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Doc. ID.: xxx/yyy Version: 1.0 QC Labels Functional Specification – Forms Date: Signature: Author: Mayank Mevcha Technical Expert Approval: Page: 1 / 28

Functional Specification 03

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Page 1: Functional Specification 03

Doc. ID.: xxx/yyyVersion: 1.0

QC Labels

Functional Specification – Forms

Date: Signature:Author:

Mayank Mevcha

Technical Expert

Approval:

Page: 1 / 23

Page 2: Functional Specification 03

Doc. ID.: xxx/yyyVersion: 1.0

Document history:

Version

Date Author CR Comments

1.0 Mayank Mevcha E0014028

Initial Version

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Table of Contents

1 OVERVIEW.............................................................................................................................4

2 FUNCTIONAL SPECIFICATION.................................................................................................4

2.1 Label Types......................................................................................................................................... 42.2 Selection Fields - Details.....................................................................................................................52.3 Selection Fields - Functionality............................................................................................................52.4 Selection Fields Matrix......................................................................................................................... 62.5 Restrictions.......................................................................................................................................... 62.6 Error Messages................................................................................................................................... 72.7 Rules for Printing................................................................................................................................. 82.8 Label Content Matrix.......................................................................................................................... 102.9 Content Description........................................................................................................................... 112.10 Label Layouts.................................................................................................................................... 122.11 Label Fields....................................................................................................................................... 14

3 Further information.............................................................................................................23

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1 Overview

Purpose of output program/Query

The purpose of the adaptation is to print Quality Status Labels and Physical Samples Labels and to develop a custom specific labelling transaction for print, re-print, error handling and label history.

These labels are necessary to show usability of materials and physical samples in the warehouse and in the laboratory.

Business owner Local Quality Assurance

2 Functional specification

Business objects All created QC labels and physical sample labels.

Trigger for output Depending on the inspection creation, there are different triggers for Label Printing:

- Goods Receipt for Purchase Order- Goods Receipt from Process Order- Other Goods receipts- Recurring Inspection - Transfer Postings- Manual inspection lot- Manual printing request (to reprint the labels)- Stability studies Inspection Lot- Reserve sample labels

Type of LabelsThere are 9 different type of label layouts:

2.1 Label Types

Sr.No Label Type

Description

1 0102A Approved label for incoming materials (raw and packaging materials)

2 0102B Approved label for Bulk/FDF/AI Materials

3 0102C Rework Label

4 0103A Rejected label for incoming materials (raw and packaging materials)

5 0103B Rejected label for Bulk/FDF/AI Materials

6 0201 Samples labels for Raw/Packaging

7 0202 Samples labels for Bulk/FDF/AI

8 0203A Reserve sample labels for Raw/Packaging

9 0203B Reserve sample labels for Bulk/FDF/AI

10 0204 Stability sample labels

Data Selection (Input) A new custom developed transaction will be created.

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2.2 Selection Fields - Details

Length Description Comments / Format

4 Plant Plant ID (WERKS)

12 Inspection Lot Inspection Lot Number (PRUEFLOS- QALS)

5 Label typeThis is custom character field. It Must be stored in z-table. Descriptions should be in English language.

8 Quantity per Container Numeric, Manually entered at selection screen

4 Number of containersNumeric, Manually entered at selection screen

4 Total nr. of labelsNumeric, Manually entered at selection screen

4Printed Number of labels

Numeric, Manually entered at selection screen

4Number of labels to print

Numeric, Manually entered at selection screen

1 Reprint Flag F: First Print; R: Reprint

2.3 Selection Fields - Functionality

Selection

Field #

Content Functionality

1. Plant Mandatory input field for label printing

2. Inspection Lot Number

Conditional mandatory field to gather all relevant information required for label printouts. Select from the list or input manually.

