"Stability studies provide an overview of the long-term quality of our products."

Industries that are highly regulated and where various national and international regulatory agencies (e.g., the Food and Drug Administration) and international guidelines (e.g., Good Manufacturing Practices) apply define the scope and types of products for which stability studies must be performed (e.g., as prerequisite for market introduction or as a means of periodically testing the product during marketing). SAP stability studies can also be conducted as part of the new product development process. For example, the ideal composition of a product or the most suitable packaging for a product can be determined. This ensures that it meets the ideal stability and shelf-life requirements for the intended storage conditions.

Stability studies or shelf-life studies in SAP are carried out in the chemical, pharmaceutical and food industries, among others, to ensure the long-term quality of products. Among other things, the influence of different environmental conditions such as temperature and humidity on the properties of a product (e.g. colour result of a wall paint or varnish or efficiency of a drug) or a product batch is observed over a certain period of time.

Illustration of the processes in the company

SI PRO Consulting Solutions for SAP QM with S4/HANA

Strategy

Defines the rules for the timing of scheduled stability tests. It contains general scheduling information and can therefore be assigned to as many inspection plans for storage conditions and schedules as necessary. A strategy contains packages that specify the cycle in which each test can be performed.

Initial Test

For the initial test, you manually create an inspection lot, select an inspection plan and the desired inspection characteristics (flexible inspection specifications) for the inspection of the initial sample. You then carry out results recording. Depending on the results of the initial test, you decide whether you want to continue the stability study. By performing the initial test, you ensure that the input sample and subsequent stability samples (formed from the input sample) meet your individual stability study requirements before proceeding with the actual stability test.

Stability Planning

Each stability sample is kept under a specific storage condition. You use the deadline monitoring functions to automatically create inspection lots for the upcoming test dates.

You complete each individual stability test by making a usage decision for the relevant inspection lot. After all stability tests have been completed on all test dates, the stability study is closed.

Sample

In order to be able to make a statement about the shelf-life of a product, for example, samples of the product are formed. Over the entire period of the study, the product is stored under controlled conditions (storage conditions). During the study, these samples or probes of these samples are taken from the storage conditions at specified times and tested according to predefined inspection plans.

Stability Test

You create inspection plans in SAP for the stability study or assign existing ones to the respective stability study. You can also use a separate test plan for each storage condition.

You perform the stability tests for the storage conditions on the planned dates. If necessary, you can also change the test dates and thus, for example, create additional test dates, disregard certain test dates, or create additional, manual inspection lots for different storage conditions.

Storage conditions

You define the storage conditions under which the stability samples are stored. When you select a storage condition and assign it to the stability study, the system automatically creates a sample data record for the stability sample to be stored and tested under the storage condition.

Scheduling

Product development enters all test durations and deadlines relevant for the SAP stability study. The respective start times are added by the laboratory. The necessary test dates are determined from this data. Public holidays and weekends are automatically taken into account and immediately color-coded in order to initiate a corresponding date shift.

Follow-up activities

Defines the rules for the timing of scheduled stability tests. It contains general scheduling information and can therefore be assigned to as many inspection plans for storage conditions and schedules as necessary. A strategy contains packages that specify the cycle in which each test can be performed.

QM Solutions

Food Industry

Providing shelf life or consumption data that is as accurate as possible not only offers an economic advantage, but also enables a more sustainable use of resources. SAP stability studies can make an important contribution here. Not only can the influence of a wide variety of storage conditions over any length of time be mapped, but ideal ingredients, additives, preservatives, and packaging materials can also be found and their influence on the final product determined.

Pharmaceuticals Industry

Stability studies are a central component in the development and approval of new active pharmaceutical ingredients and drugs. Already during the development of a preparation or active ingredient, SAP stability studies can help to determine optimal active ingredients and their concentrations. Even afterwards, the ideal packaging material can be determined by selecting a wide range of storage conditions, such as temperature and humidity, as well as duration. The influence of excipients on the efficiency and stability of products can also be determined in this way. Stability studies thus help to ensure a smooth approval process.

Why you should choose
SI PRO

SI PRO has been advising on SAP QM solutions since the earliest versions were released, and offers the most comprehensive level of best practice know-how.

Our consultants are familiar with specific issues, business processes, the latest SAP solutions, technologies, and appropriate procedures.

We can support you throughout your project’s entire life cycle, from analyzing your requirements to project planning, implementation, and maintenance.

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