SAP BASIS and GMP. Step-by-Step guide for CR

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products,  dietary supplements,  and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user  Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS)

If your company following to GMP principles usually a lot of SAP-systems in this company (SAP ERP QM/SD/MM/PP and PP/DS modules, SAP TM, SAP EWM, SAP ATTP and so on) are GMP-critical. This fact affects the work of all SAP Consultants in the company, including SAP BASIS Administrator too.

For example:

You are SAP BASIS Administrators and you need a fix a UOM-error in SAP EWM<-> SAP ERP integration with notes:

Your landscape looks as DEV – QAS – PRD (Where PRD are SAP EWM GMP-Validated System)

Notes implementation in DEV and QAS.

Implement notes in DEV system and create a new transport request then moved it into QAS system (This action needed for Risk Analysis)

Fill out CR, RA.

You want to change a GMP-Validated System hence your together with Functional Consultant need open a Change Request (CR) and fill out a Risk Analysis (RA) form

CR:

The form of CR depends on your company but basically contains such field as Date, Department, Related Persons, Change Object, Change Reason and so on

RA:

The form of CR depends on your company but basically based on Risk Assessment Matrix (example below)

CR + RA Approved via the Validation team (for example in Jira)

Fill out of OQ Protocol.

The Operational Qualification Protocol (OQ) is a collection of test cases used to verify the proper functioning of a system. The OQ test requirements are defined in the Functional Requirements Specification. OQ is usually performed before the CR is released to the production system.

For our UoM-notes OQ contains testing of good movements in UoM, BoM from EWM QAS to ERP QAS after notes implementation.

OQ Approved via Validation team (for example in Jira)

Notes implementation in PRD.

Transport request with notes moved into PRD system.

Fill out of IQ Protocol.

The Installation Qualification (IQ) means showing it is set up, connected and installed as planned.

For our UoM notes IQ contains the result of monitoring of good movements from EWM PRD to ERP PRD, SMQ2 monitoring and so on.

This is a first blog post from series about SAP BASIS and GMP.

Links:

GMP COMPUTERISED SYSTEMS

GUIDELINES Data Integrity & Computer System Validation

What Are IQ, OQ, and PQ, and Why Are They Required In The Pharmaceutical Industry?