(inspection lot number or material doc. number must be entered)

3. Posting Date Posting Date is a Optional label attribute and input field.

4. Label Type Mandatory field for label printing

5. Number of Containers

Total number of containers in related batch (mandatory for label types 0102A, 0103A and 0201)

6. Total nr. Of Labels Total number of labels that have been printed (mandatory for label type 0102A, 0103A, 0201)

7. Printed no. of Labels (used as counter/sequence)

Number of the labels that are printed before (mandatory for label type 0102A, 0103A, 0201,0202, 0203A, 0204)

8. Number of Labels to print

Number of the labels that will be printed now (mandatory for all label types)

9. Reprint Flag F: First Print; R: Reprint, Mandatory field

10. Comment Short text or Remark to enter re-print

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reason or Other information

11. NO Printer dialog Indicator to activate or not the printer dialog

2.4 Selection Fields Matrix

Input / Label Type

Sam

ple

d-R

M

Sam

ple

d-F

P

Re

serv

e S

amp

le-R

M

Re

serv

e S

amp

le-F

P

Sta

bili

ty

Sam

ple

Ap

pro

ved

-RM

Re

ject

ed-R

M

Ap

pro

ved

-FP

Re

wo

rk

Re

ject

ed-F

P

 02

01

0202

0203

A

0203

B

0204

0102

A

0103

A

0102

B

0102

C

0103

B

Plant M M M M M M M M M MInspection Lot Number M M M M M M M M M MLabel Type M M M M M M M M M MNumber of Containers M O  O   O O M M O  O OTotal nr. Of Labels M O  O  O O M M O O  OPrinted no. of Labels M M   M  O  M M M O O O 

Number of Labels to print M  M M M M M M M M M

Reprint Flag M  M M M M M M M M M

Comment* O O O O O O O  O  O  OM= Mandatory, O = Optional* Mandatory in case of reprint.

2.5 Restrictions

Number of Label = A

No. of Containers = B

Printed No. of Labels = C

Total No. Of Labels = D

Label type 0101: A <= (B-C)

Number of labels must be smaller or equal to No of containers – Printed no of labels. Give Error message if condition is not met.

Label type 0102A: A <= (D-C)

Number of labels must be smaller or equal to Total no of labels – Printed no of labels. Give Error message if condition is not met.

Label type 0103A: A <= (D-C)

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Number of labels must be smaller or equal to Total no of labels – Printed no of labels. Give Error message if condition is not met.

Label type 0201: A <= (D-C)

Number of labels must be smaller or equal to Total no of labels – Printed no of labels. Give Error message if condition is not met.

Label type 0202: A <= (D-C)

Number of labels must be smaller or equal to Total no of labels – Printed no of labels. Give Error message if condition is not met.

Label type 0203A: B >= (D+C)

Number of Containers must be larger or equal to Total no of labels + Printed no of labels. Give Error message if condition is not met.

2.6 Error Messages

The Z-Table must be maintained for Plant wise, Label Wise Error Messages.

Field value VCODE-QAVE

Label Type

Program Result

Q,I or if the field is empty 0101 No error message

Q,I or if the field is empty 0102* Error message: ‘Please check the usage decision status’

Q,I or if the field is empty 0103* Error message: ‘Please check the usage decision status’

Q,I or if the field is empty 0201 No error message

Q,I or if the field is empty 0202 No error message

Q,I or if the field is empty 0203 No error message

Q,I or if the field is empty 0204 No error message

A, C, P, N, T, S, U 0101 No error message

A, C, S 0102 No error message

E, I, R, T, U 0102A/B

Error message: ‘Please check the usage decision status’

A, C, P, N, T, S, U 0103* Error message: ‘Please check the usage decision status’

A, C, P, N, T, S, U 0201 Error message: ‘Please check the usage decision status’

A, C, P, N, T, S, U 0202 No error message

A, C, P, N, T, S, U 0203* No error message

A, C, P, N, T, S, U 0204 No error message

W 0101 No error message

W 0102A/B

Error message: ‘Please check the usage decision status’

A,C,E,N,P,Q,R,S,T,U 0102C Error message: ‘Please check the usage decision status’

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W 0103* Error message: ‘Please check the usage decision status’

W 0201 No error message

W 0202 No error message

W 0203 No error message

W 0204 No error message

E, R 0101 No error message

E, R 0102A/B

Error message: ‘Please check the usage decision status’

E, R 0103* No error message

E, R 0201 Error message: ‘Please check the usage decision status’

E, R 0202 No error message

E, R 0203 No error message

E, R 0204 No error message

* applicable for type A & B

Processing logic In general the source of information shall be the initial document (e.g. Inspection Lot) and the matchcode. All available information should be copied from these documents.

