We guide clients through the entire commissioning and qualification process for bespoke skids and systems. We ensure your facility is in line with your requirements, risk free and ready for production.
In the context of pharmaceutical process engineering, commissioning and validation are two critical processes that ensure pharmaceutical manufacturing facilities, equipment, and processes meet the required quality and regulatory standards. Both commissioning and validation are essential steps in assuring the safety, efficacy, and quality of pharmaceutical products.
Commissioning is the systematic process of verifying and documenting that all systems and components of a pharmaceutical manufacturing facility or equipment are designed, installed, tested, operated, and maintained according to the intended design and operational requirements. The primary goal of commissioning is to ensure that the facility and equipment are fully functional, reliable, and capable of consistently producing high-quality pharmaceutical products. The commissioning process typically includes the following steps:
Design Qualification (DQ):
This step involves verifying that the design of the facility or equipment meets the intended requirements, regulations, and quality standards.
Installation Qualification (IQ):
During IQ, the installation of equipment and systems is verified to ensure that they are correctly installed and integrated as per the design specifications.
Operational Qualification (OQ):
OQ focuses on testing the equipment and systems to ensure they perform as intended under operational conditions. This involves testing various operating parameters and ranges.
Performance Qualification (PQ):
PQ is the final step in commissioning, where the equipment or system is tested under simulated or actual production conditions to demonstrate that it consistently produces the desired quality output.
Validation is the process of establishing documented evidence that a pharmaceutical manufacturing process consistently produces products meeting predetermined quality specifications. The validation process is critical to ensure that pharmaceutical products are safe, effective, and meet regulatory requirements. Validation encompasses a broader scope than commissioning and involves the validation of all critical processes, not just equipment. The main types of validation in pharmaceutical process engineering are:
Process Validation:
This involves validating the manufacturing processes used to produce pharmaceutical products. It includes three stages: prospective validation (before routine production), concurrent validation (during initial production), and retrospective validation (after routine production begins).
Cleaning Validation:
Cleaning validation ensures that equipment used in pharmaceutical manufacturing is adequately cleaned to prevent cross-contamination and ensure product purity.
Analytical Method Validation:
This type of validation ensures that the analytical methods used to test and analyse pharmaceutical products are accurate, reliable, and suitable for their intended purpose.
Computer System Validation:
In the modern pharmaceutical industry, computerised systems used for manufacturing, data management, and quality control are validated to ensure their accuracy, reliability, and security.
Both commissioning and validation are essential steps in pharmaceutical process engineering to guarantee the quality, safety, and compliance of pharmaceutical products. These processes help pharmaceutical companies adhere to regulatory requirements and maintain the highest standards of product quality throughout the manufacturing lifecycle.
Overall, field services are a crucial component of a process engineering company’s offerings. They bridge the gap between engineering design and real-world implementation, ensuring that clients’ process equipment and systems are functioning optimally, compliant with regulations, and aligned with industry best practices. The provision of field services enhances customer satisfaction, minimises downtime, and contributes to the long-term success of the process engineering projects.
Learn more about our customised solutions and how we can help your business grow and thrive with our project delivery focus and bespoke process systems.