Stability Study in Sap Qm

(1)

ERP 6.0

September 2012

Pharma: Stability Study in

Quality Management (P65)

SAP AG Dietmar-Hopp-Allee 16 69190 Walldorf Germany

(2)

Copyright

No part of this publication may be reproduced or transmitted in any form or for any purpose without the express permission of SAP AG. The information contained herein may be changed without prior notice.

Some software products marketed by SAP AG and its distributors contain proprietary software components of other software vendors.

Microsoft, Windows, Excel, Outlook, PowerPoint, Silverlight, and Visual Studio are registered trademarks of Microsoft Corporation.

IBM, DB2, DB2 Universal Database, System i, System i5, System p, System p5, System x, System z, System z10, z10, z/VM, z/OS, OS/390, zEnterprise, PowerVM, Power Architecture, Power Systems, POWER7, POWER6+, POWER6, POWER, PowerHA, pureScale, PowerPC, BladeCenter, System Storage, Storwize, XIV, GPFS, HACMP, RETAIN, DB2 Connect, RACF, Redbooks, OS/2, AIX, Intelligent Miner, WebSphere, Tivoli, Informix, and Smarter Planet are trademarks or registered trademarks of IBM Corporation.

Linux is the registered trademark of Linus Torvalds in the United States and other countries.

Adobe, the Adobe logo, Acrobat, PostScript, and Reader are trademarks or registered trademarks of Adobe Systems Incorporated in the United States and other countries.

Oracle and Java are registered trademarks of Oracle and its affiliates.

UNIX, X/Open, OSF/1, and Motif are registered trademarks of the Open Group.

Citrix, ICA, Program Neighborhood, MetaFrame, WinFrame, VideoFrame, and MultiWin are trademarks or registered trademarks of Citrix Systems Inc.

HTML, XML, XHTML, and W3C are trademarks or registered trademarks of W3C®, World Wide Web Consortium, Massachusetts Institute of Technology.

Apple, App Store, iBooks, iPad, iPhone, iPhoto, iPod, iTunes, Multi-Touch, Objective-C, Retina, Safari, Siri, and Xcode are trademarks or registered trademarks of Apple Inc.

IOS is a registered trademark of Cisco Systems Inc.

RIM, BlackBerry, BBM, BlackBerry Curve, BlackBerry Bold, BlackBerry Pearl, BlackBerry Torch, BlackBerry Storm, BlackBerry Storm2, BlackBerry PlayBook, and BlackBerry App World are trademarks or registered trademarks of Research in Motion Limited.

Google App Engine, Google Apps, Google Checkout, Google Data API, Google Maps, Google Mobile Ads, Google Mobile Updater, Google Mobile, Google Store, Google Sync, Google Updater, Google Voice, Google Mail, Gmail, YouTube, Dalvik and Android are trademarks or registered trademarks of Google Inc.

INTERMEC is a registered trademark of Intermec Technologies Corporation. Wi-Fi is a registered trademark of Wi-Fi Alliance.

Bluetooth is a registered trademark of Bluetooth SIG Inc.

Motorola is a registered trademark of Motorola Trademark Holdings LLC. Computop is a registered trademark of Computop Wirtschaftsinformatik GmbH.

SAP, R/3, SAP NetWeaver, Duet, PartnerEdge, ByDesign, SAP BusinessObjects Explorer, StreamWork, SAP HANA, and other SAP products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of SAP AG in Germany and other countries.

(3)

Business Objects and the Business Objects logo, BusinessObjects, Crystal Reports, Crystal Decisions, Web Intelligence, Xcelsius, and other Business Objects products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of Business Objects Software Ltd. Business Objects is an SAP company.

Sybase and Adaptive Server, iAnywhere, Sybase 365, SQL Anywhere, and other Sybase products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of Sybase Inc. Sybase is an SAP company.

Crossgate, m@gic EDDY, B2B 360°, and B2B 360° Services are registered trademarks of Crossgate AG in Germany and other countries. Crossgate is an SAP company.

All other product and service names mentioned are the trademarks of their respective companies. Data contained in this document serves informational purposes only. National product specifications may vary. These materials are subject to change without notice. These materials are provided by SAP AG and its affiliated companies ("SAP Group") for informational purposes only, without representation or warranty of any kind, and SAP Group shall not be liable for errors or omissions with respect to the materials. The only warranties for SAP Group products and services are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing herein should be construed as constituting an additional warranty.

(4)

Icons

Icon Meaning Caution Example Note Recommendation Syntax

Typographic Conventions

Type Style Description

Example text Words or characters that appear on the screen. These include field names,

screen titles, pushbuttons as well as menu names, paths and options. Cross-references to other documentation.

Example

text Emphasized words or phrases in body text, titles of graphics and tables.

EXAMPLE

TEXT Names of elements in the system. These include report names, program names, transaction codes, table names, and individual key words of a programming language, when surrounded by body text, for example, SELECT and INCLUDE.

