The purpose of this operational qualification (OQ) is to provide documented evidence that the functions of the freeze-drying unit adhere to the appropriate codes and approved design intentions and current good manufacturing and engineering practices. The OQ provides documented evidence that the system performs as intended throughout all anticipated operating ranges.
It contains the procedures to verify specific dynamic attributes of a system or piece of equipment throughout its operating range, which may include “worst case” conditions. Completion of the 00 and sign-off by the user. Confirms conformity with the design specifications and authorizes the start of Performance Qualification (PQ).
Scope of Operational Qualification
This document focuses on the OQ of the freeze-drying unit, covering process sequences and control system functionalities, including both PLC and PC components. Testing will be executed by qualified personnel and includes a wide range of functional verifications.
For a deeper understanding of system performance evaluation, we recommend reading our article on Freeze Dryer Performance Testing Methodology.
For readers seeking to understand the intricacies of lyophilization processes and common equipment troubleshooting, check out our guide on Troubleshooting Failure in Condenser Refrigeration System in Freeze-Dryers.
Responsibilities
- Verify that the system is properly operating
- Write the protocol.
- Execute the tests
- Document and resolve deviations
- Write 00 Summary Report
- Approve the protocol
- Review OQ test result
- Review and approve OQ Summary Report
OQ, FAT, SAT, and Commissioning Report
Lyophilizer internal testing and commissioning phase will be performed prior to FAT. This includes a comprehensive testing of the system functionality. In general, the tests will only be documented for internal use. To reduce test time and project lead time, it is suggested to combine the commissioning tests and the IQ tests as far as possible to avoid redundant testing. Tests that are related to the design and will not be affected by the disassembly of the equipment (e.g., password test, operator error, condenser capacity) may be performed at only one. Relevant tests have to be commonly agreed during FAT
Design-related tests such as the Functional Test of the Freeze-Drying Process and Clean in Place (CIP) in Freeze-Drying can often be performed without equipment disassembly, provided both parties agree during FAT.
Summary Report: This conclusion provides an overview and summary of all OQ activities. It will include a list of deviations.
Acceptance Criteria
For successful qualification, all test procedures must be successfully completed. All acceptance criteria for individual tests are considered acceptable. All attachments to the OQ tests must be complete and enclosed. An observation report must be issued whenever the acceptance criteria are not fulfilled. All observation reports must be closed. If observation reports remain open at the end of OQ testing,
All observation reports must be closed before initiating PQ. If not, their status must be documented along with an evaluation.
Freeze dryer Operational Qualification Protocol Overview
Key Components of OQ Testing Electrical & Functional Tests
- Functional Test of the Freeze Drying Process and Stoppering System
- Functional Test of the Defrosting Process
- Functional Test of the Sterilization (SIP) Process
- Functional Test of the Clean in Place (CIP) Process
- Functional Test of the Filter Integrity Test (WIT) Process
- Functional Test of the Media Fill Process
- Functional Test of the Unit Test Process
- Check of the Emergency Functions
- Functional Test of Process and Failure Messages
- Functional Test of the Door Opening System
- Check the System Against Operation Error
- Functional Test of Password Protection
- Verification of Audit Trail Functionality
- Verification of Screen Layouts
- Verification of Batch Report
Acceptance Test result: All result must be pass
Explore more about maintaining critical components like the Compressor Motor Jacket Cleaning and Filter Drier Cylinder for optimal system performance.
Summary Report of Operational Qualification
The OQ Summary Report consolidates all findings and test results, including deviations and their resolution status. It concludes whether the system is suitable to move forward with Performance Qualification (PQ).
To understand the bigger picture of quality assurance, explore related concepts like extractables and leachables in freeze-drying systems.
Conclusion of Operational Qualification
The Operational Qualification Protocol ensures that freeze-drying systems operate within defined and controlled limits. It bridges the gap between system installation and performance validation, playing a crucial role in product safety and quality. An effectively executed OQ not only meets compliance standards but also guarantees operational excellence in pharmaceutical manufacturing.
FAQs of Operational Qualification
What is the main goal of Operational Qualification (OQ)?
OQ verifies that equipment performs according to its design specifications and meets regulatory standards across its full operational range.
Why is OQ important before Performance Qualification (PQ)?
OQ provides the evidence needed to ensure the system is ready for PQ. Without a completed OQ, PQ cannot begin.