be based against the Standard Shelf Iife (will be
captured ftom Mastet Data) and Process Order Released Date (\,Ifg. datQ
combination.
4.4.3. The Batch Expiry date shall be based on total Shelf Life maintained in the mzrterial
-rster field calculated ftom the &te of Matetial Dispense fot the given Order &
batch for the Export Materials.
4.4.4. E.g. If the shelf life of the ptoduct is 24 months and the temaining shelf life of API
is 18 months, then shelf life of the Erished product shall be given as 24 months.
4.4.5. In case of domestic products, the shelf life of the ptoduct shall not exceed the shelf
life of the API.
4.4.6. E.g. If the shelf life of tle product is 24 mooths and the temaining shelf life of API
is 18 months, then shelf life of ttre finished product shall be given as 18 months.
4.4.7. Enter Eansaction code 'I\,ISC2N' in SAP navigation and press Entet'key.
4.4.8. Window will display 'Chaoge batch screen'
4.4.9. Enter the SFG code. Batch flo. plant code. (Figue 15 of Annex- I9.
4.4.70. Eoter the date of manufacturing and ptess enter. (Figure 15.1 of Annex- ID.
4.4.77. The system shall auto calculate the Expry Date fot the batch w.r.t. standard shelf
life mainained in tlle Material Master.
4.5. Vedfication of process older to be taken on system generated ptint of "Material requisition
note" ormat No.: CQA/F /17
Prepared by Checked by Authorized by
Signature
Date
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Format No.: C A/F/001, Vetsion:03 JoP No.' SoP/ C A/001
STANDARD OPERATING PROCEDURE
Operational Unit Corporate Quality Assurance SOP Numbet soP/cQA/102
Vetsion 00
Effective Date JUN 2 2 ?017
Process Order Cycle Execution io SAP
Tide
PP module Review Date JUtl 2 't 2019
Page Number 4of72
4.5.1.
Material tequisition note to be checked by ptoduction Managet/Designee for
adequacy against the batch manufacturing record and to be veriS by ptoduction
Head/ Designee.
4.6. RM/PM Extta Issuance against process ordet.
4.6.1. Erter traosaction code'COR2'in SAP navigation and ptess Entet'key. (Figute 20
of Annex- [D.
4.6.2. Window will display 'chaoge ptocess otder initial screeo-. (Figute 21 of Annex- 19.
4.6.3. Select the process order no.
4.6.4. Select & Copy the materirl which is required as extm matedal against the operation
phase, Change the sedes of the Item Initiating with 8000, put required Extra Qty of
the matedal. $tsxe 22 of Annex- fVl.
4.6.5. Select the material which is to be tequired extra fot SAP batch determination.
4.6.6. System will select ttre batch as pet FEFO/FIFO. Press copy icon. (Figue 23 of
Annex- IV).
4.6.7. System will auto select ttre batch. Press saves. (Figue 24 of Annex- I\1.
4.6.8. Take the "Excess Matetial Reservation Note" print using ZPP001 T-code.fonnat
No.: CQA/F/175).
4.7. Select and co.fi- the Opetation phase aftet activity completion.
4.7.7. Enter transaction code'COR6N'in SAP navigation and press Entet'key. (Figure
25 of Annex- IVl.
4.7.2. Window shall show 'Enter time ticket for ptocess otdet' scteen.
4.7.3. Entet ?rocess otdet number'.
4.7.4. Select the ?hase' (E.g. 0010-Sifting tef. ftom mastet recipe). (Figure 26 of Annex-
n1.
4.7.5. Click on '*re" icon and Ptopose'Actual &ta. Click on yield to get
opemtion phase details and save the phase detafu. Ptgarc26.1of Annex- I9.
4.7.6. Select next'Opetation Phase' (e.g. 0020- Siftingl &om tef. recipe) and repeat same
procedure as mentioned above until cover all the optation phases.
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Date .Jc.r''ul,>ol+ fu'u4 t-t, :f(n 2J
Name P C Mote G S Mhasde S V Pohnerkat
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Designation Executive-Production Manager-CQA Asst. Gen Manager-CQA
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Format No. 'A/F /001, Vetsion:03 Reference SOP No.: SOP/ C A/001
STANDAR-D OPERATING PROCEDURE
Operational Unit Corpotate Quality Assurance SOP Number soP/cQA/102
Vetsion 00
4.7.7. Click on 'irc" icon aad ptopose actual daa. Click on yield to add
oPeatation Phase det'ils.
4.7.8. Add 6oal yield and con6* the OPradon Phase derails.
4.7.9. Click on "E" symbol and save the phase deails. (Frg*" 26.2 of Annex- 1V).
4.7.10. Qldet s6n6rmatien for that particular phase will saved.
4.8. Ptocess Qldsr sslfiftnation cao be done by Mile Stone ot Opemtional confirmation.
4.9. SFG transfer ftom Production to Watehouse (Goods Receipt- MIGO). F'tguie 29 of Amex-
tr4.
