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Notes on Equipment Qualification
Equipment Qualification is the final series of inspections and tests to ensure that critical requirements necessary for related product quality are satisfied and that documents and procedures necessary to properly operate and maintain the system are in place.
Critical requirements may be derived from system User Requirements Specifications, transfer reports and manufacturing instructions.
On this page:
- Examples of Critical Installation Requirements
- Assessment
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Examples of Critical Installation Requirements
Examples of critical installation requirements may include product contact material and instrument accuracy. Examples of critical operating requirements may include temperature and fill weight accuracy. Systems having at least one critical requirement are subject to Equipment Qualification.
Principles of Equipment Qualification (EQ)
The extent of qualification activities will vary depending on the specific function of the equipment being qualified. Equipment may require IQ only, IQ/OQ, or IQ/OQ/PQ. The number and type of specific inspections and tests will be dependent on the complexity of the system & it’s impact on product quality.
Assessment
Assessment of systems should include an evaluation of system components and functions to determine impact on product quality. These should take into account User Requirements, (when available), Critical Process Parameters, (CPPS), and Critical Quality Attributes, (CQAs) related to system use. The intent of these evaluations should be to ensure that appropriate inspections and tests are prescribed for each system element.
Records of assessments should become part of the validation files. They may be included in the Validation Plan or Equipment Qualification Protocols._x000D_
Installation Qualification (IQ)
IQ ensures that the equipment as installed, meets the User Requirements and that critical installation requirements have been verified.
Installation Qualification requirements could include the following: –
Commissioning complete verification
As-built schematic(s) – typically P&Ids
Equipment list – including all system components that are identified by a tag number
Instrument List – including all system instruments identified by tag number
Lubricants list – list lubricants with potential product contact
Software Title, Software Version & Installation Cert
Utility connections – verify utility connections
Instrument calibration records – at IQ stage, these may be factory calibrated
Parts list – verify location of parts list
Operational Qualification (OQ)
Operational Qualification ensures that the equipment as installed meets the User Requirements and that critical operational requirements have been verified.
OQ generally will consist of a test or series of tests designed to challenge critical operating requirements and alarms such as speed, pressure, temperature, flow rate etc, against pre-determined Acceptance Criteria. The duration of the tests should be adequate to ensure system capability to achieve desired performance while experiencing variations that might be expected to occur in normal use._x000D_
The operational ranges of testing should include a set of conditions encompassing upper and lower operating limits._x000D_
Operational Qualification requirements may include:-
IQ Complete – verify IQ completion
Instrument calibration records
Security, alarm & interlock checks
Critical Requirement test
Functional tests
Performance Qualification (PQ)
The purpose of PQ is to qualify the operation of a system of multiple units that may have undergone separate IQ/OQs.
The PQ of critical utilities should involve an extended monitoring and sampling program to demonstrate system performance.
PQ requirements are analogous to the OQ requirements listed above but should focus on integrated system performance.
Velopi can provide customers with the technical and management expertise needed to deliver projects. Either on-site with the customer or off-site; we provide an experienced, flexible & cost effective solution to either short-term or long-term needs. We provide a wide range of services to the Pharmaceutical & Medical Device industry globally.
Contact us for further information on what we can do for your organisation.
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