Supporting a Good Manufacturing Practice (GMP) compliant production process in SAP S/4HANA involves implementing features that ensure process control, data integrity, and complete traceability.

1. Digital Signatures are used to electronically and securely approve critical process steps, master data changes, or quality results, fulfilling requirements like FDA 21 CFR Part 11 for electronic records and signatures.

2. Recipe Approval ensures that the master recipe, which defines the entire manufacturing process, is formally reviewed and approved before use. This is managed through status networks and engineering change management, preventing unauthorized process variations.

3. The Batch Record provides a complete, documented history of a production batch, capturing all materials, resources, process steps, quality data, and deviations, which is a fundamental requirement for GMP traceability and auditing.

B. Approved resources: This is an operational practice achieved by correctly defining resources within an approved master recipe, not a distinct SAP compliance feature in itself.

D. GMP-compliant flag: A simple flag is a classification indicator. It does not actively enforce or support the compliant execution of a process; compliance is achieved through functional controls like signatures and records.

1. Digital Signature: SAP S/4HANA Help Portal

Digital Signature. "The digital signature is a tool for use in approval processes... It helps you to meet the requirements for digital signatures that are defined

for example

in the GMP guidelines (Good Manufacturing Practices) or in 21 CFR Part 11 of the US Food and Drug Administration (FDA)." (Accessed for S/4HANA 2023).

2. Recipe Approval: SAP S/4HANA Help Portal

Master Recipe

section on Status Management. "You can use statuses to document the processing status of a recipe and control the business transactions that are permitted for it... For example

you can ensure that a recipe is approved before it is used in production orders." This control is a cornerstone of GMP. (Accessed for S/4HANA 2023).

3. Batch Record: SAP S/4HANA Help Portal

Batch Record. "In many industries

especially in the process industry

manufacturers are legally required to document the production process and the data of a batch in a batch record... The SAP batch record meets the requirements of GMP." (Accessed for S/4HANA 2023).