In our “Meet our Experts” series, we are excited to introduce you to some of Stoecklin’s subject matter experts who give their input on several different topics related to warehousing and automated storage solutions.

Today it is our pleasure to introduce Marcel Schaub – Head of System Engineering for the Automation and Warehouse Software Department (based out of Switzerland). Marcel has been in the logistics and warehousing industry for 25 years, and at Stoecklin for 12 years. Being an expert in Automation, Warehousing and Software development, Marcel was so kind to answer a couple of questions regarding what is important to consider when implementing SAP-EWM in GMP environments.

Marcel Meet Our Experts

 

Things to consider when implementing an automated system in A GMP environment.

1.  What are some of the things that customers may not think about when exploring an automated system in a GMP environment?
Good Manufacturing Practices or GMP requirements are often part of a production environment. In automated warehouse systems, at first glance, it is often not apparent whether the material flow processes are GMP compliant or not. However, as soon as goods are moved through air-conditioned areas, stored in air-conditioned areas and picked, GMP requirements are likely to apply. GMP requirements sometimes even apply to Programmable Logic Configurations (PLC) configurations.

2.  SAP EWM is quite commonly used in GMP environments? Does the host system that is used change your answer to question 1?
GMP requirements apply regardless of the software (manufacturer) used. However, SAP EWM is specifically geared to GMP requirements due to the widespread use of the software. If a Material Flow System (MFS) module is included in the SAP EWM, and thus a material flow system of the plant manufacturer is not required, the validation can be reduced to just one system. For larger plants, however, the advantages of an in-house material flow system outweigh the disadvantages of having two separate systems, as the in-house MFS has been optimized and aligned with the automated system.

3.  GMP requirements are usually required because of regulations. Are there hidden benefits to automation in a GMP environment other than meeting regulations?
The short answer is yes. First off, GMP requirements serve as a guideline throughout the implementation phase of a project, as they provide very useful implementation specifications. This involves topics such as data security and very restrictive software release planning as to when systems go live, and reduces the susceptibility to errors after release changes.

The extensive documentation required by GMP allows the software to be reliably maintained even after years of operation and simplifies a possible software migration in the event of an upgrade.

4.  What is one thing you would advise companies, who need to implement a system in a GMP environment?
Prior to the implementation of the system, it should be determined and clarified with qualified experts if and how the material flow processes will have to comply with GMP requirements. The validation processes for automated systems differ significantly from the processes for manual systems. Thus it is recommended to set up the GMP validation as a separate project with external experts to allow for enough time for a proper GMP validation process of the system.

5.  What is one drawback that may not be obvious?
GMP validation usually comes with a noticeable increase in time and costs throughout the implementation phase. GMP change management must also be considered and maintained after the commissioning of the system and during the subsequent operation of the plant to keep the plant and systems up to date.

6.  How do you feel this may change in the future?
This is difficult to answer. If GMP validation is extended to other industries, it is possible that validations will become more efficient as knowledge about GMP validation becomes more widespread and accessible. Special change management processes and programs that allow for more efficient changes to existing systems already exist.

7.  Other than changes in regulation requirements, what reasons could influence greater adoption of automation in GMP environments?
Automation also means increased operational reliability in many cases. Human error is mostly eliminated. Automation, meaning the machines, produce more accurate results and replicate those. Since accuracy and traceability play an important role in GMP environments, automation is an important component of GMP compliance.