At Geneire, we offer specialized commissioning, qualification, and validation (CQV) services to the pharmaceutical and biopharmaceutical sectors, ensuring that facilities and systems meet the highest industry standards. Our team of highly experienced CQV engineers brings deep expertise and precision to every stage of the process, from initial commissioning through rigorous qualification and validation protocols. We work closely with clients to ensure compliance with regulatory requirements, including GMP and FDA standards, while delivering operational excellence. By leveraging best practices and cutting-edge methodologies, Geneire provides reliable, efficient, and compliant solutions, enabling our clients to achieve successful project outcomes and maintain confidence in their critical operations.
These services are critical for maintaining compliance with Good Manufacturing Practices (GMP) and other regulatory standards. Below are the key CQV services typically provided in the pharmaceutical sector:
1. Commissioning Services
Commissioning ensures that all systems and equipment are installed and functioning as intended before formal qualification begins.
Pre-commissioning Activities:
- ◆ Vendor document review (manuals, specifications, certifications).
- ◆ Factory Acceptance Testing (FAT).
- ◆ Site Acceptance Testing (SAT).
- ◆ Equipment installation verification.
Static and Dynamic Commissioning:
- ◆ Inspection and testing of mechanical, electrical, and process systems.
- ◆ Verification of instrumentation and control systems.
Functional Testing:
- ◆ Ensuring systems operate according to design parameters.
Documentation:
- ◆ Creation of commissioning protocols and reports.
2. Qualification Services
Qualification confirms that facilities, utilities, and equipment meet predetermined specifications and operate consistently within defined parameters.
Installation Qualification (IQ):
- ◆ Verification of proper installation of systems and equipment per design specifications.
- ◆ Documentation of installed components, including materials of construction, piping, and wiring.
Operational Qualification (OQ):
- ◆ Testing to ensure systems operate as intended under various conditions.
- ◆ Calibration and testing of alarms, controls, and automation systems.
Performance Qualification (PQ):
- ◆ Demonstration that systems perform reliably under real-world operating conditions.
- ◆ Validation of critical parameters such as temperature, humidity, pressure, and flow.
3. Validation Services
Validation ensures that processes, systems, and equipment produce consistent, reliable results that meet regulatory requirements.
Process Validation:
- ◆ Verification that manufacturing processes deliver consistent, reproducible results.
- ◆ Includes three stages: Process Design, Process Qualification, and Continued Process Verification.
Cleaning Validation:
- ◆ Ensuring cleaning procedures effectively remove residues to prevent contamination.
Computer System Validation (CSV):
- ◆ Testing and documentation of computerized systems to ensure data integrity, security, and compliance.
Utility Validation:
- ◆ Qualification of critical utilities, including water systems (e.g., purified water, WFI), clean steam, and HVAC.
Equipment Validation:
- ◆ Validation of manufacturing and laboratory equipment to ensure consistent performance.
By delivering these comprehensive CQV services, our pharmaceutical customers can ensure that their operations meet regulatory standards, minimize risks, and maintain consistent product quality.