Application of SAP in pharmaceutical

System application and product in data processing (SAP) is a real time business software founded by five former IBM employee in 1972. it is available in 14 language with worldwide market share of 31%.it is a 8 th of top largest software company. the most important advantage of it real time processing.it is fourth largest independent software supplier company of the world.uses of SAP makes it possible to track and manage, in real time, sales,production,finance,accounting and human resource in an enterprises. there are various module in SAP list below
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SAP modules

FI (finacial accounting)

CO (controlling)

AM (asset managment)

PS (projection system)

PS (Project System)

WF (Workflow)

IS (Industry Solutions)

HR (Human Resources)

PM (Plant Maintenance)

MM (Materials Management)

QM (Quality Management)

PP (Production Planning)

SD (Sales and Distribution)

symbols or icon are used in SAP to command various functions. some of the important Icons are given in below image.

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SAP icons

the use of SAP is vast area so we are going to discuss a few important module which is used in pharma.

1. Material management: supports the procurement and inventory functions occurring in day-to-day business operations such as purchasing, inventory management, reorder point processing, etc.

Transaction codes for Material management

MM01 to create material master

MM02 to change material master

MM03 to display material master

MB21 to create reservations

MB22 to create reservations

MB23 to display reservation

MB25 list of reservation

ME51n to create purchase requisition(PR)

ME52n to change PR

ME53n to Display PR

migo to create good receipt

mmbe to check stock availability

mb51 to stock ware house

mb1b for transfer posting

Material managment in SAP start from Material master creation, material master created for

ROH - Raw Material

ZPPM - Primary Packing Material

VERP - Packaging Material

HALB - Semi finished Goods

FERT - Finished Goods

ERSA - Spare Parts

UNBW - Non Valuated Materials

ZSCP - Scrap Material

FHMI - Production Resources and Tools

Material master contain a variety of important data in a single code used for various activity such as planning, purchasing, production, quality control etc.

There are following views to be maintained in Pharmaceuticals.

1. Basic data 1 & 2

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MM views

2. Classification

3. Foreign trade import

4. Purchase

5.MRP 1, 2,3 and 4.

6.General plant data /storage 1

7.Quality management

8. Accounting 1 and 2

9. costing 1 and 2

A unique Number for material master generated through SAP, this code is used for Purchasing by order after purchase order material received by warehouse. ware house officer generated a good receipt (GR) through SAP and the material moved to under test area for inspection by Quality management person.

2. Quality managment: is a quality control and information system supporting quality planning, inspection, and control for manufacturing and procurement.

Transactions codes for Quality mangment

Overview of QM

QA01 Create Inspection Lot

QA01A Create Inspection Lot

QA02 Change Inspection Lot

QA02A Change Inspection Lot

QA03 Display inspection lot

QA05 Job planning:Periodic inspection

QA06 Job overview: Periodic inspection

QA07 Trigger for recurring inspection

QA07L Deadline Monitoring Log

QA08 Collective Processing of Insp. Setup

QA09 No. range maintenance for insp.lots

QA10 Trigger automatic usage decision

QA10L Log for Automatic Usage Decision

QA11 Record usage decision

QA12 Change usage decision with history

QA13 Display usage decision

QA14 Change UD without history

QA16 Collective UD for accepted lots

QA17 Job planning for auto usage decision

QA18 Job overview for auto usage decision

QA19 Automatic usage decision

QA22 Change inspection point quantities

QA23 Display insp.point quantities

QA32 Change data for inspection lot

QA32WP QA32 -Call from Workplace/MiniApp

QA33 Display data for inspection lot

QA40 Auto. Usage Decision for Production

QA40L Log for Automatic Usage Decision

QA41 Scheduling UD for Production Lots

QA42 Job planning: UD prod. insp.lots

QA51 Scheduling Source Inspections

QA52 Source inspections: Job overview

QAC1 Change insp. lot actual quantity

QAC2 Transfer stock to insp. lot

QAC3 Reset sample

QAER Display archive objects

QAS1 Download Insp. Specs. (Obsolete)

QAS2 Download Basic Data (Obsolete)

QAS3 Upload Results (Obsolete)

QAS4 Upload UD (Obsolete)

QC01 Create certificate profile

QC02 Change certificate profile

QC03 Display certificate profile

QC06 Immediate delete of cert. profiles

QC11 Create cert. profile assignment

QC12 Change cert. profile assignment

QC13 Display cert. profile assignment

QC14 Create cert.prof.assign.w/copy model

QC15 Create cert. profile assignment

QC16 Change cert. profile assignment

QC17 Display cert. profile assignment

QC18 Create cert.prof.assign.w/copy model

QC20 Certificates for Deliveries

QC21 Quality certificate for the insp.lot

QC31 Archive display: Delivery item

QC32 Archive display: Inspection lot

QC40 Internet Certificate for Delivery

QC40A Internet Certificate for Delivery

QC42 Batch certificate on WWW

QC51 Create certificate in procurement

QC52 Change certificate in procurement

QC53 Display certificate in procurement

QC55 Worklist: Certificates - Procurement

QCC0 QM: Direct Access to IMG

QCC1 Direct Access to IMG: Notification

QCC2 IMG Direct Access: QM Q-Notification

QCC3 IMG Direct Access: QM Q-Inspection

QCC4 IMG Direct Access: QM Q-Planning

QCC5 IMG Direct Selection: QM Bus. Add-In

QCCC QM standard settings complete

QCCF QM standard forms

QCCK QM standard settings: Catalogs

QCCM QM std. settings: Qual. notifs.