Example

text Screen output. This includes file and directory names and their paths, messages, source code, names of variables and parameters as well as names of installation, upgrade and database tools.

EXAMPLE TEXT_{Keys on the keyboard, for example, function keys (such as}_F2_{) or the}_ENTER_key.

Example

text Exact user entry. These are words or characters that you enter in the system exactly as they appear in the documentation.

<Example

(5)

Stability Studies in Quality Management (P65)

1 Purpose

Stability studies or shelf-life studies are conducted to track and examine how different environmental conditions (such as temperature, brightness, or moisture) affect a compound, a material, or a batch over a specified period of time. For this purpose, you create physical samples of the material or batch and store them under controlled conditions for the duration of the study. At specified intervals during the study, you remove these physical samples or parts of these samples from the various conditions and test them according to predefined inspection plans.

The test results from the study can be used, for example, to confirm if the desired or guaranteed life expectancy of the product conforms to predefined recommendations for storage.

The overall stability study process is made up of the following subordinate process stages:

The process steps described below depict a typical process sequence. Because the stability study is a solution that can be flexibly adapted to meet the needs of different users, other process sequences that differ from the one described below are also possible.

1. Initiating the Stability Study

To initiate the stability study, create a quality notification (type QS or QR, depending on whether or not you are conducting a study about a material).

Perform the following additional activities in any desired sequence:

o Create a physical-sample record for the initial sample to be delivered to your laboratory. *

o Assign a stability bill-of-material to the stability study (only if the study is being conducted regarding a material). *

o Confirm the receipt of the initial sample when it arrives in your laboratory. *

Many of the process steps in the stability study are performed using follow-up functions in the action box of the quality notification or stability study. In the process description, all steps that are triggered by follow-up functions are marked with an asterisk (*).

2. Initial Testing

Test the initial sample. Depending on the results of this test, decide if you want to continue the stability study. During the initial test, perform the following activities:

o Create an inspection lot for the initial sample. *

o Perform the initial test by inspecting the initial sample and recording your test results.

o Complete the initial test by making the usage decision for the inspection lot. 3. Stability Planning

If you decide to continue the stability study based on the results of the initial test, you begin planning the extended series of stability tests.

(7)

If necessary, you can begin the stability planning activities during the initial testing phase.

In the stability planning phase, perform the following activities:

o Specify the storage conditions under which the stability samples is stored in this stability study. *

o Create a testing schedule to plan the scope and frequency of the stability tests. * o Create separate inspection plans for each storage condition.

o Process the testing schedule to assign the inspection plans to the respective storage conditions. *

o Complete the testing schedule. *

o Print the storage list. The system automatically calculates the quantities needed for the stability samples and prints these quantities on the storage list.

o Maintain the storage data for the stability samples in the system. *

o Physically create the stability samples, print and affix the physical-sample labels, and place the samples in storage under the predefined storage conditions. o Define a start date for the stability study.

The system automatically calculates all test dates for the duration of the study. * 4. Stability Testing

You perform the stability tests.

This process phase may last several weeks or months, or as much as several years. During this phase, you perform the following activities:

o Monitor the testing dates. If necessary, you can influence the test dates (for

example, by creating additional test dates, skipping certain test dates, restarting the scheduling process, and so on).

o Schedule a background job that periodically creates the inspection lots on the scheduled testing dates. You can flexibly create a work list of inspection lots in advance by specifying a lead time before the test dates.

o Remove the stability samples from storage on the specified test dates and perform the stability tests. Following each test, you return each stability sample to storage. o Analyze the stability study process by performing evaluations.

5. Completing the Stability Study

Once all planned stability tests have been performed, you complete the stability study.

You do not have to complete the stability study as you originally planned at the beginning of the study. If necessary, you can:

 Cancel the stability study for all storage conditions or for selected storage conditions at any time *

 Deactivate the stability study for all storage conditions or for selected storage conditions, for an indefinite period of time (for example, if you want to resume testing at a later date) *

(8)

In this scenario the material PH-6601 - TuSAPin (100 ml) is subject of stability studies.

2 Prerequisites

2.1 Master Data and Organizational Data

Default Values

The organizational structure and master data of your company was created in your ERP system during implementation. The organizational structure reflects the structure of your company. The master data represents materials, customers, and vendors, for example, depending on the operational focus of your company

The business process is enabled with this organization-specific master data, examples are provided in the next section.

Additional Default Values

You can test the scenario with other SAP Best Practices default values that have the same characteristics.

Check your SAP ECC system to find out which other material master data exists.

Using Your Own Master Data

You can also use customized values for any material or organizational data for which you have created master data. For more information on how to create master data, see the Master Data Procedures documentation.

