Canaan Integrated Line Supports Successful PIC/S GMP Certification in Indonesia

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Blog - Canaan Integrated Line Supports Successful PIC/S GMP Certification in Indonesia
Canaan Focus

An important partner of Canaan Technology, a leading pharmaceutical manufacturer based in Singapore, has recently announced that its newly built facility in Indonesia has successfully achieved PIC/S GMP certification.

This milestone confirms the company’s capability to meet stringent international regulatory standards—and highlights the robustness and consistency of Canaan’s integrated line solutions in highly regulated environments.

From Proven Delivery to Continued Trust

The collaboration between the two parties extends beyond a single project. Following the successful delivery of the Singapore facility, the client established strong confidence in Canaan’s equipment quality, engineering capabilities, and project execution.

Building on this foundation, Canaan was once again selected as the integrated solution provider for the Indonesia project, delivering a complete granulation production line covering:

  • Upstream processing
  • Wet granulation
  • Fluid bed drying
  • Tablet compression
  • Coating
  • Blister packaging

In addition, Canaan provided a full set of validation documentation services covering the entire project lifecycle.

Client Profile and the Value of PIC/S GMP Certification

The client is an established manufacturer with decades of experience in generics and nutraceuticals. With a broad and diversified product portfolio, the company has developed a strong presence in both domestic and international markets, supported by extensive expertise in contract manufacturing and product exports.

PIC/S GMP is widely recognized as a global benchmark for pharmaceutical manufacturing. Certification indicates that a facility meets high standards across key areas including:

  • Quality management systems
  • Data integrity
  • Cleaning validation
  • Computerized systems

Achieving PIC/S GMP certification enhances the client’s ability to access regulated markets and supports its long-term international growth strategy.

Value Delivered and Project Significance

Under PIC/S GMP requirements, compliance is not determined by individual equipment performance alone. It depends on the consistency and integrity of the entire production system—from process integration to documentation readiness.

Canaan’s integrated solution was designed and delivered with compliance built in at every stage:

  • Optimized line layout, supporting logical process flow and regulatory alignment
  • Equipment design focused on cleanability and maintainability
  • In-house control systems, ensuring data integrity at system level
  • Accurate control of critical process parameters (CPPs)
  • End-to-end validation documentation, ensuring full traceability

Beyond equipment delivery, Canaan provided a complete validation package in line with PIC/S requirements, including DQ, IQ, OQ, and PQ documentation.

Each phase—from design qualification to performance qualification—is fully documented, enabling the client to maintain an audit-ready state throughout inspections. All records are traceable, ensuring transparency across the entire lifecycle—from equipment manufacturing to on-site operation.

Supporting Global Pharmaceutical Manufacturing

The successful PIC/S certification of the Indonesia facility marks more than the completion of a single project. It reflects Canaan Technology’s continued advancement toward global markets and high-standard pharmaceutical manufacturing.

Canaan’s integrated solutions are designed to align with major international regulatory frameworks, including EU GMP and PIC/S standards, delivering consistency, reliability, and verifiable compliance.

By combining advanced equipment, integrated engineering capabilities, and comprehensive validation services, Canaan continues to support pharmaceutical manufacturers worldwide in meeting regulatory requirements and expanding into global markets.

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