User must be forced to enter 'R' in reprint flag field after first print.

Tables to get the needed data:QALS Inspection Lot TableQAVE Usage Decision Table QPRS Master record for physical samples

Program will take the inspection lot number entered in the selection screen and check the inspection lot decision (VCODE-QAVE) and the label type (field from z-table) and should block further processes for the below situations (same scenarios are combined in one row therefore for the VCODE field, it is enough to have one of those values).

2.7 Rules for Printing

The Z-Table will be created, in order to maintain valid Plant/Material Type combinations for printing.

Sample Label – RM (label type 0201) can only be printed if the material types are: ZAPI, ZRAW, ZPKB, ZPKS, and ZPPP. Otherwise an error message is generated.

Print an additional Sample Label when the sequential number of containers is equal to the total number of containers

Approved label – RM (Label type 0102A) for incoming materials (raw and packaging materials) can only be printed if the material types: Z010, Z020, Z030, Z040, ZAPI, ZBUL, ZRAW, ZPKB, ZPKS. Otherwise an error message is generated. The values for Assay and Water must be retrieved from the Z-table maintained for MIC.

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Rejected label – RM (Label type 0103A) for incoming materials (raw and packaging materials) can only be printed if the material types are: Z010, Z020, Z030, Z040, ZAPI, ZBUL, ZRAW, ZPKB, and ZPKS. Otherwise an error message is generated

Sample label - FP (label type 0202) can only be printed if the material types are: Z010, Z020, Z030, Z040, ZINS, ZINT, ZBUL, and ZFDF. Otherwise an error message is generated.

Approved label – FP (Label type 0102A) for manufactured materials can only be printed if the material types: Z010, Z020, Z030, Z040, ZAPI, ZBUL, ZRAW, ZPKB, ZPKS. Otherwise an error message is generated.

While printing Approved label, the value of Batch Characteristic-Country must be retrieved in Remark/Comment.

Rejected label – FP (Label type 0103A) for manufactured materials can only be printed if the material types are: Z010, Z020, Z030, Z040, ZAPI, ZBUL, ZRAW, ZPKB, and ZPKS. Otherwise an error message is generated

Stability Samples Label (label type 0204) can only be printed if Sample category is “Sample for Storage Condition” (QPRS-PRTYP = 6) and for all material types. Otherwise an error message is generated.

Reserve sample label (label type 0203*) can only be printed if the Sample category is Reserve sample (QPRS-PRTYP = 3) and for all material types. Otherwise an error message is generated.

Print programs will be created. New custom developed transaction will be created.

Data for label print will be stored in customer specific table to make re-print, error handling and label history report possible

Additional data required for label print can be entered manually by the user in the Z- transaction. Z-transaction must be created following the COMPANY Development Standards and naming conventions. (ZIN_QCLABEL)

A z-table (ZIN_LABELMIC) will be maintained to hold the MIC details. The MIC number is to be mentioned for ASSAY and WATER, plant wise and material wise. This details will be retrieved while printing the Approved Label – RM (0102A)

A z-table (ZIN_LABELERROR) will be maintained to hold the Error Handling (Plant, Label Type, UD Codes, Error)

A z-table (ZIN_LABELMTRTYP) will be maintained to hold the Material Type wise label printing allowed (Plant, Material Type, Label Type)

Use transaction ZIN_LABEL_HIST for Label history. Also this transaction is activated from the transaction for printing the labels (ZIN_QCLABEL). The selection screen for transaction ZIN_LABEL_HIST must contain as selection parameters the following:

Plant

Label type

Inspection lot

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Material document

Item

Material document year

Print Date

History report will show these columns:PlantLabel typeInspection LotPrint DatePrint TimeMaterialMaterial DescriptionBatchVendorVendor DescriptionVendor BatchSLED/BBDInspection DateMaterial documentMaterial document ItemMaterial document YearUser NameNo of ContainersNumber of Labels to printPrinted no of labelsQuantity per one containerPhysical sample numberComment for re-print of label

OutputAll Labels will be printed using Zebra / Intermec Printers.