Use the following master data in the process steps described in this document:

Manufacturing / Trade

Production Plant

Master / Org. Data Value Master / Org. Data Details Comments

Material PH-6601 TuSAPin (100 ml)

Plant 1000 Plant1

2.2 Business Conditions

The business process described in this Business Process Documentation is part of a larger chain of The business process described in this Business Process Documentation (BPD) is part of a bigger chain of integrated business processes or scenarios. As a result, you must have completed the

(9)

following processes and fulfilled the following business conditions before you can start any activities in this scenario:

Business condition Document

Costing run must be performed Final Steps documentation

Check and change MM period to current period Final Steps documentation To execute this scenario, material PH-6601 should be

in stock with batches

To Execute this activity, run the Business Process Documentation Pharma: Liquid Dosage Finished

Product packaging with Subcontr (P53) scenario

Only relevant steps for PH-6601

Pharma: Liquid Dosage Finished Product packaging with Subcontr (p53)

2.3 Roles

Use

The following roles must have already been installed to test this scenario in the SAP NetWeaver Business Client (NWBC). The roles in this Business Process Documentation must be assigned to the user or users testing this scenario. You only need these roles if you are using the NWBC interface. You do not need these roles if you are using the standard SAP GUI.

Prerequisites

The business roles have been assigned to the user who is testing this scenario.

Business Role Technical Name Process Step

Quality Specialist SAP_NBPR_QUALMGR_S Creating Stability Study and other steps

Maintenance

Employee SAP_NBPR_MAINTENANCE_S Deadline Monitoring

(10)

3 Process Overview Table

Process Step Business

Condition Business Role Transaction Code Expected Results Initiating the Stability Study

Creating a Stability

Study Quality Specialist QST01

Creating Physical Sample Record for the Stability Study

Quality

Specialist QM02

Assigning a Stability

BOM Quality Specialist QM02

Confirm the receipt of

the Initial Sample Quality Specialist QM02

Initial Testing

Creating the Initial Test

Inspection Lot Quality Specialist QM02

Result Recording Quality

Specialist QE51N

Usage Decision Quality

Specialist QA11 (or QE51N)

Planning Stability Tests

Specifying Storage

Conditions Quality Specialist QM02

Creating the Testing

Schedule Quality Specialist QM02

Processing the Testing

Schedule Quality Specialist QM02

Completing the Testing Schedule

Quality Specialist

(11)

Process Step Business

Condition Business Role Transaction Code Expected Results

Printing the Storage

List Quality Specialist QM02

Maintaining the Storage

Data Quality Specialist QM02

Defining the Start Date

for the Stability Tests Quality Specialist QM02

Performing the Stability Tests

Deadline Monitoring Maintenance

Employee IP30

Display Stability History Quality

Specialist QM02

Goods issue of samples (CO cost center)

Warehouse

Clerk MB1A

Completing the Stability Study

Completing the Stability

(12)

4 Process Steps

4.1 Initiating the Stability Study

In this first phase of the stability study process, you create a record in the system to document your intent of conducting a stability study, and you prepare to receive and manage the physical samples to be tested.

4.1.1 Creating a Stability Study

Use

This activity creates a stability study for the material PH-6601- TuSAPin (100 ml).

Prerequisites

The required material PH-6601 must be available in stock.

Procedure

1. Call up the Create Notification transaction as follows:

Option 1: SAP Graphical User Interface (SAP GUI)

SAP ECC Menu Logistics → Quality Management → Stability Study → Stability Study

→ Create

Transaction code

QST01

Option 2: SAP NetWeaver Business Client (SAP NWBC) via business role Business role Quality Specialist

(SAP_NBPR_QUALMGR_S)

Business role menu Quality Management → Stability Study → Create Stability Study

2. On the Create Notification: Initial Screen, enter the following required data and choose

Enter:

Field name User action and

values Comment

Notification type

QS Type of the stability study

QR: Stability study without material QS: Stability Study with material

Notification PH1000 Notification number. Enter an unique identifier for the quality notification, such as PH1000

3. On the Create Notification: StabilStudy with Mat screen, enter the following required data:

Field name User action and values

Comment

Material PH-6601 Number of the material for which the stability study is processed

(13)

Plant for

mat. 1000 After choosing Enter, the Batch field becomes an input field. Batch < batch of material

PH-6601> Number of the batch used for the Stability study. 4. Save the stability study (notification).

Result

A stability study regarding material PH-6601 was created.

4.1.2 Creating Physical Sample Record for the Stability Study

Use

This activity plans the receipt of the initial sample by creating a corresponding physical sample-record in the system. When you create the sample-record for the initial sample, the system automatically:

 Sets a status in the physical-sample record indicating that the initial sample has been created

 Retrieves the following information from the stability study and proposes it for entry in the physical-sample record:

o Physical-sample type (sample for stability study) o Physical-sample category (stability sample - initial)

When the initial sample has been created, the action is documented as a task in the quality notification.