QCCN QM standard number ranges

QCCP QM std. settings: Quality planning

QCCS QM sampling schemes

QCCT QM standard texts

QCCU QM standard settings: Environment

QCCW QM std. settings: Quality inspection

QCCY Transport QM tolerance key

QCCZ QM std. settings: Qual. certificates

QCE2 Edit Communication Support

QCE3 Display Communication Support

QCYF QM standard forms (general)

Master data for QM

1. Master inspection characteristic: It is parameters of specifications to be inspected, e.g. Assay. Generally two type of MIC 1) Quantitative and 2) Qualitative characteristics Quantitative characteristic will have upper/lower value and qualitative have a selective sets.

• Transaction code

QS21 to create MIC

QS23 to change MIC

QS24 to display MIC

the process of creation of MIC is very easy there are two types of MIC 1) Qualitative and 2) Quantitative. Qualitative means it not contain any numerical value and show some characteristic eg complies, not complies, accepted and rejected etc. these characteristics are know as selective sets , created by TR code qs41.

use transaction code QS21 after that a screen to be appeared fill some important field mentioned below

1.A specific code to be assign to MIC by filling blank field MIC as per SOP.

2. Status as released

3.Select Qualitative or Quantitative if qualitative select selective sets or Quantitative selects Limit that is upper limit or lower limit options.

4. fill search text option that describes the codes in text.

5. Finlay save the MIC.

MIC is used during creation of inpection plan so that it is necessary to create MIC before inspection plan.

2. Inspection Plan: Materials are tested in pharma as per specification and testing method, specification contain testing characteristic such as Assay, LOD etc. and Limit , same as specification Inspection plan is created in SAP attached to every materials to be tested. after material master has been created it under Status of created and after assignment of Inspection plan it moved to release.

Transaction code

1. QP01 to create

2. QP02 to change

3. QP03 to Dis ply

Step 1 enter transaction code qp01 next screen appear as under

Inspection plan screen 1

Step 2 fill box in front of material for which inspection plan to be created and plant code.

Step 3 Enter next screen appear as under

Inspection plan screen 2

Step 3 fill the boxes in front of Usage-5 as good receipt and Status-4 as released.

click on the tab Operation appear in a picture next screen appear

Inspection plan screen 3

Step 3 fill control key, plant code and Operation as appear in screen shows the two types of operation sampling and Other test. select one operation and click on tap inspection characteristics, next screen appear as under

Inspection plan 4

Step 4 fill the MIC as per below screen

Inspection plan5

For each Quantitative test Following screen appear so fill Lower spec and upper limit and decimal point and Unit of measurement.

for Qualitative test select selective sets instead of limit finally save the inspection plan.

3.Quality Info record: it is an approval of vendor for procuring material from Quality department, without QI record it is not possible to create purchase order to procure.

Transaction code

qi01 to create

qi02 to change

qi03 to display

Step 1 use TR code QI 01 and fill material code Vendor code,plant as appear in following screen

Enter next screen appear as follow

fill the Release until date and click on insp. control tab and select vendor validated by QC

finally save, QI has been created.

4. Inspection lot selection: it is a list of of material shows the current status such as REL, INSP, LTCA, UD etc. if the material is under REL status means the material need to be inspected so that QC find the actual status of material and plan to inspection. after inspection it moved to status INSP and UD after usage decision made.

Transaction code:
1.QA33 for display
2. QA32 for Change

Step 1. use TR code QA32 next screen appear as under

Step 2 Fill the blank box in front of Plant, inspection lot origin and execute to show the list of status for material.
Inspection lot origin: 01 for RM and PM, 03 for In process materials, 04 for FG and 09 for retest materials.

find the status of material and do the further action such as result recording or usage decision.

4. Result recording:for making final decision of material by quality department judge by the result recorded. so result recording is an important process that show the actual result of material tested, and it is accepted or rejected on the basis of result.

Transaction code:
1. QE01 for result recording
2. QE02 for result recording change
3. for Display

Step 1 use TR code QE01 and next screen appear as under

Step2 Fill the inspection lot and operation next screen appear as under

Step 3 fill or select the result one by one and click on select all tab and the Evaluate tab and lock button.
Step 4 Save the result.

5. Usage decision: it is the decision made by Quality departmet for any material, intermediates and FG for their further use by selecting accept or reject and other options base on result as recorded in result recording.

TR code: QA11

Step 1 use TR code QA11 next screen appear as under

step 2 fill inspection lot and enter next screen appear

Step 3 select the ud code by drill down tab of UD code and click on inspection lot stock screen appear as under

Step 4 Distribute total quantity of material accordingly and save.

Next to be update................................

regards
Arif khan
www.facebook.com/arif.khan3333333333

Application of SAP in pharmaceutical

Friday, May 4, 2012

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