Qualification, Validation, and Verification

It is important to provide your customer with reliable results that are fit for purpose. As forensic scientists, we look to do this by performing instrument qualifications (calibrations against verified reference materials) and method validations (using verified reference standards), and by ensuring that we apply rigorous system suitability (see Chapter 7) and quality procedures into our methodologies. In relation to HPLC, qualification relates to an assessment of the instrumentation (pump, injector, column compartment, detector) that is used to determine the measured result, whereas validation relates to the applications and methods that are used to generate the results. 

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The terms validation, verification and qualification are frequently used interchangeably. Validation and verification have been defined by EN ISO 8402 1995 [6], Verification Confirmation by examination and provision of objective evidence that the requirements have been fulfilled. 

Lam, H. (2004), Procurement qualification and calibration of laboratory instrument An overview, in Chan et al., Eds., Analytical Method Validation and Instrument Performance Verification, Wiley Interscience, Hoboken, NJ, Chapter 9. 

Installation and operational qualification work includes verification of temperature, pressure, and flow rates, instrument calibration, and thorough flushing of the entire system to remove oil, metal particles, and other contaminants. The type of testing and acceptance limits listed in the validation protocol may vary from firm to firm however, compressed air with product contact should be tested for such quality attributes as hydrocarbons, water vapor, and microbial content (typically less than 0.1 CFU/cu. ft.)... 

The establishment stage includes verification, qualification, and individual validation, including process validation, computer validation, method validation, and cleaning validation. These establishment stage steps shall satisfy the principal requirements in Table 6. 

In practical terms, the verification, qualification, analytical validation, cleaning validation, and process validation need to satisfy certain requirements. 

Design, development, and system build is normally a period of intense activity, in which a supplier will be involved in life-cycle activities and will need to provide a set of auditable design and development documentation to support the validation program. For this, the entire design and development process should be carried out to written and approved procedures, and all design, development, testing, and verification activities should be documented and approved in order to provide a level of computer system documentation that can be used to support the pharmaceutical manufacturer s life-cycle qualification activities. 

Most firms today start by qualifying each subsystem. To qualify, of course, means to establish convincing evidence that something happens as intended, which matches the validation definition (in more explicit terms, however). Installation qualification may be defined as documented verification that all key aspects of the installation adhere to manufacturer s recommendations, appropriate codes, and approved design intentions. Operational qualification is documented verification that a system or subsystem performs as intended throughout all specified operating ranges. 

Performance Qualification (PQ) must be carried out by the user. This is where verification is done to ensure that aU systems work together under as-used conditions to meet the User Requirement Specification. Do room temperature, humidity, and pressure stay in spec with production underway and people entering and leaving the facility AU systems must be operational to complete PQ. Cooperation between the various contractors (mechanical, controls, etc.) is vital to completing PQ in a timely and cost-effective manner. As discussed earlier the user and the designer must sit down at the beginning of the project and determine critical (validated) and noncritical areas. Do not waste resources and money validating noncritical areas. 

Because there is still a misunderstanding of terms such as validation, qualification and verification, these will be explained right at the beginning. It is also important to understand the terms computer system and computerized systems and the different types of software loaded on a computer, but other publications should be consulted for this type of information. 

The system validation documentation includes but is not limited to Quality Assurance Plan (QAP), Operation and Maintenance Manual (O M), and Factory Acceptance Test (FAT) reports. A properly developed QAP and its supporting documentation help to reduce cost, boost product quality, ensure regulatory compliance and increase profitability. The FAT validation is the first verification step of the customer s validation process, which may include design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). 

Obviously, only trained and qualified analysts should be allowed to operate the mass spectrometer. However, in addition to the practical considerations around this topic, an up-to-date record of the qualifications of each analyst should be maintained in the laboratory s facility records, which can be cited as verification that the analyst who performed the analyses in support of the generation of data used to support validation and sample analysis was indeed qualified to do so. 

Equipment Qualification (sometimes referred to as equipment validation) Documented verification that equipment is properly installed, performs as specified throughout operating ranges, and rehably executes desired functions. 

A quality assurance programme is required to be established and implemented to cover items, services and processes that affect safety and are within the scope of this Safety Guide (Ref. [1], paras 3.14-3.16). The quality assurance programme is required to be implemented to ensure that data collection, data processing, studies, analyses and qualification, code validation (software) and verification, and other activities necessary to meet the recommendations of this Safety Guide are performed correctly [11,12]. 

Steps involved in the validation and acceptance of an NIR spectroscopy method, including quality assurance, qualification and verification of instruments, and the International Conference on Harmonization (ICH) guidelines... 

Similar to method validation, it is important to be able to demonstrate that analytical instrumentation is fit for its intended purpose and that it is calibrated and maintained in an appropriate state of readiness. The verification of instrument qualification (see Chapter 8)... 

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]. 

The medical devices for category 3 in Table 1 are constituted (assembled) at the user site. Method verification for constitution should be one of the key factors, as well as qualification and validation in the manufacture of components (parts). Nuclear magnetic resonance spectroscopy (NMR) is included in this category. 

The protocol must include the clarified purpose of each item, such as design verification and installation qualification. For example, the purpose of cleaning validation is to avoid any contamination. 

To achieve appropriate verification, qualification, and individual validation, the method to perform shall be established and the acceptance criteria shall be clarified in the document. 

In the beginning it should be clear what the key issues are for verification, qualification, and process validation. Such issues are listed in Table 7. 

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