Procedure

1. Call up the Change Notification transaction as follows:

SAP Menu Logistics → Quality Management → Stability Study → Stability Study

→ Change

QM02

Business role

menu Quality Management → Quality Notifications → Change Quality Notification

2. On the Change Notification: Initial Screen, in the Notification field, enter the number of the notification from the previous step (for example, PH1000), then choose Enter.

3. In the right pane, in the Action box pane, choose the Create Initial Sample button. 4. On the Create Initial Sample dialog box, choose the And Change Notification button. 5. Choose the Tasks tab.

The Initial Sample Created task is displayed in the task list. This task is automatically created by the follow-up function for creating the initial sample.

(14)

6. Save your entries.

Result

The initial sample for the Stability Study was created.

4.1.3 Assigning a Stability BOM (Optional)

Use

This activity assigns a stability bill-of-materials (BOM) to the stability study.

This step is optional and can be performed any time after you have created the stability study. In a stability bill-of-material (BOM), you document the components, substances, or ingredients that make up the material or product to be tested, from a stability or shelf-life perspective. In a stability study for a self-produced drug, for example, the laboratory is usually more interested in the

proportion of active ingredients and chemical composition of the compound, rather than the material BOM associated the process order or production order. The stability BOM is used for documentation purposes only. In a BOM, you can also describe the compound or product using text components, which can be especially important for newly developed products.

Procedure

→ Change

QM02

Business role

2. On the Change Notification: Initial Screen, in the Notification field, enter the notification number you created previously (for example, PH1000) and choose Enter. 3. On the Change Notification: StabilStudy with Mat screen, in the right

pane, choose the Assign Bill of Material button.

4. On the Assign BOM dialog box, enter the following information:

Field name Description User action and

Material Material number PH-6601 Value proposed by the system

Plant Plant 1000 Value proposed by the system

Usage BOM Usage 8 Value proposed by the system

(15)

BOM

5. Choose the Assign Bill of Material button.

6. Choose the Tasks tab.

The BOM Assigned task is displayed in the task list. This task is automatically created by the follow-up function for assigning the stability BOM.

Result

A stability BOM was assigned to the stability study.

4.1.4 Confirm the Receipt of the Initial Sample

Use

This activity confirms the receipt of the initial sample in the laboratory for testing. To confirm the initial sample, you execute a corresponding follow-up function in the action box. The system automatically:

 Confirms the physical-sample drawing

 Changes the physical-sample record for the initial sample (a change document is created)  Releases the initial sample (a corresponding status is set in the physical-sample record) You can only confirm the receipt of the initial sample once.

Confirming the initial sample is a prerequisite for recording inspection results during the initial test. When you confirm the initial sample, the action is documented as a task in the quality notification

Procedure

→ Change

QM02

Business role

2. On the Change Notification: Initial Screen, in the Notification field, enter the notification number you created previously (for example, PH1000) and choose Enter.

3. On the Change Notification: StabilStudy with Mat screen, in the right pane, choose the Confirm

Initial Sample button.

4. On the Confirm Initial Sample dialog box, enter the following information:

(16)

values

Primary

Packing <Primary Packing Material>

YP-01 Define the primary packing material.

Sample

Quantity 100 EA Sample quantity for the stability study

5. Choose the And Change Notification button.

6. On the Additional Data for Phys.-Sample Drawing Confirmation dialog box, enter a comment if desired and choose Continue.

7. Choose the Tasks tab.

The Initial Sample Confirmed task is displayed in the task list. This task was automatically created by the follow-up function for confirming the initial sample.

Result

The receipt of the initial sample for the stability study was confirmed. After this process step the initial testing can be processed.

4.2 Initial Testing

Use

The initial testing phase inspects the initial sample. Based on the results of the initial test, you then decide whether or not to continue the stability study. The initial test ensures that the initial sample and subsequent stability samples (which may be created from quantity of initial sample) meet your specific requirements for the stability study, before you proceed with the actual stability testing phase.

4.2.1 Creating the Initial Test Inspection Lot

This procedure describes how you can manually create an inspection lot for the initial sample to perform the initial test.

Procedure

→ Change

Transaction

code QM02

Business role

(17)

2. On the Change Notification: Initial Screen, in the Notification field, enter the notification number you created previously (for example, PH1000) and choose Enter.

3. On the Change Notification: StabilStudy with Mat screen, in the right pane, choose the Initial

Test Inspection Lot button.

4. On the Selection of Inspection Specifications dialog box, enter the following required values:

Field name Description User action

and values Comment

Inspection Type

YP1601

Group <Task List Group of the Inspection Plan used for the initial inspection>

IPP-017

Group

Counter <Group Counter> 1

5. Choose the Create Inspection Lot button.

6. On the Flexible Selection and Changing of Specifications dialog box, choose Copy All. All specifications defined in the inspection plan are transferred to the inspection lot.

