Installation, operational, and performance

To ensure that equipment is fit for its intended purpose, there is a series of qualifying steps that the analyst or vendor should apply to analytical instrumentation (3,4). Equipment can be evaluated through a series of tests or procedures designed to determine if the system meets an established set of specifications governing the accepted operating parameters. The successful completion of such tests justifies that the system operates and performs as expected. There are four components of instrument qualification design, installation, operational, and performance. 

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. 

The manufacturer often creates an instrument qualification plan and provides installation, operational, and performance qualifications to be executed in the customer s laboratory. The company using the equipment must determine if the manufacturer supplied instrument qualifications is comprehensive enough to be sure that the equipment is installed, operating, and performing correctly. If they feel it is not, they may choose to perform more tests themselves. 

To describe the procedure for validation of the freeze drier to ensure it meets the installation, operational, and performance qualihcation criteria... 

To describe the procedure to ensure that the metal check device meets installation, operational, and performance qualihcations to detect metal parts accidentally added into the powder blend during and after sieving... 

FIGURE 1 Validation phases. URS user requirement specification FRS functional requirement specification DQ, IQ, OQ, PQ design, installation, operational, and performance qualifications SOP standard operating procedure. 

Validation protocols are required to describe the objective, methodology, and acceptance criteria for installation, operational, and performance qualifications. They are written to ensure test methods, and acceptance criteria are reviewed and approved before qualification of protocols. In practical terms, there are several stages for the production of protocols. First, an acceptable format needs to be agreed. No universal format exists for protocols, but to some extent, the type of equipment, the size of the project, and the personal preferences will dictate the protocol style. However, some norms have been established. Like other controlled documents, protocols are assigned unique reference numbers and revision numbers. They are titled and numbered on every page and have a particular place for approval signatures. Other common elements in protocols tend to be brief descriptions of the item being qualified and a clear statement of responsibilities. 

Equipment validation is comprised of four critical operations design, installation, operational, and performance qualifications. These operations will confirm that the equipment has adequate specifications, installation, and functions, manufacturing a product with adequate properties. After these procedures, whenever equipment is installed, it must be periodically verified and calibrated in order to ensure adequate performance. 

Instrument qualification is required to establish the functional capability and reliability of a system for its intended use in a suitable environment. Instrument qualification can be divided into three stages installation, operation, and performance qualifications. A qualification protocol that provides details about the system, the scope and constraints of the qualification, qualification tests, test procedures, and acceptance criteria should be available for review and approval before qualification begins. Sufficient time should be provided for review and approval. The protocol should also contain an exception log to record any out-of-specification results, investigation, and problem resolution. 

As noted, excipient manufacture should take place using qualified equipment and a validated process. Generally excipient equipment has been in place for many years so that classical methods of qualification, which is done as new equipment is commissioned, are inapplicable. To retrospectively qualify the installation, operation, and performance of equipment, it is suggested to rely on historical records. For installation and operation qualification, a protocol is prepared that illustrates how maintenance and production records will be used to support the hypothesis that the equipment was installed properly and is operating as intended. Then the protocol is executed by reviewing the maintenance and production records for the supporting data. Finally a report is prepared that includes the data from the records, which support the conclusion that the installation and operation of the equipment conforms to protocol requirements. It is suggested that maintenance and production records for a minimum of one year but preferably five years be reviewed. 

Qualification Verification. Again, the process validation protocol should reference all items that support the validation the procedures, personnel, methods, and equipment. This section therefore lists and summarizes the various installation, operational, and performance/process qualifications completed for the equipment used in the process validation. These qualifications should list each by equipment name and number and qualification and type. A typical verification section is illustrated below. 

Qualification of design, installation, operation, and performance, including monitoring... 

Process validation embraces an entire life cycle beginning in R D, including IQ, OQ, and PQ (installation, operational, and performance qualifications), and ending only when the related product is no longer commercial [6], (An older, now outdated, perception is that process validation starts after IQ and OQ.)... 

The qualification of the configurable elements of the standard product is performed according to normal software installation, operational and performance qualification practices. (Refer to Software Installation Qualification, System Operational Qualification and System Performance Qualification in this chapter.)... 

Assurance that the equipment is properly qualified (i.e., installation, operational, and performance qualified), properly maintained, and currently within calibrated performance ranges (emphasis on scales and balances)... 

User/site acceptance testing of compnterized systems (known as qualihcation) must cover installation, operation, and performance in the wider system context inclnding equipment, processes, and operator interaction (i.e.. Installation Qnalihcation, Operation Qualification, and Performance Qualification). 

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