In the pharmaceutical industry, few processes are as vital as commissioning. Whether it’s the installation of a new cleanroom, a bioreactor, a water-for-injection system, or advanced manufacturing equipment, commissioning verifies that every system performs safely, reliably, and in full compliance with regulatory standards. For pharmaceutical companies, where product quality and patient safety are non-negotiable, commissioning is more than just a project step, it’s a key foundation for Good Manufacturing Practice (GMP) compliance and long-term operational success.
GL Technologies takes a look at the importance of commissioning in the pharmaceutical industry, outlines its key stages, highlights best practices, and explains why partnering with an experienced commissioning provider can give companies a competitive edge.
What Is Commissioning in the Pharmaceutical Industry?
Commissioning is the systematic process of planning, verifying, and documenting that facilities, utilities, and equipment are designed, installed, tested, and capable of consistent operation according to the user’s requirements.
In the pharmaceutical context, commissioning goes hand-in-hand with validation, forming part of the Commissioning, Qualification, and Validation (CQV) framework. Unlike general construction projects, pharmaceutical commissioning must meet strict regulatory guidelines, including:
FDA 21 CFR Parts 210 & 211 (U.S. GMP requirements)
EMA Annex 15 (EU requirements for qualification and validation)
ISO 14644 (cleanroom standards)
This level of rigor verifies that manufacturing processes are not only efficient but also safe for producing medicines, vaccines, biologics, and other life-saving products.
Why Commissioning Matters in Pharma
Pharmaceutical facilities are high-risk environments where mistakes can have consequences ranging from costly delays to patient harm. Commissioning delivers value in several critical ways:
Regulatory Compliance
Commissioning helps pharmaceutical companies demonstrate to regulatory authorities that systems meet GMP standards. Proper documentation reduces the risk of FDA or EMA inspection findings.
Risk Reduction
Through structured testing and verification, commissioning ensures that systems operate reliably and reduces the chance of contamination, equipment failure, or production downtime.
Cost Savings
While commissioning requires upfront investment, it saves money in the long run by preventing rework, product recalls, and compliance penalties.
Operational Readiness
Commissioning verifies systems are ready for qualification and production, accelerating time-to-market for critical drugs.
Patient Safety
Most importantly, commissioning protects end users (the patients) by making sure medicines are produced under the highest quality and safety standards.
Key Stages of Pharmaceutical Commissioning
Commissioning is not a single activity but a structured process. While the details vary by project, most pharmaceutical commissioning programs include the following stages:
Design Review
Confirm that design specifications align with user requirements and GMP guidelines.
Evaluate P&IDs (Piping and Instrumentation Diagrams), layouts, and equipment specifications.
Factory Acceptance Testing (FAT)
Performed at the vendor’s site before equipment shipment.
Ensures equipment functions according to design before delivery.
Installation Verification
Conducted at the facility once equipment arrives.
Includes checks on correct installation, materials of construction, and compliance with engineering drawings.
Operational Testing
Simulates normal and stress conditions to verify equipment reliability.
Involves calibration, alarms, interlocks, and software testing.
Performance Verification
Demonstrates that the equipment operates consistently under process conditions.
Provides the foundation for validation activities.
Documentation and Handover
Comprehensive documentation is prepared, including commissioning protocols, test results, and deviations.
Ensures a smooth transition to qualification and validation teams.
Best Practices in Pharmaceutical Commissioning
To maximize the effectiveness of commissioning, pharmaceutical companies and their commissioning partners should adopt best practices, including:
Early Integration into Project Planning: Commissioning should begin during the design phase, not after construction is complete.
Risk-Based Approach: Focus resources on high-risk systems (e.g., clean utilities, sterile processing equipment) while streamlining lower-risk areas.
Documentation: Maintain traceable, auditable records to support regulatory inspections.
Cross-Functional Collaboration: Engage engineering, quality assurance, operations, and validation teams throughout the process.
Use of Automation and Digital Tools: Modern commissioning management software streamlines documentation, deviation tracking, and reporting.
Types of Systems Commissioned in Pharma
Pharmaceutical commissioning covers a wide range of facility, utility, and equipment systems, including:
Clean Utilities: Purified water, water for injection (WFI), clean steam, compressed gases.
HVAC & Cleanrooms: Verifying ISO-classified environments are particle- and contaminant-controlled.