7. Choose the Tasks tab. The Inspection Lot for Initial Test Created task is displayed in the task list. This task was automatically created by the follow-up function for creating the inspection lot. 8. Save your entries.

Result

The inspection lot for the initial testing was created.

4.2.2 Result Recording

Use

This activity performs the initial test by inspecting the initial sample and recording your test results.

Procedure

For more information, see the standard ECC documentation on this point. 1. Call up the Worklist: Results Recording transaction as follows:

SAP ECC Menu Logistics → Quality Management → Quality Inspection → Worklist → Results Recording

QE51N

Option 2: SAP NetWeaver Business Client (SAP NWBC) via business role Business Role Quality Specialist

Business Role

Menu Quality Management → Quality Inspection → Inspection Results → Results Recording Worklist

(18)

Field name Description User action and

Plant Plant 1000

Insp.lot

origin Inspection Lot Origin 16 (Stability Studies)

Material Material number PH-6601

3. Choose Execute (F8).

4. The selected inspection lots are displayed on the left of the screen. 5. The first operation 0010 within the Inspection lot is automatically selected. 6. Note the Inspection Lot number here:______________________

7. Enter Sampling Location: 01 and choose enter

8. On the Record Results: Characteristics Overview screen, record the following results for the following characteristics for the first sampling location in operation 0010:

Field

name Description User action and values Comment

Inspected Number of inspected

sample 1 For Description

Results Result for characteristic Description

01 For Description

sample 1 For pH-Value

Results Result for characteristic

pH-Value between 5.2 .. 7.5 For pH-Value

sample 1 For Each by-product

Each by-product <= 1.0 For Each by-product

Inspected Number of inspected sample

1 For All

by-products Results Result for characteristic All

by-products <= 5.0 For All by-products

sample 1 For Loss on drying

Results Result for characteristic Loss on drying

<= 8.0 For Loss on

drying 9. Select your characteristics and choose valuate. Choose Close.

10. Choose Save.

11. On the Record Results Worklist screen, choose operation 0020 12. Enter Sampling Location: 01 and choose enter

13. On the Record Results: Characteristics Overview screen, record the following results for the characteristics for the first sampling location in operation 0020:

(19)

Field name Description User action and

Inspected Number of inspected sample 1 For Content

Content between 95.0 .. 105.0 For Content

14. Select your characteristics and choose valuate. Choose Close. 15. Choose Save.

16. On the Record Results Worklist screen, choose operation 0030 17. Enter Sampling Location: 01 and choose enter

18. On the Record Results: Characteristics Overview screen, record the following results for the characteristics for the first sampling location in operation 0030:

Field

name Description User action and values Comment

Inspected Number of inspected sample 1 For Sterility

Results Result for characteristic Sterility

01 For Sterility

Inspected Number of inspected sample 1 For Bact.

endotoxins Results Result for characteristic Bact.

endotoxins <= 3.5 EU/ml For Bact. endotoxins 19. Select your characteristics and choose valuate. Choose Close.

20. Choose Save.

Result

The inspection lot for the initial testing has been processed. The results for the inspection lot have been saved. The usage decision can now be made.

4.2.3 Usage Decision

Use

You complete the initial test by making the usage decision for the inspection lot. This usage decision determines whether or not the stability study is continued. When you make the usage decision, you can choose between the following usage decision codes:

 Complete initial test: Stability study is continued

If you choose and save this usage decision, the system automatically executes a follow-up action that sets the user status Initial Test Completed in the stability study.

 Complete initial test: Stability study is not continued

If you choose and save this usage decision, the system also executes a follow-up action automatically that sets the user status Initial Test Completed in the stability study.

(20)

have saved the usage decision. In this way, you can manually trigger additional follow-up functions in the action box (for example, to cancel or complete the stability study, to print lists, and so on).

Procedure

1. Call up the Usage Decision transaction as follows:

SAP ECC Menu Logistics → Quality Management → Stability Study → Stability Test → Usage Decision → Record

QA11

Option 2: SAP NetWeaver Business Client (SAP NWBC) via business role Business Role Quality Specialist

Business Role

Menu Quality Management → Quality Inspection → Inspection Lot → Record Usage Decision

2. On the Record Usage Decision screen, in the Inspection Lot field, enter the inspection lot number (or choose F4 to search for it) and choose Enter.

3. On the Record Usage Decision: Characteristic Overview screen, in the UD Code field, enter 01 and choose Enter.

5. The system displays an information dialog box stating that the operation was successfully performed. Choose Continue.

4.3 Planning Stability Tests

Use

This activity plans the stability tests, physically create the stability samples, place the stability samples into storage, and define a start date for the stability study.

4.3.1 Specifying Storage Conditions

During a stability study, you examine what effects individual storage conditions have on specific characteristics of a product over an extended period of time (for example, in terms of shelf life or potency). When you specify the storage conditions during the stability planning phase, you can only choose storage conditions that have previously been defined in Customizing.

