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🏆 PIC/S GMP · QUALITY & GOVERNANCE
Asia's First Private GMP-Certified Radiopharmaceutical Facility
Racing Every Second. High Standards for 15 Years.
Every Dose, A Commitment.
Achieving PIC/S GMP certification in 2014, Petpharmbio operates under Asia's highest pharmaceutical manufacturing standards, ensuring absolute quality from synthesis to delivery for every single dose.
🏆 2014 · MILESTONE
Asia's First Private PIC/S GMP Certified Sterile Radiopharmaceutical Facility
Excluding government institutes and medical centers, Petpharmbio became the first private radiopharmaceutical facility in Asia to achieve PIC/S GMP certification in 2014—a record that remains unmatched and serves as our core competitive moat.
2014
First Certified Year
15+
Years Zero Supply Error Record
8
TFDA Drug Approvals
#1
Private GMP Radiopharmaceutical Plant in Asia
CERTIFICATION STANDARDS
What Does PIC/S GMP Stand For?
Aseptic Manufacturing Control
Fully enclosed aseptic isolation technology eliminates contamination risks, ensuring the sterility and stability of every production batch meet international standards.
Comprehensive QA / QC System
Dual-track quality management with a Qualified Person (QP) authorization system ensures rigorous review before official batch release, with fully traceable records.
Global Inspection Benchmark
PIC/S is recognized by drug regulatory authorities across 56 countries. Achieving certification signifies passing inspections equivalent to top-tier global standards.
The Certificate is a
Tangible Proof of Our Commitment
Petpharmbio's PIC/S GMP certificate is issued by the Taiwan Food and Drug Administration (TFDA), confirming that our manufacturing environment, process controls, and quality systems have passed the most stringent on-site audits.
Every Dose, A Commitment.
QUALITY MANAGEMENT SYSTEM
End-to-End Quality Control From Raw Materials to Delivery
Supplier Qualification Governance
All raw material suppliers undergo rigorous qualification audits, including GMP compliance reviews and regular on-site inspections to control quality at the source.
Tungsten Container Digital Tracking
Taiwan's unique digital tracking system for tungsten containers monitors transit status from manufacturing to client sites in real time, ensuring container safety and timeliness.
Time-Critical Logistics System
For radiopharmaceuticals with ultra-short half-lives, Petpharmbio operates a dedicated delivery fleet and real-time scheduling system to ensure medicines reach clinics at peak activity.