206665251 P65 Pharma Stability Study in Quality Management ERP606 Process Overview en XX

Pharma: Stability Study in Quality

Management (P65)

SAP Best Practices

2012 SAP AG. All rights reserved. 2

Purpose, Benefits, and Key Process Steps

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.

Benefits

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.

Expiry date determination (needed for market approval of a product)

Retest samples (in case of complaints)



Key Process Steps

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

stages:

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:

a)Create a physical-sample record for the initial sample to be delivered to your

laboratory. *

b)Assign a stability bill-of-material to the stability study (only if the study is being

conducted regarding a material). *

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



Key Process Steps-2

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:

a)Create an inspection lot for the initial sample. *

b)Perform the initial test by inspecting the initial sample and recording your test

results.

c)Complete the initial test by making the usage decision for the inspection lot.



Key Process Steps-3

3)Stability Planning

In the stability planning phase, perform the following activities:

a)Specify the storage conditions under which the stability samples is stored in this stability study.

b)Create a testing schedule to plan the scope and frequency of the stability tests.

c)Create separate inspection plans for each storage condition.

d)Process the testing schedule to assign the inspection plans to the respective storage conditions.

e)Complete the testing schedule.

f)Print the storage list. The system automatically calculates the quantities needed for the stability

samples and prints these quantities on the storage list.

g)Maintain the storage data for the stability samples in the system.

h)Physically create the stability samples, print and affix the physical-sample labels, and place the

samples in storage under the predefined storage conditions.

i)Define a start date for the stability study.

The system automatically calculates all test dates for the duration of the study.



Key Process Steps-4

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:

a)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).

b)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.

c)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.

d)Analyze the stability study process by performing evaluations.



Key Process Steps-5

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:

a)Cancel the stability study for all storage conditions or for selected storage conditions at any time

b)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)


Required SAP Applications and Company Roles

Required SAP Applications

Enhancement package 6 for SAP ERP 6.0

Company Roles

Quality Specialist

Maintenance Employee

Warehouse Clerk


Process Flow Diagram Pharma: Stability Study in Quality Management

SAP 2008 / Page 9

Creating Physical Sample Record for the stability

Study

Wa

reh

ou

se

C

lerk

Creating Stability Study

Confirm the Receipt of the Initial Sample

Ma

inte

na

nc

e

Em

plo

ye

e

Qu

ali

ty S

pe

cia

lis

t

Creating the initial Test Inspection

Lot Assign Stability BOM

Results Recording

Usage Decision

Specifying Storage

Condition

Creating the Testing Schedule

Processing the Testing Schedule

Completing the Testing Schedule

Printing the Storage List

Maintaining the Storage Data

Defining the Start date for the

Stability Study

Deadline Monitoring

Display Stability History

Goods Issue of sample (CO cost

center)

Completing the Stability Study


Legend

Symbol Description Usage Comments

To next / From last Diagram: Leads to the next / previous page of the Diagram

Flow chart continues on the next / previous page

Hardcopy / Document: Identifies a printed document, report, or form

Does not correspond to a task step in a document; instead, it is used to reflect a document generated by a task step; this shape does not have any outgoing flow lines

Financial Actuals: Indicates a financial posting document


Budget Planning: Indicates a budget planning document


Manual Process: Covers a task that is manually done

Does not generally correspond to a task step in a document; instead, it is used to reflect a task that is manually performed, such as unloading a truck in the warehouse, which affects the process flow.

Existing Version / Data: This block covers data that feeds in from an external process

Does not generally correspond to a task step in a document; instead, this shape reflects data coming from an external source; this step does not have any incoming flow lines

System Pass / Fail Decision: This block covers an automatic decision made by the software

Does not generally correspond to a task step in the document; instead it is used to reflect an automatic decision by the system that is made after a step has been executed.

Exte

rnal

to S

AP

Business Activity / Event

Unit Process

Process Reference

Sub-Process

Reference

Process Decision

Diagram Connection

Hardcopy / Document

Financial Actuals

Budget Planning

Manual Process

Existing Version /

Data

System Pass/Fail Decision

Symbol Description Usage Comments

Band: Identifies a user role, such as Accounts

Payable Clerk or Sales Representative. This band

can also identify an organization unit or group,

rather than a specific role.

The other process flow symbols in this table go

into these rows. You have as many rows as

required to cover all of the roles in the scenario.

Role band contains

tasks common to that

role.

External Events: Contains events that start or end

the scenario, or influence the course of events in

the scenario.

Flow line (solid): Line indicates the normal

sequence of steps and direction of flow in the

scenario.

Flow line (dashed): Line indicates flow to

infrequently-used or conditional tasks in a

scenario. Line can also lead to documents involved

in the process flow.

Connects two tasks in a scenario process or a non-step event

Business Activity / Event: Identifies an action that either leads into or out of the scenario, or an outside Process that happens during the scenario

Does not correspond to a task step in the document

Unit Process: Identifies a task that is covered in a step-by-step manner in the scenario

Corresponds to a task step in the document

Process Reference: If the scenario references another scenario in total, put the scenario number and name here.


Sub-Process Reference: If the scenario references another scenario in part, put the scenario number, name, and the step numbers from that scenario here


Process Decision: Identifies a decision / branching point, signifying a choice to be made by the end user. Lines represent different choices emerging from different parts of the diamond.

Does not usually correspond to a task step in the document; Reflects a choice to be made after step execution


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206665251 P65 Pharma Stability Study in Quality Management ERP606 Process Overview en XX