To prepare for the stability tests, select the storage conditions under which you intend to store and test the stability samples. In this procedure, you select these storage conditions and assign them to the stability study.

Prerequisites

Storage conditions are defined in Customizing.

(21)

→ Change

QM02

Business role menu

Quality Management → Quality Notifications → Change Quality Notification

2. On the Change Notification: Initial Screen, in the Notification field, enter the previously created notification number (for example, PH1000), then choose Enter.

3. On the Change Notification: StabilStudy with Mat screen, choose the Specify Storage

Conditions button on the right pane.

4. On the Define Stability Samples (Storage Conditions) dialog box, in the Selection Storage Cond.

For Study section, make the following entries:

Stor.Cond. Quantity

YP000001 1 EA

YP000002 1 EA

YP000003 1 EA

The quantity you enter for a storage condition is multiplied by the number of planned tests for the storage condition when you print the storage list, to calculate a proposal for the sample quantity to be stored. Enter a default quantity for the storage condition that is needed to test the storage condition exactly once.

5. Select the rows and choose the And Change Notification button. 6. Choose the Tasks tab.

The Storage Conditions Specified task is displayed in the task list. This task is automatically created by the follow-up function for specifying the Storage Conditions.

Result

The Storage Conditions for the stability study and the sample quantity for each Storage Condition have been specified. The system has saved the selected storage conditions in the Stability Study and has automatically created a sample record for each storage condition. Each physical-sample record identifies the physical physical-sample that are later stored under the respective storage condition.

4.3.2 Creating the Testing Schedule

Use

(22)

The testing schedule specifies:

 What is tested (storage conditions)

 When the stability tests take place (testing dates)  How the tests are performed (which inspection plans)

When you create the testing schedule, the system creates the testing schedule header and a testing schedule item for each storage condition you specified in the stability study. In doing so, the system automatically uses the storage condition short text as the short text for the testing schedule item.

Prerequisites

A strategy has been defined. A strategy defines the rules for the sequence of planned stability inspections. The strategy QSTABI, which is provided as an example in the standard system, is used for this scenario.

Procedure

→ Change

QM02

Business role

3. On the Change Notification: StabilStudy with Mat screen, choose the Create Testing Schedule button on the right pane.

4. On the Create Testing Schedule dialog box, enter the following data:

Field name Description User action and values

Comment

Maintenance

Plan Select the needed storage conditions

PH1000

(The system

proposes the key for the stability study as the key for the testing schedule)

The testing schedule is a special type of maintenance plan. Maint. Plan cat. Maintenance plan category ST (suggested by the system)

In the standard system, the maintenance plan category ST is provided for stability studies

(23)

Maintenance

strategy Maintenance strategy QSTABI The assignment of the strategy to the header simply informs the system which intervals are available for use in this particular testing schedule.

Scheduling

period Scheduling period

60 MON Planned duration of the stability study

Inspection Type

Inspection Type YP1601 Inspection type for the inspection lots created during the stability study

6. Choose the Tasks tab. The Testing Schedule created task is displayed in the task list. This task was automatically created by the follow-up function for creating the testing schedule.

Result

The testing schedule for the stability study has been created. The system automatically creates an item in the testing schedule for each storage condition in the stability study. The object entered for a testing schedule item is the physical sample that is associated with the storage condition in this stability study.

4.3.3 Processing the Testing Schedule

Use

This activity assigns an inspection plan to each storage condition or item in the testing schedule.

Prerequisites

Inspection plans for the different storage conditions have been created. The following inspection plans are delivered with SAP Best Practices for Pharmaceuticals.

Procedure

→ Change

QM02

Business role

(24)

3. On the Change Notification: StabilStudy with Mat screen, choose the Change Testing Schedule button on the right pane.

4. On the Edit Testing Schedule for Stability Study dialog box, choose Yes.

5. The Testing Schedule (Maintenance Plan) is displayed. In the item overview an item for each storage condition is displayed.

6. Select the first row and choose the Item tab.

7. In the Inspection Plan section, choose the Select Inspect. Plan button.

8. On the Selection: Display of Packages Used in Inspection Plans screen, choose Execute.

A list of inspection plans meeting your selection criteria is displayed. These inspection plans have the same strategy assigned to them as the one assigned to this testing schedule (QSTABI in the present scenario). For each inspection plan in the list, the list also shows the operations with the assigned testing sequences (packages).

Inspection plan STABI 01 is used for the storage conditions Temperature 25 °C, rel.

Humidity 60% and Temperature 30 °C, rel. Humidity 70% while STABI 02 is used for the

storage condition Temperature 40 °C, rel. Humidity 75%.

9. Select the checkbox for the IPP-017 01 stability study, then choose the Select Inspection Plan (F2) button. The inspection plan is assigned to the storage condition.