The layout for labels is as follows:Size (Height): 2 InchSize (Length): 4 InchStatic Text Font: ArialStatic Text Font Size: 8Dynamic Text Font: Arial - BoldDynamic Text Font Size: 8

2.8 Label Content Matrix

The content will be printed on the label as mentioned in the table below:

Input / Label Type

Sam

ple

d-

RM

Sam

ple

d-

FP

Re

serv

e S

amp

le-

Re

serv

e S

amp

le-

Sta

bili

ty

Sam

ple

Ap

pro

ved

-RM

Re

ject

ed-

RM

Ap

pro

ved

-FP

Re

wo

rk

Re

ject

ed-

FP

 *Y-Print Content 02

01

0202

0203

A

0203

B

0204

0102

A

0103

A

0102

B

0102

C

0103

B

Material Code Y Y Y Y Y Y Y Y Y YMaterial Description

Y Y Y Y Y Y Y Y Y Y

Inspection Lot Y Y Y Y Y Y Y Y Y Y

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No.Manufacturer N/A N/A N/A N/A N/A Y Y N/A N/A N/A

Goods Receipt No

Y N/A Y N/A N/A Y Y N/A N/A N/A

Vendor Batch No.

Y N/A Y N/A N/A Y Y N/A N/A N/A

Batch No. Y Y Y Y Y Y Y Y Y YPhysical Sample No.

Y Y y Y N/A N/A N/A N/A N/A N/A

Container No. Y N/A N/A N/A N/A N/A N/A N/A N/A N/A

Storage Condition

N/A N/A N/A N/A Y N/A N/A N/A N/A N/A

Stability Start Date

N/A N/A N/A N/A Y N/A N/A N/A N/A N/A

Time Point N/A N/A N/A N/A Y N/A N/A N/A N/A N/A

Assay N/A N/A N/A N/A N/A Y N/A N/A N/A N/A

Water N/A N/A N/A N/A N/A Y N/A N/A N/A N/A

Manufacturing Date

N/A Y Y Y Y N/A N/A Y Y Y

Next Inspection Date

N/A N/A Y y N/A Y N/A N/A N/A N/A

Expiry Date N/A Y Y Y N/A Y N/A Y N/A Y

Batch Status Description

N/A N/A N/A N/A N/A Y Y Y Y Y

Remarks Y Y Y Y Y Y Y Y YUser Id Y Y Y Y Y Y Y Y Y YPrint Date Y Y Y Y Y Y Y Y Y YUD Date Y Y Y Y Y

2.9 Content Description

Length Content Description / Comments / Format

9 Material Code QALS-MATNR40 Material Description QALS-KTEXTMAT12 Inspection Lot No. QALS-PRUEFLOS10 Goods Receipt No QALS-MBLNR15 Vendor Batch No. QALS-LICHN10 Batch No. QALS-CHARG12 Physical Sample No. QPRS-PHYNR4 Container No. QALS-ANZGEB

20 Storage Condition QALS- KTEXTLOS10 Stability Start Date QALS- PASTRTERM20 Time Point QALS- KTEXTLOS5 Assay From ZIN_MIC-ASSAY5 Water From ZIN_MIC-WATER

10 Manufacturing Date MCHA-HSDAT40 Manufacturer DESCR-PRODUCER10 Next Inspection Date MCHA-QNDAT10 Expiry Date MCHA-VFDAT

40Batch Status Description

UD Code Description QGRES-CODEVE

40 Remarks Optional Remark from Input ScreenUser Id Name of Person who print Label

10 Print Date Label Printing Date

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10 UD Date QAVE-VDATUM

2.10 Label Layouts

0201-Sampled (RM)

0202-Sampled (FP)

0203A-Reserve Sample (RM)

0203B-Reserve Sample (FP)

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S A M P L E D

Material No. Description

I.Lot No.Batch No.

Vendor B.No.ContainerSample No.RemarkUser Id/Date

999999999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

999999999 A0A0A0A0A0 GR No. 9999999999

A0A0A0A0A0A0A0A9999 / 9999999999999999XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX - 99-MMM-9999

S A M P L E D

Material No. Description

I.Lot No.Batch NoMfg. DateExpiry Date

Sample No.RemarkUser Id/Date

999999999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

999999999 A0A0A0A0A099-MMM-999999-MMM-9999

999999999999XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX - 99-MMM-9999

R E S E R V EMaterial No. Description

I.Lot No.Batch No.Mfg. Date Expiry DateVendor B.No.

