DRAP Track and Trace & Serialization Solutions in Pakistan

DRAP-compliant serialization and aggregation systems aligned with SRO 962(I)/2019 and GS1 DataMatrix standards

DRAP-Compliant Track and Trace Solutions for Pakistan Pharma

Sunshine Corporation Pakistan provides DRAP-compliant track and trace and serialization solutions for pharmaceutical manufacturers operating under SRO 962(I)/2019.

Our DRAP serialization and aggregation systems are designed for high-speed packaging lines while maintaining regulatory-grade data integrity, audit readiness, and long-term system sustainability. The solution supports unit-level serialization, aggregation, and structured regulatory reporting aligned with DRAP enforcement requirements.

Sunshine Corporation is an experienced DRAP serialization vendor in Pakistan, delivering GS1-compliant SSAS implementations for multi-line pharmaceutical plants.

DRAP Serialization & Track and Trace Requirements (SRO 962(I)/2019)

The Drug Regulatory Authority of Pakistan (DRAP) mandates serialization and track and trace implementation under SRO 962(I)/2019, requiring pharmaceutical manufacturers to implement:

• GS1 DataMatrix encoding
  
  

• Unit-level serialization
  
  

• Aggregation (Item → Carton → Shipper → Pallet)
  
  

• Secure electronic audit trails
  
  

• Structured reporting for DRAP inspections
  
  

• Long-term data retention and traceability
  
  

As of September 2025, DRAP has entered the formal enforcement phase, making production-grade serialization systems mandatory across Pakistan pharma plants.

Sunshine SSAS – DRAP Serialization Architecture

Sunshine’s SSAS (Serialization & Supply-chain Assurance System) is based on a Distributed Deterministic State Machine using a 3-Tier Architecture:

• Tier 1 – Plant-Level Execution

• Tier 2 – Line-Level Coordination

• Tier 3 – Machine Host & Regulatory Reporting

This architecture ensures DRAP track and trace compliance without limiting production throughput, supporting speeds exceeding 350 packs per minute (PPM).

GxP Data Integrity & DRAP Audit Readiness

DRAP inspections increasingly follow PIC/S-aligned data integrity expectations. Sunshine SSAS incorporates:

• Mandatory GxP Reason Codes for all critical data actions

• Two-component electronic signatures

• Cryptographic hashing of audit trails

• SQL-level protection using DENY UPDATE / DELETE

• Forensic-grade traceability suitable for national inspections

This ensures the system is not only compliant, but audit-defensible.

Deterministic Print-to-Record Control for High-Speed Lines

To prevent serialization mismatches and production losses, the system includes:

• FIFO queue priming to resolve mechanical print lag

• Watchdog heartbeat to prevent ghost printing

• Deterministic cursor execution

• Sub-5 ms database response times

This guarantees a one-to-one match between printed DataMatrix codes and recorded serial numbers, even at 350+ PPM.

DRAP Digital Ecosystem & Pakistan Single Window (PSW)

DRAP is digitalizing regulatory workflows and integrating with the Pakistan Single Window (PSW).

Sunshine SSAS supports:

• Structured XML and JSON reporting

• Compatibility with SQL

• Tiered synchronization (Host → Line → Plant → World)

• Continued line operation during network interruptions

This architecture ensures future readiness as DRAP systems evolve.

Long-Term Sustainability & Lifecycle Management

To meet DRAP’s long-term data retention requirements, Sunshine SSAS includes:

• Automated archival procedures

• Database performance protection against SQL size limits

• Support for processing over one million serials per day

• Designed for 10-year system lifecycle compliance

DRAP Compliance Mapping

DRAP Serialization Implementation Experience in Pakistan

Sunshine Corporation has implemented DRAP serialization and aggregation systems across Pakistan pharmaceutical manufacturing facilities featuring:

• Multi-line packaging operations

• Vision systems, printers, and PLC integration

• Distributed host–plant architectures

• Validation-ready documentation and support

These systems are engineered to transition smoothly from pilot to enforcement.

Post-2024 DRAP Readiness

Sunshine Corporation has implemented DRAP serialization and aggregation systems across Pakistan pharmaceutical manufacturing facilities featuring:

• Designed for September 2025 DRAP enforcement

• Aligned with DRAP inspection training focus

• PSW-ready reporting architecture

• Updated GxP hardening

Last updated: January 2026

Need DRAP Track and Trace Compliance?

Contact Sunshine Corporation Pakistan for:

• DRAP compliance gap assessment

• Serialization & aggregation architecture review

• High-speed line implementation

• Validation-ready DRAP deployments

Contact us to discuss your DRAP track and trace requirements.