Process Equipment: Bioreactors, centrifuges, fermenters, isolators, and lyophilizers.
Automation & Control Systems: Distributed Control Systems (DCS), Programmable Logic Controllers (PLC), and SCADA.
Laboratory Instruments: HPLCs, GCs, balances, and other calibrated equipment.
Each category requires tailored commissioning protocols to maintain reliability and compliance.
The Relationship Between Commissioning and Validation
While commissioning and validation are closely related, they serve different purposes:
Commissioning: Confirms that systems are designed, installed, and function as intended.
Qualification/Validation: Provides documented evidence that systems produce consistent results meeting quality standards.
In practice, commissioning activities provide much of the evidence used in qualification, reducing duplication and accelerating the overall CQV process.
Challenges in Pharmaceutical Commissioning
Commissioning in the pharmaceutical industry is not without challenges. Common hurdles include:
Complex Regulations: Navigating overlapping global regulatory requirements.
Evolving Technology: Adapting commissioning strategies for advanced therapies, continuous manufacturing, and digitalized equipment.
Tight Timelines: Meeting aggressive project schedules without compromising quality.
Documentation Overload: Managing thousands of documents while maintaining traceability.
Cross-Functional Alignment: Coordinating multiple stakeholders with different priorities.
Partnering with an experienced commissioning company helps mitigate these risks through proven frameworks and industry expertise.
Benefits of Partnering with a Commissioning Specialist
Choosing the right commissioning partner can make or break a pharmaceutical project. Benefits include:
Expert Knowledge: Specialists understand GMP, global regulations, and risk-based commissioning strategies.
Efficiency: Streamlined processes reduce project delays and costs.
Advanced Tools: Use of digital commissioning platforms improves data integrity and reporting.
End-to-End Support: From design review through validation handover, specialists provide continuity and accountability.
Regulatory Confidence: Properly executed commissioning builds confidence during regulatory inspections.
The Future of Commissioning in Pharma
As the pharmaceutical industry embraces advanced therapies, digitalization, and automation, commissioning will continue to evolve. Key trends include:
Integration of Digital Twins: Using virtual models to simulate and maximize systems before commissioning.
Automation in Documentation: AI-driven platforms reducing manual paperwork.
Sustainability Focus: Commissioning processes that emphasize energy efficiency and environmental responsibility.
Continuous Manufacturing: Requiring adaptive commissioning approaches for non-traditional processes.
Forward-thinking companies that invest in commissioning excellence will be well-positioned to deliver high-quality medicines faster and more cost-effectively.
Let's Wrap it Up!
Commissioning in the pharmaceutical industry is more than a procedural step, it is the backbone of compliance, efficiency, and patient safety. From clean utilities to complex automation systems, commissioning ensures that every system performs as intended and meets stringent regulatory requirements.
For pharmaceutical companies, partnering with a specialized commissioning provider offers peace of mind, reduced risks, and accelerated timelines. As technology advances and regulations tighten, commissioning will remain a vital element in bringing safe, effective medicines to market.
About GL Technologies
GL Technologies, based in San Diego, is a specialized service provider catering to the highly regulated industries of biopharmaceuticals, pharmaceuticals, medical devices, and government sectors. The company focuses on delivering expert solutions in equipment calibration, validation, and compliance services, ensuring that clients meet stringent GMP (Good Manufacturing Practice) and FDA regulations. GL technologies is a trusted partner from commissioning new plants to decommissioning with compliance. GL can place dedicated motivated quality personnel on site anywhere. A program can be designed or revamped for the customers needs from design of CMMS to SOP development, specification development and performance of calibrations.
With a dedicated team of 29 technicians, GL Technologies offers precision calibration, preventative maintenance, and qualification services for laboratory and production equipment used in critical manufacturing and research processes. The company’s expertise is supporting its clients in maintaining regulatory compliance and operational efficiency.
As a full-service company specializing in equipment calibration, repair, and certification services for biopharmaceutical, pharmaceutical, and medical device industries. Our team has extensive experience working with sPRT calibrations along with CMMS software, HPLC OQ validation, and fume hood certifications. Companies of all sizes rely on our team to implement, maintain, and keep their research and manufacturing processes compliant with regulatory standards. Other specialties include building maintenance systems, and mass spectrometry calibrations. GL Tec specializes in IQ OQ PQ services for clients throughout San Diego, San Francisco, Los Angeles, Orange County, and Riverside!