Sample No.RemarkUser Id/Date

999999999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

999999999 A0A0A0A0A0 GR No. 999999999999-MMM-9999 99-MMM-9999 A0A0A0A0A0A0A0A

999999999999XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX - 99-MMM-9999

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0204-Stability Sample

0102A-Approved (RM)

0102B-Approved (FP)

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R E S E R V E

Material No. Description

I.Lot No.Batch No.Mfg. DateExpiry Date

Sample No.RemarkUser Id/Date

999999999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

999999999 A0A0A0A0A099-MMM-999999-MMM-9999

999999999999XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX - 99-MMM-9999

S T A B I L I T Y

Material No. Description

I.Lot No.Batch No

Storage Cond.Time Point Stab. Start Dt.

RemarkUser Id/Date

999999999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

999999999 A0A0A0A0A0 XXXXXXXXXXXXXXXXXXXXAOAOAOAOAO 99-MMM-9999

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX - 99-MMM-9999

A P P R O V E D

Material No. Description Manufacturer I.Lot No.Batch No.Mfg. Date Expiry DateVendor B.No.Batch StatusUD Date RemarkUser Id/Date

999999999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 999999999 A0A0A0A0A0 GR No 9999999999 99-MMM-9999 Retest Date 99-MMM-999999-MMM-9999 Assay 99.99% A0A0A0A0A0A0A0A Water 99.99%XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX99-MMM-9999XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX - 99-MMM-9999

A P P R O V E D

Material No. Description

I.Lot No.Batch NoMfg. DateExpiry Date

Batch StatusUD Date RemarkUser Id/Date

999999999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

999999999 A0A0A0A0A099-MMM-9999 Retest Date 99-MMM-999999-MMM-9999

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX99-MMM-9999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX - 99-MMM-9999

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0103A-Rejected (RM)

0103B-Rejected (FP)

0102C – Rework

2.11 Label Fields

Field Label Material No.Start position Line 01

Column 1Font Arial / Bold

8Align left

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R E J E C T E D

Material No. Description ManufacturerI.Lot No.Batch No.

Vendor B.No.Batch StatusUD Date RemarkUser Id/Date

999999999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX999999999 A0A0A0A0A0 GR No. 9999999999

A0A0A0A0A0A0A0AXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX99-MMM-9999XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX - 99-MMM-9999

R E J E C T E D

Material No. Description

I.Lot No.Batch No.Mfg. DateExpiry Date

Batch StatusUD Date RemarkUser Id/Date

999999999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

999999999 A0A0A0A0A099-MMM-999999-MMM-9999

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX99-MMM-9999XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX - 99-MMM-9999

R EW

OR

KMaterial No. Description

I.Lot No.Batch NoMfg. Date

Batch StatusUD Date RemarkUser Id/Date

999999999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

999999999 A0A0A0A0A099-MMM-9999 Retest Date 99-MMM-9999

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX99-MMM-9999 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX - 99-MMM-9999

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Applicability MandatoryPrinted AlwaysField descriptionStart position Line 01

Tab stop left: 0.75 inchLength 9Font Arial

8Align left

Example Material No: 123456789

Source QALS-MATNRComment N/A

Field Label DescriptionStart position Line 02

Column 1Font Arial / Bold

8Align left

Applicability MandatoryPrinted AlwaysField descriptionStart position Line 02

Tab stop left: 0.75 inchLength 40Font Arial

8Align left

Example Description: AMOXICILLIN TRIHYDRATE FCT 7500 MG BL 10

Source QALS-KTEXTMATComment N/A

Field Label ManufacturerStart position Line 03

Column 1Font Arial / Bold

8Align left

Applicability Mandatory for Label Type 0102A, 0103APrinted When label Type is 0102A, 0103AField descriptionStart position Line 03

Tab stop left: 0.75 inchLength 40Font Arial

8Align left

Example Description: XYX CHEMICALS LTD

Source DESCR-PRODUCERComment N/A

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Field Label I.Lot No.Start position Line 04

