Operational Qualifications

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

The validation process is subject to the following design specifications, user and performance requirements, preparation of a master plan/validation protocol (installation qualification, operational qualification, and performance qualification), execution of the protocol, preparation of a summary report, and on-going validation (and revalidation if changes are made). 

Thus, while a well-maintained instrument is important for any chemical/physical measurement, in NIR, without a concurrent standard for comparison, it is critical that the instrument be continuously calibrated and maintained. Since the major manufacturers of equipment have worked with the pharmaceutical industry, this has been formalized into what is called IQ/OQ/PQ, or Instrument Qualification, Operational Qualification, and Performance Qualification. The first is routinely performed (at first) by the manufacturer in the lab/process location, the second in situ by the user with help from the manufacturer, and the third is product/use dependent. These formal tests apply to all instruments in any industry. 

Instrument qualifications are the tests that are performed after the equipment is installed for use in a laboratory. Instrument qualifications include installation qualification, operational qualification, and performance qualification. These tests verify that the equipment is installed, operates, and performs according to the manufacturer s specifications. Each of these types of qualifications is defined in more detail in the following sections. 

Indeed, the need for capital investment in a CMO may not have been originally anticipated or planned for and may impact on the whole decision making process. Additional costs and time need to be set aside for training and equipment validation, e.g. PQ/IQ/OQ (process qualification/ installation qualification/ operational qualification), and if this includes equipment with radically different operating principles than currently available on site then additional costs will be required for equipment-specific operating personnel and training. 

Instrument qualification or validation refers to the process of demonstrating an instrument s suitability for its intended use. The first step is to write protocols to cover the four main qualification elements design qualification, installation qualification, operational qualification, and performance qualification. Another qualification element, re-qualification, can be written as a separate protocol or included as part of the PQ protocol. These protocols must be performed in sequence. If the protocol meets its acceptance criteria, then the next protocol in the sequence can be executed. 

EMSC extended multiplicative signal IQ/OQ/PQ installation qualification/operation... 

Equipment validation comprises installation qualification, operational qualification, and performance qualification. The intention is to demonstrate that equipment is qualified for processing. 

The system consists of an oil-free compressor, drier, storage tank, and distribution system. The validation process consists of installation qualification, operational qualifications, and actual validation testing of the operational system. 

The documentation (installation qualification, operational qualification, etc.) established prior to initiating validation studies provides the foundation for the subsequent validation. A comprehensive steam sterilization protocol should include the following items ... 

Steam sterilization validation. All autoclave operations conform to the Master Validation Plan employed at ABC Pharmaceutical Industries. The autoclave has undergone installation qualification, operational qualification, and performance qualification. The autoclave is revalidated on an annual basis. The equipment steam sterilization cycle revalidation data for the autoclave are provided in validated archives. 

When new equipment is purchased or there is a change in the manufacturing site, qualification exercises are performed as part of the validation process. Qualification (installation qualification, operation qualification, and performance qualification) for any equipment or facility is an extreme process which involves testing, verification, and documentation to assure that the particular equipment or facility is per the specification and meets the appropriate standards as defined by vendor and required by manufacturing and engineering personnel [14]. 

Operational Qualification Operational qualification provides documented evidence that the instrument will perform in accordance with its functional requirements throughout the representative operation range in a suitable environment. The OQ for simple instruments such as pH meters, balances, stirrers, water baths, and thermometers can simply achieved by execution of a calibration for the instrument. For moderately complex systems, OQ verifies the correct operation of the hardware and software for the instrument. 

Equipment System Validation The GMP has special features regarding the equipment, setting several points for the validation, such as design qualification, installation qualification, operational qualification, and performance qualification. Each point must be given in a different document, so four documents must be generated for each equipment. Without any of these documents, the equipment cannot be considered adequate for GMP purposes. GMPs do not refer equipment validations nonetheless, they refer these four items, and therefore, equipment can only be considered validated after the approval of these four documents. 

Operation Qualification. Operation qualification (OQ) is the process of establishing that the instrument or system modules operate according to the functional requirements in a suitable environment. For an HPLC system, operation of the pump, injector, and detector will be tested at this stage. Typical OQ tests for HPLC modules and a UV-Vis spectrophotometer are as follows ... 

It is essential that an environmental chamber be qualified at its intended range of use prior to commissioning for routine operation in a stability program. A qualification protocol should be prepared describing the qualification procedures and must include predefined acceptance criteria for successful qualification. The qualification consists of three components an installation qualification, operation qualification, and performance qualification. 

Scale-up ensuring that installation qualification, operational qualification, performance qualification (IQ/OQ/PQ) activities are properly conducted These include cleaning validation, process validation, sterilization validation, and so forth, according to established corporate procedures. 

With the completion of the installation qualification, operation qualification and performance qualification, the equipment is considered qualified and process validation can proceed. A master validation plan should be developed that... 

Design Qualification Installation Qualification Operational Qualification and Performance Qualification... 

Performance qualification, which includes the equipment qualification operated under loaded conditions. Performance qualification is carried out with individual equipment based on the information obtained in efficiency trials prior to process validation under the complete assembled condition. In the case of environmental qualification and utility qualification, performance qualification is generally carried out under the operating condition for 1 year to confirm there is no deviation by season. 

Installation qualification Operational qualification Cleaning validation Ranging studies PLC qualification Process validation... 

Installation qualification, operational qualification, and preventive maintenance of instruments—Since laboratory instruments will be used to determine the actual data that will prove the acceptability of the clean-... 

Definition of Process and Systems Process R D - Installation Qualification Operational Qualification Prospective Performance Qualification i IMb Commercial Production... 

Beyond the ROI issues, one of the premises for the use of advanced process analyzers is improved product quality. For many industries, and in particular industries close to consumers, there is the need to define procedures and installation qualification/oper-ational qualification/performance qualification (IQ/OQ/PQ) issues, good laboratory practice and good manufacturing practice (GLP/GMP), audit trails, etc. Such requirements open the door for the use of improved analytical methodology, which can be readily provided by the implementation of good process analyzer technology. 

Operating Mannals need to be formally reviewed as fit for purpose by the supplier as they form the basis of User Procedures and User Qualification. Operating Manuals must be kept up to date with developments to the compnter systems to which they relate, and they mnst refer to specific hardware models and software versions making up the computer system being snpplied. Recommended ways of working defined by the snpplier should be verified as part of the development testing. 

Installation Qualification Operational Qualification Performance Qualification Operation and Maintenance Prerequisites Validation (Summary) Report... 

User Requirements Specification Functional Specification Configuration Details Design Review Installation Qualification Operational Qualification Performance Qualification Validation Report Change Control... 

Macro, spreadsheet calculations. Installation Qualification, Operational Qualification. 

Equipment maintenance and qualification (installation qualification/ operation qualification/performance qualification)... 

Validation master plan Specification Risk analysis Design qualification Installation qualification Operational qualification Performance qualification Validation report Process validation plan Process validation program Cleaning validation plan Cleaning validation program Computer validation plan... 

Specification qualification, design qualification, installation qualification, operational qualification and... 

HCF Operators demonstrate technical proficiency through written, oral, and practical OJT tests and/or demonstrations. In addition to initial qualification, operators must requalify on a two-year cycle. Records showing progress (including written test results) is maintained for each HCF... 

---