What is Equipment Qualification?

The Equipment Qualification is the process of proving with a high level of confidence that a device can operate consistently within the limits and tolerances that will be required during the production process.
The qualification concept is part of process validation, but it is focused on studying the fulfillment of technical requirements of each device for the development and implementation of equipment in the Life Science industries.
As with the other components of the production process, the equipment should be qualified following criteria established by current standards (FDA 21 CFR Part 211, item D; Annex 15 of the EU GMP, etc.) and by the company.
Qualifying equipment is an essential part of the commissioning and qualification process in any regulated industry. However, it is important to understand that qualifying equipment does not necessarily mean that you are validating the process itself.
 

Understanding the Difference:

Qualifying Equipment vs. Validating Processes in Regulated Industries

When qualifying equipment, the focus is to ensure that the system functions according to its intended use and meets the defined product and process requirements. This involves testing and evaluating the equipment to ensure it operates within the specified parameters and meets all necessary criteria.

On the other hand, the validation of the process involves confirming that the entire process, including all sensors, measurements, and critical parameters, consistently produces the desired result.

In summary, qualifying equipment ensures it functions as intended, while process validation confirms that the overall system meets all specified requirements and delivers the desired output. Both are essential components of ensuring product quality and compliance in regulated industries.

Lifecycle for ISPE Baseline® Guide: Commissioning and Qualification

The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.

URS:
User Requirements Specifications (URS) combine requirements from multidisciplinary sources to support system design, C&Q, operation, and maintenance. Data sources used to develop the URS may include the product and process development phase, such as Critical Quality Attributes (CQAs), which are key product characteristics essential for quality, and Critical Process Parameters (CPPs), which are variables that should be controlled to ensure the desired product quality. Additionally, product and process requirements, including GMP (Good Manufacturing Practices) regulatory requirements and organizational quality requirements, are considered.
System Classification:
Systems can follow into two categories: direct impact (systems are commissioned and qualified) and not direct impact (systems are commissioned).
C&Q Planning:
Commissioning and Qualification Planning is a planned, documented, and managed engineering activity that starts with the URS and continues to start-up and acceptance and release of systems. The amount of planning, documentation, reporting, and level of detail of the C&Q Plan should be based on expectations of the organization/site, size, and complexity.
System/Functional Risk Assessment:
Examine the quality risk controls for direct impact systems. For a novel system, starting the System Risk Assessment earlier in the design process can be beneficial since this allows for any identified risks to be controlled by design. Most risk control is achieved through system design.
DR/DQ:
Design Review and Design Qualification confirms design meets regulatory requirements and is aligned with the organization's best practices. Verify the design will control risks to product quality and patient safety, as identified during the Risk Assessment.
C&Q Testing Documentation:
• Each organization or project should determine what tests and inspections are needed, when they should occur, and how the records should be documented. Testing activities may be recorded in a single plan or divided into phases such as FAT, SAT, commissioning, and qualification.

• Factory Acceptance Testing (FAT): FAT is conducted at the manufacturer’s site to ensure the system or equipment meets design specifications before delivery.

• Installation Testing: This verifies that the system or its components are installed correctly on-site, meet design requirements, and are ready for start-up. Documentation ensures the installation is complete and meets design expectations.

• Site Acceptance Testing (SAT) and System Start-Up: SAT ensures the system functions as intended at its final location. System start-up involves energizing the system, verifying all mechanical, electrical, and automation functionalities, and ensuring safety compliance. Adjustments, settings, and system balancing are also performed during this phase.

• Operational/Functional Testing: This verifies that the system functions align with approved specifications. Installation and operational testing may be combined in a single document for simplicity.