Column 1Font Arial / Bold

8Align left

Applicability MandatoryPrinted AlwaysField descriptionStart position Line 04

Tab stop left: 0.75 inchLength 12Font Arial

8Align left

Example Description: 10000000056

Source QALS-PRUEFLOSComment N/A

Field Label Batch No.Start position Line 05

Column 1Font Arial / Bold

8Align left

Applicability MandatoryPrinted AlwaysField descriptionStart position Line 05

Tab stop left: 0.75 inchLength 10Font Arial

8Align left

Example Description: 0000031234 / A123456

Source QALS-CHARGComment N/A

Field Label GR No.Start position Line 05

Tab stop left: 1.8 inchFont Arial / Bold

8Align left

Applicability Mandatory for Label Type: 0201, 0203A, 0102A, 0103A

Printed When Label Type is Label Type: 0201, 0203A, 0102A, 0103A

Field descriptionStart position Line 05

Tab stop left: 2.6 inch

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Length 10Font Arial

8Align left

Example GR No.: 4512345678

Source QALS- MBLNRComment N/A

Field Label Mfg. DateStart position Line 6

Column 1Font Arial / Bold

8Align left

Applicability Manufacturing Date of Material Mandatory for Label Type: 0203A, 0203B, 0103B, 0202, 0102A, 0102B, 0102C

Printed When Label Type is 0203A, 0203B, 0103B, 0202, 0102A, 0102B, 0102C

Field descriptionStart position Line 6

Tab stop left: 0.75 inchLength 11Font Arial

8Align left

Example Mfg. Date: 31-DEC-2010

Source MCHA-HSDATComment N/A

Field Label Expiry DateStart position Line 7

Column 1Font Arial / Bold

8Align left

Applicability Expiry Date of Material Mandatory for Label Type: 0203A, 0203B, 0103B, 0202, 0102A, 0102B, 0102C

Printed When Label Type is 0203A, 0203B, 0103B, 0202, 0102A, 0102B, 0102C

Field descriptionStart position Line 7

Tab stop left: 0.75 inchLength 11Font Arial

8Align left

Example Expiry Date: 31-DEC-2010

Source MCHA-VFDATComment N/A

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Field Label Retest DateStart position Line 6

Tab stop left: 1.8 inchFont Arial / Bold

8Align left

Applicability Expiry Date of Material Mandatory for Label Type: 0102A, 0102B, 0102C

Printed When Label Type is 0102A, 0102B, 0102CField descriptionStart position Line 6

Tab stop left: 2.6 inchLength 11Font Arial

8Align left

Example Retest Date: 31-DEC-2010

Source MCHA-QNDATComment N/A

Field Label Vendor B.No.Start position Line 08

Column 1Font Arial / Bold

8Align left

Applicability Mandatory for Label Type: 0201, 0203A, 0102A, 0103A

Printed When Label Type is Label Type: 0201, 0203A, 0102A, 0103A

Field descriptionStart position Line 08

Tab stop left: 0.75 inchLength 15Font Arial

8Align left

Example Vendor B.No.: 123456789012345

Source QALS-LICHNComment N/A

Field Label ContainerStart position Line 9

Column 1Font Arial / Bold

8Align left

Applicability Mandatory for Label Type: 0201Printed When Label Type is 0201Field descriptionStart position Line 9

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Tab stop left: 0.75 inchLength 11Font Arial

8Align left

Example Container: 9999 / 9999

Source from Input Screen / QALS-ANZGEB (x/n)Comment N/A

Field Label AssayStart position Line 7

Tab stop left: 1.8 inchFont Arial / Bold

8Align left

Applicability Mandatory for Label Type: 0102APrinted When Label Type is 0102A and Material

Type is ZRAW (Raw Material)Field descriptionStart position Line 7

Tab stop left: 2.6 inchLength 8Font Arial

8Align left

Example Assay: 99.99 %

Source ZIN_MIC, QAMRComment Select Plant from QALS

Select Group Counter from QALS Select ASSAY MIC Number from ZIN_MICFetch Value from QAMR

Field Label WaterStart position Line 7

Tab stop left: 1.8 inchFont Arial / Bold

8Align left

Applicability Mandatory for Label Type: 0102APrinted When Label Type is 0102A and Material

Type is ZRAW (Raw Material)Field descriptionStart position Line 7

Tab stop left: 2.6 inchLength 8Font Arial

8Align left

Example Water: 99.99 %

Source ZIN_MIC, QAMRComment Select Plant from QALS

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Doc. ID.: xxx/yyyVersion: 1.0

