Tested To Trust: DDE’s CQV Journey

In biopharma and pharma manufacturing, Commissioning, Qualification, and Validation (CQV) form the dynamic trio that successfully transforms design intent into operational brilliance. Commissioning, Qualification, and Validation (CQV) isn’t just about meeting regulations—it's also about ensuring that bioprocess systems are validated for commercial use with a focus on safety, performance, and operational efficiency. Well-executed CQV establishes confidence in the reliability and quality of the products while minimizing risks and downtime.

Regulatory Guidelines for Commissioning and Qualification

?Regulatory guidelines for Commissioning and Qualification ensure bioprocess systems hit the trifecta of safety, quality, and compliance. From The ISPE Baseline Guide: Commissioning and Qualification (Second Edition) to GMP and ASTM E 2500 to FDA’s Process Validation and ICH Q8-Q10, these frameworks champion a risk-based, step-by-step approach. With mandates from the FDA, European Commission, and TGA, aligning with these guidelines protects product integrity and clears the path for faster regulatory approvals. By adhering to the highest CQV standards, DDE’s bioprocess solutions ensure compliance with global regulations;(USFDA, MHRA, WHO) and deliver sustainable, future-ready systems to over 50 countries, highlighting its commitment to excellence in safety and operational synergy.

Challenges Worth Tackling, Trust Worth Earning

In bioprocessing, building trust through Commissioning, Qualification and Validation (CQV) is vital. To earn this trust, several critical challenges must be addressed.

· Precision: Advanced automation, multi-vendor gear, and intricate control systems need to sync perfectly and precisely.

· Traceability:?Meeting stringent global standards requires comprehensive documentation and maintaining data integrity—ensuring every piece of data is traceable.

· Time crunch: A delay in equipment or testing can drive up costs and disrupt project schedules.

· Scalability: Transitioning to full-scale production often introduces variability—this leads to optimizing the batch control parameters.

· Operational Success: Getting the team up to speed on new technologies, operation manuals, protocols, and training isn’t optional; it’s the key to ensuring long-term operational success.

These challenges, far from being mere obstacles, present opportunities to drive excellence and foster lasting confidence in the final product.

Cracking the Code — DDE’s approach

DDE combines decades of experience with a comprehensive approach to system installation, qualification, and validation—enabling the efficient and reliable delivery of innovative therapies to market. One of our core areas of expertise lies in a well-designed Commissioning Qualification and Validation (CQV) process that ensures seamless verification of the system with supportive documents, protocols, and reports.

We create a comprehensive plan?for each project that is meticulously aligned with client specifications and regulatory standards and implement risk assessment?strategies for the early identification and mitigation of potential risks. This proactive approach?ensures that all necessary compliance and quality considerations are addressed early on, setting a solid foundation for the entire project. With every step, we aim for precision, reliability, and unmatched quality that complies with the intended purpose of the system.?

· Design:?The foundational document that defines the technical and operational specification needs to be made foolproof. DDE follows the principles of?Quality by Design?(QbD),?ensuring that compliance with current Good Manufacturing Practices (cGMP)?and User Requirements Specifications (URS)?are integrated into the design phase.?

· System Specifications: Critical documents, including the User Requirements Specification (URS), Functional Requirements Specification (FRS), and Design Specifications (DS), outline system needs, functionality, and design precisely.

· Design Qualification (DQ):?Provision of cGDP documents—including proposed design, components, functionality, and equipment that are suitable for the intended purpose—to the client.

· Mechanical Pre-FAT: Verification of physical components and systems assures mechanical integrity and proper setup.

· Automation Pre-FAT: Thorough testing of the automation systems ensures seamless operation.

· Qualification Documentation System:?Monitors commissioning tests (FAT-SAT), wipes out non-conformities, reports workflows, and standardizes test protocols.

· Factory Acceptance Testing (FAT-IOQ): Our dedicated FAT center with testing bays?is equipped with clean and black utilities, instruments, and testing equipment to simulate?the conditions of the client facility and provides for static and dynamic testing. These meticulously performed tests ensure that every piece of equipment is?fully prepared for deployment.

· Site Acceptance Testing (SAT-IOQ): On-site testing ensures systems are correctly installed and function as intended in the operational environment. SAT helps us identify any discrepancies or issues that may arise in the real-world setting, allowing for timely adjustments before full-scale operation.

· Flawless Compliance: Mitigates uncertainties and ensures that the systems meet operational and regulatory standards.

· Documentation and Certification: Every step, test, and decision is recorded, ensuring compliance and establishing a paper trail for the future.

DDE also delivers well-documented operating and maintenance manuals, operator training, and post-commissioning assistance to our clients.

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Execution Beyond Expectations

DDE's dedicated Quality Assurance and Validation (QAV) team, consisting of experts in mechanical, manufacturing, and technical domains, excels in effectively managing challenges like system readiness and inspection reports on manufacturing documents, piping & assembly, automation hardware connections, wiring, utility readiness, power supply, I/O testing, mechanical verification, simulations of alarms, interlocks, and automation sequences.

By addressing deviations proactively during the Pre-FAT phase, the QAV team ensures robust quality control. Simulations spot issues early, and a real-time monitoring system tracks performance and reports on deviation. This significantly reduces the risk of delays or failures during the official FAT process—a critical factor for meeting the timely delivery of vessels to our clients.

DDE’s FAT process?comprehensively addresses all critical aspects of system readiness, from mechanical integrity to process performance, before they are delivered to the client. Typical stages in the FAT process include:

• Drawing Verification

P&ID, GA, 3D, Isometric drawings, Electrical drawings, System Architecture

• BOM Verification
• Mechanical Verification
• Document Verification

Vessel & piping manufacturing documents

Bought-out components and certificates

• Calibration Verification of Instruments
• Manufacturing Document Verification
• Document Verification
• Automation & Control System Verification (fully compliant as per 21 CFR Part 11)
• I/O Testing
• Safety, Alarms, and Interlock Verification
• Sequence Verification

CIP, PHT, SIP, Process Sequence

• Process Performance Testing
• FAT Protocol Verification

DDE stands out as a leader in Commissioning, Qualification and Validation (CQV), having completed numerous projects that showcase our expertise and reliability. With a customer-first approach, we provide equipment that’s ready to perform from day one and go beyond meeting project needs—exceeding expectations and delivering lasting value. It gives us immense joy to share some overwhelming testimonials we received from the client during a recent project recognizing our FAT capabilities.

“The process was smooth. The technical team involved was very knowledgeable and cooperative. The vessel FAT was up to our expectations. Overall, it was an amazing experience.” Manager, Inhalation R&D

“The execution of the equipment FAT was more than our expectation. This project has increased my expectation from DDE for future projects.” Associate Vice President, Inhalation R&D

“FAT was successfully completed as per our expectations.”?Vice President & Head, Inhalation R&D

With strategic planning, thorough testing, and a focus on innovation, DDE has set the gold standard in C&Q excellence.

A Journey of Continuous Improvement

While this feedback fills us with immense pride, we know that the pursuit of excellence is a journey, not a destination. DDE remains committed to upholding the highest standards in CQV, capturing lessons learned, and uncovering opportunities for continuous process enhancement. Through our continuous post-commissioning support, we strive and deliver the benchmark for success in the industry—driving innovation and quality forward every day.