Commissioning and qualification are interrelated processes that ensure facilities, utilities, equipment, and systems used throughout pharmaceutical manufacturing fit their intended purpose.
This blog post provides a basic introduction to commissioning and qualification, with important terms explained. To gain a more comprehensive understanding of commissioning and qualification activities, register for our upcoming webinar, Commissioning and Qualification Best Practices.
What is Commissioning and Qualification?
Whether you are building a new facility or modifying an existing one, commissioning ensures your production processes, systems, and equipment are designed and installed as specified and function as intended. Its primary objective is to satisfy the engineering requirements for all the equipment and systems in a manufacturing facility, creating a safe, functional environment.
Qualification extends beyond commissioning to ensure equipment and systems function to produce products correctly. It is a regulatory requirement that applies to new or existing equipment and systems that directly impact the quality of the product or patient safety. System and component impact assessments and risk assessment tools determine impact.
The ISPE Baseline Guide: Commissioning and Qualification (Second Edition) adjoins the terms commissioning and qualification (C&Q), highlighting the need to unify these activities to increase safety and efficiency.
Commissioning, Qualification and Validation (CQV) in Pharma
A third process — validation — is often associated with commissioning and qualification (commissioning, qualification and validation, or CQV). Validation is a broader concept the FDA describes as "establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes." Validation ensures that the final product is built correctly.
Commissioning can encompass elements of both validation and qualification, with qualification being a subset of the validation process. However, it is essential to note that the individual steps of qualification alone do not constitute validation. For the purposes of this post, we'll limit our discussion to commissioning and qualification.
Commissioning and Qualification Activities (IQ, OQ, PQ)
Equipment installation, data collection, commissioning/validation master plan (VMP) development, system functionality checks, utility verification, and training are just some of the many activities performed during commissioning.
Project teams carry out three distinct types of qualification.
Installation Qualification (IQ):
Installation qualification is a documented process that verifies that the facilities, systems (e.g., mechanical, electrical), utilities, and equipment have been correctly installed and configured to comply with the manufacturer's specifications and approved design. We need documentation to establish a paper trail that proves proper equipment procurement and installation.
Operational Qualification (OQ):
Operational qualification is the next step in quality assurance. It tests to ensure that the installed equipment and ancillary systems can perform reliably within the manufacturer's specified operating ranges. Power, torque, speed, and temperature and pressure controls are essential elements documented during OQ.
Performance Qualification (PQ):
During performance qualification, teams conduct rigorous tests in simulated real-world manufacturing conditions. The objective is to gather comprehensive data and documentation demonstrating the equipment's ability to perform optimally under the required manufacturing conditions. PQ includes process performance qualification (PPQ), which verifies the process performance using production-scale batches.
Other C&Q activities include design qualification (DQ), user requirement specification (URS), and factory/site accepted testing (FAT/SAT).
Regulatory Guidelines for Commissioning and Qualification
Various regulatory bodies, including the European Commission, the Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA), mandate the implementation of C&Q activities. In addition to the ISPE Baseline Guide, commissioning and qualification practices are referenced in the following:
- FDA Process Validation: General Principles and Practices
- Annex 15: Qualification and Validation EU Guidelines
- ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)
- ASTM E 2500 “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”
Why is Commissioning and Qualification So Important?
- Regulatory compliance: Commissioning and qualification are crucial for pharmaceutical companies to ensure compliance with strict regulatory requirements set by agencies such as the FDA, EMA, and others.
- Product quality and safety: Commissioning and qualification ensure that manufacturing processes and equipment meet standards for pharmaceutical production, ensuring excellence, integrity, and safety of the final drug product.
- Operational efficiency: Properly commissioned and qualified equipment and facilities contribute to efficient manufacturing processes. This includes ensuring equipment operates within specified parameters, minimizing downtime, and optimizing production output.
Commissioning and Qualification Challenges
Handling changes using traditional paper-based records like punch lists or engineering change management forms is common during the commissioning and qualification process. However, this manual approach brings about significant challenges, such as:
- Issues with good documentation practice (GDP).
- Increased human error, e.g., data entry mistakes.
- Lost or misplaced records.
- The inability to effectively track and close changes per procedural requirements.
- Poor data integrity.
- Lack of standardization leading to inconsistencies in documentation.
- Delays in bringing products to market.
- Establishing robust audit trails to demonstrate compliance.
- The possibility of releasing unqualified equipment to support GMP operations.
In response to these challenges, many pharmaceutical companies are embracing automated systems. By implementing a digital C&Q solution, organizations can significantly improve accuracy, efficiency, and compliance by minimizing the need for manual protocol execution and documentation. This eliminates the risk of human error and expedites the overall process, allowing companies to bring their products to market faster and with greater confidence.
Register for the Webinar to Learn More
Commissioning and qualification (C&Q) are crucial in ensuring that facilities, systems, utilities, and equipment meet their intended purpose. But, in practice, there is often a noticeable disconnect between "C" and "Q" despite the goal of integration. Our webinar aims to bridge this gap by revealing practical insights and best practices to enhance your understanding and application of C&Q in your projects. Register today to secure your spot.