Select Group Counter from QALS Select WATER MIC Number from ZIN_MICFetch Value from QAMR

Field Label Storage Cond.Start position Line 7

Column 1Font Arial / Bold

8Align left

Applicability Mandatory for Label Type: 0204Printed When Label Type is 0204Field descriptionStart position Line 7

Tab stop left: 0.75 inchLength 15Font Arial

8Align left

Example Storage Cond.:AAAAAAAAAAAAAAA

Source QALS- KTEXTLOSComment N/A

Field Label Time PointStart position Line 8

Column 1Font Arial / Bold

8Align left

Applicability Mandatory for Label Type: 0204Printed When Label Type is 0204Field descriptionStart position Line 8

Tab stop left: 0.75 inchLength 10Font Arial

8Align left

Example Time Point : AAAAAAAAAA

Source QALS- KTEXTLOSComment N/A

Field Label Stab. Start Dt.Start position Line 9

Column 1Font Arial / Bold

8Align left

Applicability Mandatory for Label Type: 0204Printed When Label Type is 0204

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Field descriptionStart position Line 9

Tab stop left: 0.75 inchLength 11Font Arial

8Align left

Example Stab. Start Dt.: 31-DEC-2010

Source QALS- PASTRTERMComment N/A

Field Label Batch StatusStart position Line 9

Column 1Font Arial / Bold

8Align left

Applicability UD – Batch Status of Material Mandatory for Label Type: 0102A, 0102B, 0102C, 0103A, 0103B

Printed When Label Type is 0102A, 0102B, 0102C, 0103A, 0103B

Field descriptionStart position Line 9

Tab stop left: 0.75 inchLength 40Font Arial

8Align left

Example Batch Status: APPROVED, NOT FOR COMMERCIAL PURPOSE

Source QGRES-CODEVEComment N/A

Field Label UD DateStart position Line 10

Column 1Font Arial / Bold

8Align left

Applicability UD Date of Material Mandatory for Label Type: 0102A, 0102B, 0102C, 0103A, 0103B

Printed When Label Type is 0102A, 0102B, 0102C, 0103A, 0103B

Field descriptionStart position Line 10

Tab stop left: 0.75 inchLength 11Font Arial

8Align left

Example UD Date: 31-DEC-2010

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Source QAVE-VDATUMComment N/A

Field Label Sample No.Start position Line 10

Tab stop left: 1.8 inchFont Arial / Bold

8Align left

Applicability Mandatory for Label Type: 0201, 0202, 0203A, 0203B

Printed When Label Type is Label Type: 0201, 0202, 0203A, 0203B

Field descriptionStart position Line 10

Tab stop left: 2.6 inchLength 12Font Arial

8Align left

Example Sample No.: 451234567890

Source QPRS-PHYNRComment N/A

Field Label RemarksStart position Line 11

Column 1Font Arial / Bold

8Align left

Applicability It will be used as free text.However, for 0102A, default vale will be set with the Country (from Batch Characteristic).

Printed AlwaysField descriptionStart position Line 11

Tab stop left: 0.75 inchLength 40Font Arial

8Align left

Example Remark: Reprint due to Electricity Failure

Source From Data Selection ScreenComment N/A

Field Label User Id/DateStart position Line 12

Column 1Font Arial / Bold

8

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Align leftApplicability User-ID of person who prints the label and

Date of PrintingPrinted AlwaysField descriptionStart position Line 12

Tab stop left: 0.75 inchLength 10 + 1 + 11Font Arial

8Align left

Example User Id/Date: QCEXEC0001 – 31-DEC-2010

Source From Data Selection ScreenComment N/A

Additional functions The user will have the option to reprint the labels display and print label history report select certain object to print labels add necessary data on labels

If mandatory fields are missing, labels will not be printed. User has to correct missing or wrong data (master data, documents) to proceed to print the labels using Z- transaction.

Re-print could be done in the same Z- transaction.

Special printing options

The printer should be selected/change from the list of printers.

Performance aspectsN/A

AuthorizationsLabel type and Plant will be used as authorisation objects. Job roles should be defined for different label type and plant combinations.

DependenciesN/A

3 Further information

Contact persons / Function

Technical Expert : Mayank Mevcha

References

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