4.9.1, Enter taosaction code MIGO'in SAP navigation and ptess 'Ente/ key.
4.9.2. lTiodow will show 'Goods teceipt otdet' scteen.
4.9.3. Select ftansaction/Event- A01 Good receipr
4.9.4. Select reservation type- R08 otder.
4.9.5. Entet process ordet numbet and press Eoter' key. (Figure 30 of Annex- IV).
4.9.6. Window will show SFG detqils in general &ta.
4.9.7 . Select 'Storage location' in !7hete view.
4.9.8. Entet 'Goods teceipt name'.
4.9.9. Entet 'IJploading point'.
4.9.10. Add Date of Manufactidng' and 'SLED/BBD' 1o 3rtc5 ds ils viev.
4.9.17. Tick mark'{'on Item OK.
4.9.12. Click on "GEEtr" icon and Check the entties. @igure 30.1 of Annex- I9.
4.9.13. Window will display a message to cofiect the eror or to 6ll missed 6elds,
4.9.74. Resolve all the issues aod firrther check the eotries. (Figure 30.2 of Annex- [D.
4.9.15. Message will genetate Document is OIC.
4.9.16. Click on'{Etr" icon and post all the documents.
4.9.17. Message confimred that SFG matedal document posted successfl Iy. (Figue 30.3
of Annex- 19.
4.10. SFG Stock overview (IvIlvIBE)
Signature
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A/F/001, Vemion:03
Format No.: C fi.eferen.. foP No.: SoP/ C A/001
STANDARD OPERATING PROCEDURE
Opemtional Unit Corporate Quality Assurance SOP Numbet soP/cQA/102
Version 00
4.10.1. Enter transaction code 'MMBE'in SAP navigation and press 'Entel key. figure 31
of Annex- IV).
4.70.2. lUindow will show Stock Overvied initial scteen.
4.10.3. Eotet 'SFG material code'.
4.10.4. Select the ?lanC and click ou '{' or press 'Enter' key. (Figure 32 of Arurex- ID.
4.10.5. Click on "II" symbol and Execute the stock.
4.10.6. Stock overview basic list.
4.10.7. Displayed the stock aftet SFG Manufactudng. @tgure 33 of Annex- IV).
4.11. To view FG for Produced SFG (CS15)
4.17.7. Entet transaction code'CS15'in SAP navigation aod press'Ented key.
4.77.2. Window will show q$7hete- Used List Matedal'initial sceen.
4.17.3. Enter'SFG materid code'.
4.17.4. Select 'I\,Iatedal BOM'.
4.17.5. Select the'Type of whete used lisd and add valid to date.
4.77.6. Click on iE' symbol to go for next scteen.
4.17.7. Vlhere-Used T;st: Matedal View.
4.11.8. Select the Plant and click on '{' or pr.." 'Ented key.
4.77.9. Click on E symbol and Execute the materid list.
4.77.70. Material whete-Used List will displayed.
4.12. To view the BOM of SFG aod FG (CS11)
4.72.1. Entet ttansaction code 'CSl f in SAP navigation and press 'Enter' key.
4.72.2. Window will show 'Explode BOM: Level by Level initial scteen.
4.72.3. Entet FG mrterial code.
4.12.4. Entet the plaat and click on '{' or ptess 'Enter' key,
4.12.5. Select tsOM application' and click on '{' or press 'Enter' key.
4.72.6. Click on {E symbol aod Execute the BOM.
4.72.7. I7indow shell display BOM I*vel by Level.
4.13. To view Ptocess otdet no. fot mfg. of FG (COOISPI):
Signature
Date
Name
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Format No.: C A/F/001, Vetsion:03 fr"f"."o." No.: soP/ A/001
STANDAR.D OPERATING PROCEDURE
Operational Unit Corporate Quality Assurance SOP Number soP/cQA/102
Version 00
4.73.7. Entet traosaction code 'COOISPI'in SAP navigation and press 'Entet' key. (Figure
3: of A-onex- [9.
4.13.2. Window shall display Process ordet information system screen.
4.13.3. Eoter 'FG matedal code'.
4.73.4. Enter the pl,n121d click on '{' or press 'Entet' key. @igure 4: of Annex- ID.
4.13.5. Select ordet type as process otdet and click on '{' ot ptess 'Entet'key.
4.13.6. Click on {5' symbol aud Execute the ?tocess ordet'list (Figue 5: of Annex- I9.
4.73.7. Process order list "fi"st FG materid code shall be displayed.
4.14. Ptocess order Release ptocedure for FG (COR2)
4.74.7. Entel ftansaction code'COR2'in SAP navigtion aod press 'Enter'key. (Figure 6:
of Annex- [D.
4.74.2. Window will show Change ptocess otdet sceen.
4.14.3. Entet ?tocess otder number'aod press 'Ente/ key. g*. 7: of Annex- [D.
4.14.4. Check toal quantity and scheduled &tes in'Genetal &ta'. @igute 7.1: of Annex-
I\r,}.
