Qualification documentation

If one or more of the following data are not supplied by the manufacturer, it is recommended to measure and to include them in the qualification document of the plants ... 

The goal here is to summarize the installation qualification document. This includes ... 

Performance qualification documents shall include a paragraph stating the objective of the document and a paragraph specifying the scope of the document, i.e., the exhaustive list of the concerned equipment, or categories of equipment. 

All the equipment qualification documents must define the equipment designation, tests to be performed, test specifications, materials, operators, reviewers, and responsibility for approval. 

Design qualification document consisting of user requirement specifications (URS) and functional specifications (FS) [URS and FS can be combined into one system requirement specifications document (SRS)]... 

Installation qualification document (For computer systems, this should include an installation verification test report)... 

Qualification documentation Documentation that must be present and on file before executing the remaining sections of the IQ protocol... 

Definition documentation Design/development documentation Qualification documentation Ongoing evaluation documentation System software System hardware... 

Equipment—proper design and sizes for the project, use and cleaning records, documentation to show proper installation and operational qualification (equipment qualification EQ), and in some cases performance qualification documents, validated computer systems, preventive maintenance program, records of equipment repairs and upgrades and subsequent requalification documentation, etc. 

Hardware configuration diagrams must be retained as part of the qualification documentation. This is especially important in certain laboratory and shop floor situations where the computer hardware is essential to the operation of the equipment. 

The impact of new versions of firmware and software on the validity of the existing qualification documentation should be reviewed and appropriate action taken. If applicable, after the new version is installed, regression testing should be conducted. The results of the regression test must be documented and approved by the appropriate personnel. 

Traditionally, the qualification documents described above contain both specification information and instructions on testing. 

The same equipment and utilities qualification efforts can serve to facilitate the maintenance of said equipment, because of the availability of well-structured, concise, and meaningful qualification documentation coupled with monitoring data. 

The inspection reports that the documents reviewed did not define the system as being validated but was a qualification document. [FDA Wanting Letter, 2001]... 

The tests will be broken into Hardware Acceptance Tests (or Installation Qualification), System Acceptance Tests (or Operational Qualihcation), and Equipment Tests (or Performance Qualihca-tion). According to the size of the unit, all tests may be in one test document or there may be three separate Qualification documents. A test document will define the test philosophy and how the tests should be run. Each test will have a tide, a reason for the test, an oudine of any test equipment required, a description of the test, data to be recorded, and the test acceptance criteria. Calibrated test equipment must be supported with cahbration certificates. 

Submit Performance Qualification Document to QA for review and approval. 

Accreditation is a term that should not be used for PM models. The same criticisms apply to accreditation as to qualification. In addition to the criticisms applied to model qualification, documentation is a further necessary step for model accreditation. Documentation includes verification, which includes assessing the conceptual models and verifying the computer model. The substitution of model accreditation for appropriateness across disciplines could lead to cross-discipline confusion. Therefore, model accreditation should not serve as a substitute for model appropriateness (5). 

Prepare installation report that includes the names and serial numbers of instrument and components, software and firmware versions, actual locations of instrument, manuals, and qualification documentation. Obtain written approval (signatures) from appropriate individuals... 

The general acceptance criteria for the tests during IQ, OQ, and PQ processes are listed in subsequent chapters. Specific acceptance criteria that belong to individual test procedures are listed in each separate qualification document. 

Each qualification document could contain sections/specifications with different version numbers. 

The purpose of a numbering system for the documentation is to ensure an unambiguous identification of each validation/qualification document produced within the field of application of the Validation Master Plan. The document number is a combination of letters and numbers with a length of 10 or 11 characters. An example of such a document number might be ... 

The observations made during the execution of the VMP provide strength to significantly reduce the regulatory risks related to the systems and initiation of the proactive corrective actions required. The plan provides visibility for the completion of individual tasks and assures system evaluation, process validation, equipment validation, facility and utilities qualification, documentation, environmental control, and monitoring implementation and execution of the VMP assures process reproducibility control over the applicable changes and modifications as a result in facilities, equipment, personnel, and materials. 

Operational Qualification Documented verification that the system or subsystem performs as intended over all anticipated operating ranges. 

Installation qualification— Documentation that the equipment was manufactured and installed in accordance with the intended design. This is essentially an audit of the installation against the equipment specifications and facility drawings. 

The first one is simple. Every time the door on the chamber is opened, the conditions inside the chamber will change to some extent (the extent should have been determined during qualification). Documenting that the chamber was accessed is the only action that is required here. 

The validation life cycle is basically split into six main qualification phases as shown in Table 9.2 and all under the control of the Validation Master Plan (VMP). It must be clearly demonstrated that the QA function of the pharmaceutical manufacturer is endorsing the implemented system. In its simplest form, this will require the QA representative to authorize the documentation produced to support validation (e.g., VMP, Source Code Review, qualification documentation, reports, etc.). Table 9.2 shows the linkage between project activities and the qualification process, which is under the control of the VMP. 

In these examples, we are referring to numerous modeling aspects, such as process structures, hierarchical organizations, employee qualification, documents (data), and external or internal output as well as production and IT resources. Obviously, an enterprise model, particularly a business process model for the purpose of optimization, must be fairly complex. Moreover, it should address multiple aspects, for which numerous description methods are necessary. These various purposes determine the kind of modeling objects as well as the required granularity. 

Flow rate. The flow rate accuracy will be determined by the instrument used and will be documented in the supplier s operational qualification documentation. The impact of analyst error made during system setup should be validated and it would be appropriate to investigate the effect of small changes in the region of 10% of the target flow rate. The flow rate may be adjusted by as much as 50%, provided that there are no adverse effects on the chromatography (i.e., resolution, peak shape and retention time). Common causes of flow rate error will be discussed further in Chapter 10. 

Injection volume. The injection volume variation will be determined by the instrument used and will be documented in the supplier s operational qualification documentation. The impact of analyst... 

The qualification documentation shall provide evidence that PDS integrated in hardware components, has been validated to demonstrate that it meets its functional and performance specifications. lEC 60880-2, 4.3.3.2.2 (Cat. A... 

Updating of qualification documentation after modifications and repairs... 

Qualification document development is based upon the use of templates that are customized for particular systems and equipment. The SQPs and SOP govern the use of these templates. 

---