Formal qualification testing

Unit testing is the testing of the smaller identifiable software components (units). Integration testing is performed to demonstrate that units and higher-level components of the system work together. Formal qualification testing is another term for validation and is performed to formally demonstrate that the software meets its established requirements. 

Following the completion of application testing, the formal qualification testing process begins. 

It is extremely important if timing and budget permit to perform a trial study on any test condition referenced in the OQ or PQ documents. This is especially true for major pieces of equipment, such as a mixer or coater. The reasoning is that if a test condition cannot be achieved during formal qualification, a deviation and an explanation will be required, thereby increasing the documentation requirements. 

It should be recognized that qualification activities need to be undertaken to detailed test procedures that provide comprehensive test records, with all documentation formally reviewed and approved by a designated level of management from the pharmaceutical manufacturer. With this in mind, suitably trained qualification test personnel will be required. 

During qualification testing there may be instances in which the acceptance criteria for a particular qualification verification or test is not met. This must be identified (usually as a deviation) and the corrective action recorded, complete with plans for any retesting that may be required. The implementation of any resulting corrective action must be formally documented and test reruns approved and allocated a new test run number. 

Each qualification must be formally reported to ensure an approved and audit-able transition to subsequent life-cycle phases. Qualification summary reports for the system must be prepared by the pharmaceutical manufacturer and should be kept in the validation file. Each qualification report should confirm the qualification test acceptance and review associated change control records. The report must present a documented record that clearly states the basis for concluding that the qualification is acceptable, particularly if there are any minor conditions or actions outstanding. 

All computer systems performing regulated operations must be validated. To support computer systems validation, the custom-built system must be validated. The SLC must incorporate a formal development methodology with multiple inspections of the supplier s development and associate testing activities and qualification testing. 

Once the protocols have been completed, the test results and data need to be formally evaluated. The written evaluation needs to be presented clearly, in a manner that can be readily understood. The report should also address any nonconformances or deviations to the validation plan encountered during the qualification and their resolutions. The format of the report should be similar to the structure of the associated protocols. The qualification testing should be linked with the acceptance criteria in the relevant specification deliverable, so that the PQ will link with the requirements specification deliverable the OQ will link with the company system specification deliverable and the IQ will link with the technical design specification deliverable. 

Many firms rely on a C of A supplied by the supplier in lieu of actually performing required testing. This becomes a more proactive means of assuring the quality of the material. Acceptance of a C of A is possible after a partnership is established with the supplier through a formal qualification and evaluation of the supplier s capabilities and reliability. Typically the process involves an initial questionnaire, followed by an audit by trained auditors and purchasing representatives. This helps determine if the supplier is qualified to produce the material consistently and in accordance with the firm s expectations. The material then needs to be approved for use in the manufacturing process this is typically done with three distinct... 

The IQ- and OQ-tests may be performed by, or in cooperation with the supplier the formal qualification is the responsibility of the user. 

However, the formal proof of capability to produce quality of the companies involved and as precise a description as possible of the requirements and conditions of the constmction project is not sufficient to succeed with the constmction project. Those involved must also not only have the formal qualifications but also the capability, i.e. specialist knowledge, experience and availability of specialists, machines and equipment, to meet the project requirements Accreditation procedures and voluntarily certification associations offer the possibility that both testing and inspection bodies, which are involved in the context of qualify assurance, and the companies involved in constmction work can prove their specialist competence. 

The procedure can be used to verify the performance of data systems for formal acceptance testing, operational qualification, or requalification ... 

Verbal or written examination of an individual s knowledge of safety functions and various items of equipment, including formal qualifications or tests... 

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. 

The physicians on the university faculty were not happy to see Paracelsus made a professor without their consent. So they insisted that a colloquy, a public test of the new professor s qualifications, be held. Under ordinary circumstances, a colloquy was only a formality but not this time, as Paracelsus realized when he discovered that Dr. Hock had come from Strasbourg to debate him. In the end, Paracelsus simply did not show up for the colloquy. He and his allies on the town council contended that because the council had created the position, the appointment did not have to be validated by the university. The university countered that because it had not been allowed to confirm Paracelsus s appointment, it did not have to extend any academic privileges to him. 

Design qualification is a formal and systematic verification that the computer system requirements specification is met by succeeding system design specifications and their implementation throughout the development and build (including development testing) activities. 

The contents of the FAT, SAT, and OQ tests are similar. The differences between these activities are the test environment and the formality of the testing. Figure E-2 depicts an example of a qualification timeline that contains these activities. FAT, SAT, and OQ are described in Chapter 10. The successful execution of the protocols provides... 

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. 

This is where the hnal version the software is tested, through structural testing and functional/stress testing prior to releasing the LIMS instance for use in the production enviromnent. This environment will be strictly controlled and will only be used for validation and qualification activities. The environment, hardware, software, data and configuration should be an accurate representation of the production environment. Testing should be in accordance with good IT practices and formally documented. 

Standard Operating Procedures (SOPs) must be written to cover operational activities. The SOPs should be written by personnel knowledgeable in the low-level detail of LIMS, and should be detailed enough for the user to work without reference to other personnel or documentation, or memory. By using the OQ as a means of formally testing the SOPs, any issues of detail should be identified. The first version of the SOPs must be authorized and issued prior to the start of Performance Qualification (PQ). 

FAT is the nsnal point at which Client testing commences this shonld be a confirmation exercise rather than a debngging activity. FAT can be nsed as part of the formal system qualification, but where this is the case, testing shonld be performed against predetermined specifications and under controlled conditions. Test specifications shonld be prepared in accordance with GAMP 4 and all resnlts, and wherever possible evidence (e.g., screen dumps, alarm/event printouts, etc.) recorded and collected. 

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