How to Develop a Commissioning Plan for a New GMP Laboratory
GL Technologies is a premier provider of commissioning services for new GMP laboratories, helping pharmaceutical and biotechnology organizations bring critical facilities, utilities, and equipment into operation.
Building a new Good Manufacturing Practice (GMP) laboratory requires more than purchasing equipment and completing construction. Before the laboratory can reliably support pharmaceutical, biotechnology, or medical-device operations, its facilities, utilities, instruments, computerized systems, and procedures must be shown to perform as intended.
A well-developed laboratory commissioning plan provides the framework for accomplishing this work. It defines what must be tested, who is responsible, how results will be documented, and how the facility will transition from construction into qualified GMP operation.
What Is a GMP Laboratory Commissioning Plan?
A GMP laboratory commissioning plan is a controlled document describing the activities required to verify that a new laboratory has been designed, installed, tested, and prepared for its intended use.
Commissioning typically begins during design and continues through construction, equipment installation, system startup, testing, qualification, and operational handover. It may cover:
Laboratory rooms and controlled environments
Heating, ventilation, and air-conditioning systems
Electrical power and emergency power
Purified water and laboratory gas systems
Environmental monitoring systems
Fume hoods and biosafety cabinets
Cold rooms, refrigerators, freezers, and incubators
Autoclaves and laboratory washers
Analytical instruments
Computerized systems and data infrastructure
Safety systems and emergency equipment
Commissioning and qualification are related, but they are not identical. Commissioning confirms that systems have been properly constructed and function according to design requirements. Qualification provides documented evidence that GMP-critical facilities, utilities, and equipment are suitable for their intended uses.
FDA guidance emphasizes that appropriate facility design, commissioning, and qualification should occur before process performance qualification. The agency also recognizes that qualification may be managed through individual plans or an overall project plan using a risk-based approach. (FDA Process Validation Guidance)
1. Define the Laboratory’s Intended Use
The first step is to clearly define what the laboratory will do. A quality-control chemistry laboratory will have different requirements from a microbiology, research and development, stability, or cell-culture laboratory.
Identify the activities that will occur in each area, including:
Raw-material testing
In-process testing
Finished-product release
Stability studies
Microbiological testing
Sample storage
Analytical method development
Environmental monitoring
The intended use establishes the foundation for user requirements, system classification, risk assessments, acceptance criteria, and qualification activities.
Project teams should involve quality assurance, laboratory operations, engineering, validation, information technology, environmental health and safety, facilities, and equipment vendors. Early collaboration helps prevent critical requirements from being discovered after construction or installation.
2. Establish User Requirements Specifications
User Requirements Specifications, commonly called URSs, describe what each system or piece of equipment must accomplish. Requirements should be clear, testable, traceable, and connected to the system’s intended GMP use.
A URS for an ultra-low-temperature freezer, for example, may define:
Required operating-temperature range
Storage capacity
Temperature uniformity
Alarm functions
Access controls
Backup power requirements
Data-recording capabilities
Calibration requirements
Electronic-record retention
Security and audit-trail expectations
The URS becomes a primary reference throughout design reviews, vendor selection, acceptance testing, commissioning, and qualification. Vague requirements can create testing gaps, change orders, and delays during laboratory startup.
3. Develop a System Inventory and Define Boundaries
Create a complete inventory of the laboratory’s facilities, utilities, equipment, instruments, and computerized systems. Each system should have a unique identifier and clearly defined boundary.
System boundaries establish what is included in each commissioning package. For an HVAC system, the boundary might include air-handling equipment, ductwork, terminal filters, controls, room sensors, alarms, and building-management-system interfaces.
The inventory should also identify supporting systems and dependencies. An analytical instrument may depend on electrical power, laboratory gases, network connectivity, environmental controls, software, and a validated data-storage location.
4. Apply Quality Risk Management
Not every laboratory component requires the same degree of testing or documentation. Conduct a documented risk assessment to determine which systems can directly or indirectly affect product quality, data integrity, personnel safety, or regulatory compliance.
Consider:
Impact on sample identity, strength, quality, or purity
Potential for contamination or cross-contamination
Effect on analytical accuracy
Generation or storage of GMP data
Ability to detect system failures
Impact of utility interruptions
Complexity of system controls
Consequences of malfunction
High-risk systems should receive greater verification and quality oversight. Lower-risk components may be addressed through documented engineering commissioning. Risk assessments should provide defensible reasons for the selected testing strategy rather than being used simply to reduce documentation.
5. Define the Commissioning and Qualification Strategy
The plan should explain how commissioning will connect with Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.
Typical activities include:
Design Qualification: Verifies that the proposed design satisfies approved requirements and GMP needs.
Factory Acceptance Testing: Tests equipment at the manufacturer’s facility before shipment.
Site Acceptance Testing: Confirms condition, installation, and basic functionality after delivery.
Installation Qualification: Verifies installation against approved drawings, specifications, manuals, and requirements.
Operational Qualification: Challenges operating ranges, alarms, controls, interlocks, and failure conditions.
Performance Qualification: Demonstrates consistent performance under actual or simulated routine-use conditions.
FDA’s lifecycle approach calls for facilities, utilities, and equipment to be appropriately designed and qualified before use in regulated operations. (FDA CGMP Regulations)
Where commissioning test results will be leveraged during qualification, this approach should be approved in advance. The documentation must be complete, attributable, reviewed, and executed under suitable controls.
6. Create a Testing and Documentation Matrix
Develop a traceability matrix connecting every critical requirement to a commissioning or qualification test. This helps demonstrate that nothing was overlooked.
Each test protocol should define:
Test objective
Required prerequisites
Test procedure
Acceptance criteria
Required instruments
Data to be recorded
Responsible personnel
Review and approval requirements
Deviation-handling procedures
Test instruments must have current calibration status appropriate for their use. Records should include actual results—not merely indicate that a test passed.
7. Plan for Deviations and Change Control
Issues are common during laboratory commissioning. The plan should define how discrepancies, punch-list items, failed tests, and design changes will be recorded and resolved.
Critical deviations should undergo documented investigation and impact assessment. Corrective actions must be completed before the affected system is released unless a scientifically justified and quality-approved exception is established.
Formal change control is also essential. Equipment substitutions, software updates, revised room layouts, control changes, and utility modifications may affect approved requirements or completed testing.
8. Prepare for Operational Handover
A system should not be released solely because physical testing is finished. Handover requirements may include:
Approved commissioning and qualification reports
Closed critical deviations
Current calibration records
Preventive-maintenance schedules
Approved standard operating procedures
Completed personnel training
Spare-parts recommendations
Vendor manuals and certificates
Final drawings and specifications
Data-integrity and cybersecurity controls
System ownership assignments
Quality assurance should approve the release of GMP-critical systems before routine use.
Build Compliance Into the Laboratory from the Beginning
An effective GMP laboratory commissioning plan creates a controlled path from design through operational readiness. It improves coordination, exposes problems earlier, supports regulatory compliance, and reduces the risk of expensive startup delays.
GL Technologies provides laboratory commissioning, qualification, calibration, validation, and technical support for pharmaceutical and biotechnology facilities. By applying a documented, risk-based approach, organizations can open new GMP laboratories with greater confidence that their critical systems are properly installed, tested, and ready for their intended use.
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!