Signatute
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Format No.: C A/F/001, Version:03 fi..f.r.n.. {oP No.: SoP/ C A/001
STANDARD OPERATING PROCEDURE
Operational Unit Corporate Quality Assurance SOP Number soP/cQA/102
Version 00
Signature
Date
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Name P C More G S Mhasde S V Pohnerkar s
Designation Executive-Production Managet-CQA Asst. Gen Manager-CQA
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Format No.: C A/F /001, Version:03 Reference SOP No.: SOP/ C A/001
STANDARD OPERATING PROCEDURE
Operational Unit Corporate Quality Assurance SOP Number soP/cQA/102
Yersion 00
4.18.6. Now click oo 'G' to check the entdes ,'',de in the sceen. (F-tgote 28.2 of.
Annex-fV)-
4.18.7. Click oo "E" symbol and save 1f,s dgtails.
4.18.8. Use the document No. fot'.I\,Iaterial Retum Note" rrith T-code ZPP001. (Fomat
No.: CQA/F/176).
4.18.9. Select the paticulats as shown & click on Execute button.
4.19. FG transfer ftom Packing to rJTarehouse (Goods Receipt-MIGO)
4.19.7 Enter transaction code anIGO' in SAP navigation and ptess 'Entet' key. Figute 29
of Annex-IV).
4.79.2. Window will show 'Goods teceipt otdet' scteen.
4.19.3. Select uansaction/Event- A01 Goods receipt.
4.19.4. Select reservation type- R08 otder. (Figure 30: of Annex-
4.19.5. Enter process order number and press 'Enter' key.
4.19.6. Entet the full shipper quantity against the "Unloading Point" & loose shipper
quantity & Quality sample quantity again5l dls 'Text" figue 30.1 of Annex-ID.
4.19.7. Window qrill show FG details in general data. Tick '''e'k'{'as ok and click on
" icon. (Fioure 30-2 of Annex-IV)
4.19.8. Window will display a message to corect the errot or to fill missed 6elds.
4.79.9. Click on '@1" icon and post all the documents. (Figute 30.3 of Annex-I9.
4.19.10. Message conErmed that FG matetial document posted successfirlly.
4.79.77. Use T-code 'ZMM3U. to print '?acking Slip"- pto6rr.Oon Copy format No.
CQA/F /177) and '?acking Slip"- 16'rt 5oore Copy (Format No. CQA/F/178)
Gioure 30.4 - Fisue 30.5 of Annex-[V).
4.79.12. Finished goods transfer to wnehouse along with packing SIip and ackonwledge
packing slip- production copy form watehouse department.
4.20. FG Stock overview (MMBE)
4.20.7. Ertet Eansaction code WMBE'in SAP navigation and press 'Entet'key. (Figue 31
of Annex-ID.
Signatue
Date
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Format No.: A/F/001 Vetsion:03 No.: SOP A/001
STANDARD OPERATING PROCEDURE
Opetational Unit Corporate Qudity Assuance SOP Number soP/cQA/102
Version 00
Effective Date JUN 2 ? 2011
Process Order Cycle Execution in SAP
Tide
PP module Review Date JUtt 2 r 20lg
Page Number 10 of 12
Signatute
Date
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Format No.: C A/F/001, Version:03 S No.:
STANDARD OPERATING PROCEDURE
Opetational Unit Corpotate Quality Assurance SOP Number soP/cQA/102
Vercion 00
Process Otdet Cycle Execution in SAP Effective Date JUtl " 2 ?017
Title
PP module Revieqr Date JUil 2 1 20lg
Page Numbet 11 of 12
5. REI.ATED DOCUMENTS
5.7. Ni].
6. REFERENCES
6.7. Nit.
7. RECORDS
7.7. Annex- I: Scteenshot fot Ptocess Order Cycle in SAP PP module
7.2. Format no.: CQA/F /174'Matetial tequisition note"
7.3. Fomat no.: CQA/F /175 "Excess Material Resewadon Note"
7.4. Fotmat no.: CQA/F/176 'Matetiol Retum Note"
7.5. Format no.: CQA/F /177 '?acking SIip" Production Copy
7.6. Fomat no.: CQA/F/178 '?agking Slip" r00arehouse Copy
Signature
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8. REVISIONRECORI)
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Fotmat No.: C A/F /17s Version No. 00
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Reference SOP No.: SOP/C A/102
Aianta Pharma Limited
Excess Material Reservation Note
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Format No.: C /F /176 Version No. 00 Refetence SOP No.: SOP/C /102
Ajanta Pharma Limited
Material Return Note
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Aianta Pharma Limited
Packing Slip
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Format No.: C A/F / 778,Yetsion No- 00 No.: A/102
Alanta Pharma Limited
Packing Slip
Watehouse Copy
Packaging Officer
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ANNEX-IV
SAP
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ANNEX-IV
Screenshot for Ptocess Otdet Cycle in SAP PP module Page No.:2 of56
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