Contributing Author: Dr Vidyasagar K Submitted Date: 13 Oct 2023
SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP) supports regulatory compliance by providing a comprehensive solution for pharmaceutical serialization and traceability. It aligns with various pharmaceutical regulations and standards, helping pharmaceutical companies meet their legal obligations. Here's how SAP ATTP supports regulatory compliance and some of the key regulations it aligns with: 1. Serialization and Traceability: SAP ATTP allows pharmaceutical companies to assign unique serial numbers to individual product items, such as bottles or vials. These serial numbers are then associated with higher-level containers like cases and pallets, creating a hierarchical serialization structure. This approach enables end-to-end traceability within the supply chain. 2. Data Management: The system collects, stores, and manages critical data related to product master data, manufacturing, packaging, distribution, and serialization information. It ensures data accuracy and consistency, which is essential for regulatory reporting and compliance. 3. Compliance Reporting: SAP ATTP generates reports and documentation required for compliance with pharmaceutical serialization and traceability regulations. It can produce reports that meet the specific requirements of regulatory authorities and support timely submissions. 4. Verification and Authentication: The system enables verification and authentication of product identifiers at various levels of packaging. This supports compliance with regulations that require stakeholders to verify product authenticity and prevent the distribution of counterfeit or substandard products. 5. Aggregation: SAP ATTP supports the aggregation of serial numbers from individual product items to cases and pallets. This is crucial for compliance with regulations that mandate aggregation as part of the traceability process. 6. Global Standards Compliance: SAP ATTP aligns with global serialization and traceability standards, such as GS1 standards, which are widely accepted in the pharmaceutical industry. Compliance with these standards is essential for international regulatory compliance. Key Regulations Aligned with SAP ATTP: U.S. Drug Supply Chain Security Act (DSCSA): SAP ATTP aligns with the DSCSA, which requires pharmaceutical manufacturers, distributors, and other supply chain stakeholders to implement serialization and traceability processes to enhance the security of the pharmaceutical supply chain in the United States. European Falsified Medicines Directive (FMD): SAP ATTP supports compliance with the FMD, which mandates serialization and traceability requirements for pharmaceutical products in the European Union. Various National Regulations: SAP ATTP can be configured to align with national regulations in countries outside the U.S. and the EU, as needed. This flexibility allows pharmaceutical companies to comply with regulations specific to their regions of operation. Global Pharmaceutical Serialization Standards: SAP ATTP aligns with global serialization standards and industry best practices, making it suitable for use in pharmaceutical markets around the world. By providing serialization, traceability, data management, and reporting capabilities, SAP ATTP helps pharmaceutical companies adhere to regulatory requirements and ensures the safety and integrity of pharmaceutical products within the supply chain. It offers a standardized approach to compliance, reducing the risk of regulatory non-compliance and associated penalties.
SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP) supports regulatory compliance by providing a comprehensive solution for pharmaceutical serialization and traceability. It aligns with various pharmaceutical regulations and standards, helping pharmaceutical companies meet their legal obligations. Here's how SAP ATTP supports regulatory compliance and some of the key regulations it aligns with:
1. Serialization and Traceability:
2. Data Management:
3. Compliance Reporting:
4. Verification and Authentication:
5. Aggregation:
6. Global Standards Compliance:
Key Regulations Aligned with SAP ATTP:
U.S. Drug Supply Chain Security Act (DSCSA): SAP ATTP aligns with the DSCSA, which requires pharmaceutical manufacturers, distributors, and other supply chain stakeholders to implement serialization and traceability processes to enhance the security of the pharmaceutical supply chain in the United States.
European Falsified Medicines Directive (FMD): SAP ATTP supports compliance with the FMD, which mandates serialization and traceability requirements for pharmaceutical products in the European Union.
Various National Regulations: SAP ATTP can be configured to align with national regulations in countries outside the U.S. and the EU, as needed. This flexibility allows pharmaceutical companies to comply with regulations specific to their regions of operation.
Global Pharmaceutical Serialization Standards: SAP ATTP aligns with global serialization standards and industry best practices, making it suitable for use in pharmaceutical markets around the world.
By providing serialization, traceability, data management, and reporting capabilities, SAP ATTP helps pharmaceutical companies adhere to regulatory requirements and ensures the safety and integrity of pharmaceutical products within the supply chain. It offers a standardized approach to compliance, reducing the risk of regulatory non-compliance and associated penalties.
Keywords:#SAPATTP #RegulatoryCompliance #Pharmaceuticals #ComplianceStandards #TechInnovation #PharmaTech #DigitalTransformation #Serialization #DataIntegrity #TrackAndTrace
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