Providing IQ, OQ, PQ Expertise and Execution
At cGMP Consulting Inc., we leverage decades of qualification experience with leading pharmaceutical companies to help you achieve regulatory compliance, tailored to your specific needs—while upholding the highest standards of quality and product safety.
Installation Qualification, Operational Qualification, and Performance Qualification (IQ, OQ, PQ) are key components of the facilities, utilities, and equipment qualification process and ensure that they are properly installed, function correctly, and perform as intended to maintain compliance with cGMP regulations.
With over 20 years of experience in large scale qualification projects, we help you meet internal and regulatory expectations while delivering consistent, high-quality results.
Our services focus on:
Facilities Qualification
Ensuring building design and construction, environmental controls, and layouts are appropriate for manufacturing, packaging, and storage locations.
Utilities Qualification
Qualifying critical systems such as HVAC, purified water, steam, nitrogen, and compressed air to support controlled environments.
Equipment Qualification
Verifying that equipment and instrumentation perform consistently and reliably to ensure product quality and data integrity.
Why Facilities, Utilities, and Equipment Qualification Matters
Proper qualification, including IQ, OQ, PQ protocols, are essential for maintaining current Good Manufacturing Practices (cGMP) compliance.
Here’s why:
IQ, OQ, and PQ play a crucial role in preventing contamination, inconsistencies, and equipment failures that could jeopardize product quality. Comprehensive qualification minimizes risks, maintains product integrity, and ultimately safeguards patient health.
Reduce downtime and risks by ensuring reliable systems and verified performance to help ensure product consistency.
Be inspection-ready with thorough validation documentation, robust testing protocols, and compliance-driven record-keeping to meet FDA and cGMP standards.
Our Process
At cGMP Consulting, our structured methodology ensures results-driven qualification.
1
Design Review
- Evaluate current systems for compliance with cGMP and industry standards.
- Identify deficiencies and recommend improvements.
2
Customized Qualification Plan
- Develop tailored validation plans, protocols, and SOPs that meet necessary regulatory requirements and internal guidelines.
- Use a risk-based approach (RBA) to identify and address critical systems and attributes that directly impact product quality, patient safety, and regulatory compliance. This ultimately ensures reliable processes and consistent outcomes.
3
Testing and Deviation Management
- Execute rigorous testing to verify that facilities, utilities, and equipment meet cGMP standards and function as intended.
- Identify, document, and resolve deviations promptly to ensure compliance, minimize risks, and maintain product quality.
4
Comprehensive Documentation Packages
- Deliver structured qualification packages with test protocols, results, and deviation resolutions for seamless review and approval.
- Provide complete validation records and reports to demonstrate regulatory compliance and audit readiness.
5
Validation Reviews and Requalification
- Conduct regular assessments to ensure facilities, utilities, and equipment continue to meet cGMP compliance and operational standards.
- Perform requalification as needed to address changes, prevent compliance gaps, and maintain consistent product quality.
Qualification vs. Validation?
Qualification and validation are essential processes that ensure facilities, utilities, and equipment (FUE) operate consistently and meet regulatory requirements.
Qualification
Qualification refers to a series of steps (IQ, OQ, PQ) that confirm your systems are installed, functioning, and performing as intended.
- Installation Qualification (IQ): Ensures the correct installation of FUE according to design specifications.
- Operational Qualification (OQ): Demonstrates that FUE operates within defined parameters and tolerances.
- Performance Qualification (PQ): This is used to verify that the process design is confirmed to be capable of reproducible commercial manufacturing.
Validation
Validation ensures consistent production of high-quality products.
- Validation aims to enhance operational efficiency and reduce costs while ensuring that regulatory requirements are met.
- Validation doesn’t stop at individual equipment; it extends to the entire manufacturing process, from cleaning systems to computerized systems.
- Maintaining validated processes is critical, especially when changes such as software upgrades, material substitutions, or equipment modifications occur.
Summary
Validation encompasses qualification but extends beyond it. Validation includes activities such as process validation and cleaning validation, which focus on ensuring the entire manufacturing process is validated, not just individual systems. Both qualification and validation are critical for compliance and product quality in regulated industries.
Industries We Serve
Our qualification services are tailored to industries subject to FDA oversight with varying regulatory and quality standards:
Pharmaceuticals
Biotechnology
Medical Devices
Pharmaceuticals
Biotechnology
Medical Devices
Dietary Supplements
Cosmetics
Distribution
Dietary Supplements
Cosmetics
Distribution
We have extensive experience in qualifying critical systems and utilities, including but not limited to the following:
Critical Systems–
Automated Lyo Loading/Unloading (GEA, SKAN, IMA)
Automated Stopper Can/Stopper Vessel Loading (Atec)
Bottle Fillers (Merrill, IMA, Filamatic)
Bottle Unscramblers (Omega)
Cartoners – Blisters, Vials, Syringes, Cases (Dividella, Korber, Marchesini, Korber, Serpa, Uhlmann)
Capping Machine (Syntegon, Bausch and Stroebel)
Case Packers (Serpa, Weber, Uhlmann, ESS, Korber)
Checkweigher (Mettler-Toledo)
Conveyors (Flexline)
Clean Rooms (Lindner, Daldrop)
Component Sterilizers (Syntegon SBM, Belimed)
Containment (Syntegon, SKAN, Franz Zeil)
Crimp Inspection (Seidenader)
Depyrogenation Tunnel (Syntegon, Bausch and Stroebel)
Denester (Groninger)
Electronic Batch Records (ezGMP, PAS-X)
Filling Machine (Syntegon, Bausch and Stroebel)
Filter Integrity Testers (Pall)
Glove Testing Units (Syntegon, SKAN)
Induction Sealers (Enercon)
Labelers – Bottle, Vial, Syringes, Cases (Herma, Markem, Weber, Weiler, Sancoa, Neri)
Leak Testers (Sepha)
Laser Printers (Domino, Weber)
Lyophilizers/Freeze Dryers (GEA, IMA, Hull, Millrock, SP Scientific)
Mixing and Hold Tanks (TKMS)
Palletizers (ESS, Korber)
Pharmaceutical Washing Machines (Amsonic Hamo, Belimed, Getinge, Steris, Fedegari)
Sachet Machines (Marchesini)
SCADA Critical Utilities (Siemens)
SCADA EMS (Siemens)
Semi-Automated Inspection (Seidenader)
Serialization (Antares)
Thermoformers (Uhlmann Packaging Systems)
VHP Transfer Hatch (Franz Ziel)
Vial Washing Machine (Syntegon, Bausch and Stroebel)
Vision Systems (Cognex, Systech)
Weight Booths (Franz Ziel)
Critical Utilities–
Clean Air (Atlas Copco)
Water for Injection (Stainless Fabrication, Enerquip LLC, Alfa Laval)
Clean Nitrogen (AirGas)
Clean Steam (MECO)
Why Choose cGMP Consulting?
With cGMP Consulting, you gain a trusted partner dedicated to ensuring your success. Here’s why clients choose us:
1.
Regulatory Expertise
In-depth understanding of global standards and requirements.
2.
Comprehensive IQ, OQ, PQ Protocols
Customized IQ, OQ, PQ testing for your facilities, utilities, and equipment.
3.
Tailored Solutions
Strategies aligned with your unique operational needs due to our extensive industry experience.
4.
End-to-End Documentation
Complete and audit-ready documentation at every stage.
5.
Risk-Based Approach
Proactively identifying and mitigating risks to ensure compliance and stability.
6.
Full-Service Support
From design review to requalification, we manage your needs every step of the way.
Industry Expertise
Facilities, Utilities, and Equipment Qualification
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