10. Choose the Item overview tab.

11. Repeat steps 6 to 10 for the second row using the IPP-017 01 stability study. 12. Repeat steps 6 to 11 for the third row using the IPP-017 02 stability study. 13. Choose Save.

14. Choose the Tasks tab. The Testing Schedule changed task is displayed in the task list. This task was automatically created by the follow-up function for changing the testing schedule.

Result

An inspection plan was assigned to each storage condition (item) of the testing schedule.

4.3.4 Completing the Testing Schedule

Use

You complete the testing schedule to confirm that all scheduling activities have been completed for the storage conditions.

Procedure

(25)

Transaction

code QM02

Business role

3. On the Change Notification: StabilStudy with Mat screen, choose the Complete Test Scheduling button.

4. On the Complete Test Scheduling for Stability Study dialog box, choose Yes. 5. Choose the Tasks tab.

The Testing Schedule completed task is displayed in the task list. This task is automatically created by the follow-up function for completing the testing schedule.

Result

The testing schedule has been completed. Afterwards the storage list can be printed.

4.3.5 Printing the Storage List

Use

The storage list contains information on how to divide up the initial sample into the quantities for the stability samples and it identifies the storage conditions under which the stability samples are stored. The list gives you the specific information:

 A description of each storage condition

 A description of the physical sample associated with each storage condition

 The physical-sample quantity to be created for each storage condition (system proposal)  The number of tests to be performed for each storage condition

In this list, you can also record the storage location of each stability sample, along with the actual physical-sample quantity you created and stored for each storage condition.

Procedure

1. Call up the Change Notification transaction as follows:

→ Change

Transaction

code QM02

(26)

Business role Quality Specialist

Business role

3. On the Change Notification: StabilStudy with Mat screen, from the menu bar, choose Notification

Print Notification

  .

4. On the Select Shop Papers dialog box, select the row for the Storage List.

5. In the OutputDevice column for the selected row, enter the printer name and select the Print

Immediately checkbox.

6. To view the storage list before you print it, choose Print preview. A print preview is displayed on the screen.

Adapt the SAPScript form to your needs in a customer project. 9. Choose Back to return to the dialog box.

10. Choose Print/Fax to print the storage list. 11. The notification is saved automatically.

Result

The storage list has been printed.

4.3.6 Maintaining the Storage Data

Use

You now place the stability samples into storage under the predefined storage conditions and then maintain the storage data for each stability sample in the system (for example, date of storage, location, and quantity of each stability sample stored). Once you have entered and saved this data, the system automatically releases the stability sample for each storage condition, allowing you to define a start for the stability study.

Procedure

→ Change

Transaction

code QM02

(27)

Business role

3. On the Change Notification: StabilStudy with Mat screen, choose the Store Stability Samples button on the right pane.

4. On the Store Stability Samples (Storage Conditions) dialog box, select all rows with data, then make the following entries for each row:

Field

name Description User action andvalues Comment

Quantity Sample Quantity for each storage condition

20 The quantity proposed by the system is the default quantity. Overwrite this value with the quantity that you actually place into storage.

Sample

Location Storage Location for the samples

YP0000000001 Enter the location of the storage condition where you store the stability sample.

No. of

Labels Number of Labels

1 An entry for this field is optional. If you enter a value, the system prints the labels when you save the stability study. You can also print the physical-sample labels at a later time using the

corresponding follow-up function in the action box.

6. Choose the Tasks tab. The Stability Samples Stored; Print Labels task is displayed in the task list. This task was automatically created by the follow-up function for maintaining the storage data.

Result

The storage data is maintained.

4.3.7 Defining the Start Date for the Stability Tests

Use

With defining the start date for the stability tests the system automatically calculates all test dates for the entire duration of the stability study. The test dates are calculated based on the data you

maintained in the testing schedule.

Procedure

(28)

→ Change

QM02

Business role

3. On the Change Notification: StabilStudy with Mat screen, choose the Define Start Date of Study button on the right pane.

4. On the Define Start of Cycle dialog box, in the Start of cycle field, enter the current date and choose the And Change Notification button.

Result

The system calculates all test dates for the entire duration of the stability study. The duration of the study corresponds to the value you entered for the Scheduling Period when you created the testing schedule.

4.4 Performing the Stability Tests

In this phase of the stability study, you perform the stability tests for the storage conditions on the scheduled dates.

4.4.1 Deadline Monitoring

Use

Usually a background job that creates inspection lots for the impending test dates is set up. In the present scenario, we use the deadline monitoring function to create inspection lots for stability testing.