• Performance Qualification (PQ) Testing: PQ provides documented evidence that the manufacturing system, when integrated with other systems, performs effectively based on the approved process or product specifications. Standard operating procedures (SOPs) should be used during this phase.
Traceability Matrix:
Serves as a tool to identify critical aspects and critical design elements outlined in the Risk Assessment, including their associated results. It ensures traceability for each User Requirements Specification (URS) by linking the requirements to the system design and verifying their implementation through testing.
Acceptance and Release:
Marks the start of the system's "qualified state," initiating processes managed by Quality Assurance (QA). This phase includes implementing Quality Change Control, continuous performance monitoring, and conducting periodic reviews to maintain compliance and system performance.
Final Report:
Concludes the equipment qualification project by summarizing all key activities, results, and outcomes. It should include a clear statement of acceptance, confirming that the equipment meets the predefined requirements and is qualified for use. The report typically contains an overview of the qualification process, references to executed protocols (e.g., IQ, OQ, PQ), a summary of test results, any deviations encountered and their resolutions, and a compliance assessment against regulatory standards. Additionally, it may outline any ongoing requirements, such as maintenance, calibration, or periodic reviews, ensuring the equipment remains qualified throughout its lifecycle.

Simplified Qualification Processes: Plug & Produce for Pharma 4.0

ISPE® (International Society for Pharmaceutical Engineering) and NAMUR (the organization representing users of automation technology in industries like chemicals and pharmaceuticals) are both key organizations in setting standards for automation. NAMUR focuses on helping industries improve automation to meet specific challenges, while ISPE® promotes best practices for making systems efficient and compliant with regulations.

Read more:
ISPE® supports the idea of "Plug & Produce," which allows equipment and modules to be quickly and easily added to existing production systems. This modular approach helps simplify qualification processes, reduce time-to-market, and make production more flexible.

MTP (Module Type Package) plays a critical role in enabling Plug & Produce. MTP is a standardized approach that describes how individual process modules, like mixers or reactors, can be integrated into a larger system. It ensures that these modules can communicate with the overall control system, regardless of the manufacturer.

This standardization reduces the need for custom programming, simplifies system setup, and enhances the flexibility to replace or add modules without major rework. By adopting MTP, companies can better achieve modular and agile manufacturing processes, saving both time and resources.

In December 2024, ISPE® introduced eight key principles for designing systems that align with the Plug & Produce concept. In this model, equipment suppliers pre-validate their components to industry standards. These pre-validated modules, called Process Equipment Assemblies (PEAs), come with full documentation, including requirements, designs, tests, and version history. This allows end-users (like pharmaceutical companies) to treat these modules like off-the-shelf products, requiring minimal additional validation for integration.

End-users are responsible for:

• Ensuring that the equipment communicates correctly with the process's orchestration layer (POL).

• Validating the manufacturing process, ensuring the equipment produces products as required.

This approach helps pharmaceutical companies qualify equipment faster. Existing qualification documentation can often be reused, saving time and effort when integrating new modules or replacing old ones.

Three Main Applications of Modular Plants:

In summary, Plug & Produce simplifies equipment integration, reduces delays, and increases flexibility in pharmaceutical production, making it easier to meet market demands. MTP enhances this by providing a standard that ensures compatibility and easy integration of process modules, further advancing modular and agile manufacturing.

 

If you are a supplier or if you work in the qualification area of a Life Sciences company and need support in preparing qualification documents, please send a message to [email protected]

 

 

Agile Framework in Qualification

 

7x Faster Validation:

Achieve qualification processes seven times faster than traditional methods.

Data Integrity:

Includes electronic signatures at key stages (accessible via tablet or iPad), along with audit trails, strong access controls, and compliance with FDA CFR Part 11 data integrity requirements.

Remote Project Tracking:

Enables online monitoring of project progress from anywhere.

Risk-Based Validation:

Designed to align with FDA and EMA recommendations for risk management.

Audit Responses:

Simplifies audits by allowing access to relevant items within the software, eliminating the hassle of searching through paper records.

Effortless Qualified Status Maintenance:

Avoids the need to re-version all items with every update or change.

Cost Efficiency:

Reduces expenses by eliminating the need for printing and physical storage of documents.

Knowledge Management:

(KM) from pre-built templates.

References:
ISPE. Pharma 4.0 – Toward IT/OT Architectures for Prescriptive Maintenance. Mar,2024.

ISPE Baseline® Guide: Commissioning and Qualification (Second Edition). It is a guide with its intellectual property rights reserved by ISPE. Available for purchase on ispe.org.

BioPhorum. PLUG-AND-PLAY COMPUTERIZED SYSTEMS VALIDATION STRATEGY. Jul,2021.

ISPE® is a registered trademark. All rights reserved. For more details, refer to https://trademarks.justia.com/869/40/ispe-86940969.html