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IQ/OQ documentation details
Installation Qualification (IQ)
The IQ documents consist of printed forms and detailed test protocols, which verify that the correct components are installed and that all installations are according to specifications. Verification of the system documentation is also included, as are descriptions of the software and hardware components of UNICORN™ or BioProCon, necessary for validation of the control system.
Operational Qualification (OQ)
The OQ documents contain tests and acceptance criteria for all components in the system. The tests address the components both as stand-alone and as parts of the system. All analogue (measured values) and digital (on-off) signals are verified. Alarms, warnings, baseline and peak detection functions are verified. Tests of the security system and Audit Trail functions are included.
IQ/OQ binder contents in detail
A typical BioProcess system IQ/OQ binder consists of 300-400 pages, depending on system complexity and instrumentation. The binder is divided into sections based on the components and logic in the system. For a BioProcess system this means:
- IQ part 1 - Computer and UNICORN control system
- IQ part 2 - Electric components and instruments
- IQ part 3 - Liquid handling system
- IQ part 4 - System support information*
- OQ part 1 - Computer and UNICORN control system
- OQ part 2 - BioProcess system equipment
- OQ part 3 - Pre-PQ verifications*
Each section contains the following:
- Cover page
- Initial Approval**
- Final Approval
- Implementation Authorization
- Information texts
- Tests & verifications
- Help/information texts
- Attachments (printouts or additional information obtained)
* To be filled in by the pharmaceutical producer. The system support information is designed to help maintain records of where, for example, manuals, diskettes, CDs, documentation, etc, are stored; the Pre-PQ verification addresses the verification necessary before initiating the Performance/Process Qualification (PQ).
** Before the IQ/OQ work can start each section of the IQ/OQ binder must be signed by the pharmaceutical producer. This signature is necessary to approve binder contents, tests and acceptance criteria. |
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