Procedure

1. Call up the deadline monitoring transaction as follows:

Option 1: SAP Graphical User Interface (SAP GUI) SAP ECC

Menu Logistics → Quality Management → Stability Study → Stability Planning → Testing Schedule → Deadline Monitoring

Transaction

code IP30

Option 2: SAP NetWeaver Business Client (SAP NWBC) via business role Business role Maintenance Employee

(29)

Business role

menu Product Maintenance → Maintenance Planning → Planning → MaintSchedule Date Monitoring

2. On the Deadline Monitoring for Maintenance Plans (Batch Input

IP10) screen, enter the following required data:

Field name Description User action and values

Comment

Maintenance

Plan Number of the Testing Schedule PH1000 The testing schedule is a special type of maintenance plan. Maint. Plan cat. Category of the

maintenance plan

ST In the standard system, the maintenance plan category ST is provided for stability studies Interval for Call

Objects Number of days added to the system date

100 The program generates an

inspection lot for each scheduled inspection date in this interval.

A variant must be previously defined. 3. Choose Execute (F8).

4. The system displays a log screen.

Result

Inspection lots for each scheduled inspection date within the given time period have been created. Results can be recorded and the usage decision can be made for these inspection lots, as described in the previous steps Initial Testing – Results Recording and Initial Testing Usage Decision.

4.4.2 Display Stability History

Use

Recorded Results for all inspection lots related to the stability study, grouped by storage conditions, can be displayed.

Procedure

→ Change

QM02

Quality Management → Quality Notifications → Change Quality Notification

(30)

3. On the Change Notification: StabilStudy with Mat screen, choose the Display Stability History button.

4. On the Display Stability History dialog box, the system displays the storage conditions and initial testing. Choose Continue to leave the dialog box.

4.4.3 Goods issue of samples (CO cost center)

Use

Consumption of samples is not posted automatically. Perform this process step manually.

Procedure

1. Call the transaction as follows:

SAP menu Logistics → Materials Management → Inventory Management → Goods Movement → Goods Issue

MB1A

Option 2: SAP NetWeaver Business Client (SAP NWBC) via business role Business role Warehouse Clerk

(SAP_NBPR_WAREHOUSECLERK_S)

Warehouse Management → Consumption and Transfers → Goods Withdrawal

2. On the Enter Goods Issue: Initial Screen, make the following entries: :

Field name Description User action and values

Comment

Movement

Type 333 Consumption from unrestricteduse

Plant 1000

Storage

Location 10Q5(or 1070 if WM is

activated) 3. Choose Enter.

4. On the Enter Goods Issue: New Items screen, make following entries:

Field name Description User action and values Comment

Material PH-6601

Quantity 100 change quantity if required

Batch <batch number>

5. Choose Enter.

(31)

7. Choose Post.

Result

Goods issue of samples used for stability study carried out.

4.5 Completing the Stability Study

When you complete a stability study, you bring the study to a close (typically after all stability tests have been performed as originally planned).

4.5.1 Completing the Stability Study

Prerequisites

You can only complete a stability study if no open test dates are pending in the testing schedule (for example, dates that have not been called, confirmed, or skipped).

Procedure

→ Change

QM02

Business role

3. On the Change Notification: StabilStudy with Mat screen, choose the Complete Stability Study button on the right pane.

4. You may receive a dialog box with the message Completion not possible: There are outstanding

dates for follow-up test. Choose Continue.

Result

The testing schedule and all physical samples belonging to the stability study are locked and the status COMP is set in the stability study. If the aforementioned information message comes up the status cannot be set to COMP.

(32)

5 Appendix

5.1 Used Forms

Use

In some of the activities of this business process, forms are used. The table below provides details on these forms.

If forms are used in the business process described in this document, list them all in the following section:

Example:

Common Form

Name Form Type Used in Process Step Output Type Technical Name

Stability Study in Sap Qm

ERP 6.0

September 2012

Pharma: Stability Study in

Quality Management (P65)

Copyright

Icons

Typographic Conventions

Contents

Stability Studies in Quality Management (P65)

1 Purpose

2 Prerequisites

2.1 Master Data and Organizational Data

Manufacturing / Trade

2.2 Business Conditions

2.3 Roles

Use

Prerequisites

3 Process Overview Table

4 Process Steps

4.1 Initiating the Stability Study

4.1.1

Creating a Stability Study

Use

Prerequisites

Procedure

Result

4.1.2

Creating Physical Sample Record for the Stability Study

Use

Procedure

Result

4.1.3

Assigning a Stability BOM (Optional)

Use

Procedure

Result

4.1.4

Confirm the Receipt of the Initial Sample

Use

Procedure

Result

4.2 Initial Testing

Use

4.2.1

Creating the Initial Test Inspection Lot

Procedure

Result

4.2.2

Result Recording

Use

Procedure

Result

4.2.3

Usage Decision

Use

Procedure

4.3 Planning Stability Tests

Use

4.3.1

Specifying Storage Conditions

Prerequisites

Result

4.3.2

Creating the Testing Schedule

Use

Prerequisites

Procedure

Result

4.3.3

Processing the Testing Schedule

Use

Prerequisites

Procedure

Result

4.3.4

Completing the Testing Schedule

Use

Procedure

Result