Qualifications, description

The following documents of the manufacturer can be used as part of this qualification Description and instruction manual, installation drawings and - instructions, test and take over-certificates, and soft ware documentation. It is recommended to list and specify all necessary documents and their format in the purchase order, as this reduces time and effort for the buyer as well for the seller. 

Performance qualification Description and periodic check records... 

The responsibilities of personnel and the laboratory s management structure must be clearly defined, by means of organizational charts, job descriptions and curriculum vitae for the personnel who are carrying out the study. There must also be up-to-date records of qualifications and of the training that the staff have received, including any records necessary to show their competence to carry out their work. 

Many of the technical requirements of the Standard are covered in Chapters 4 to 7. The analytical requirements, including choosing a method and method validation, are covered in Chapter 4. The other measurement requirements, such as calibration, traceability and equipment qualification, are dealt with in Chapter 5. Some of the general issues not covered elsewhere are mentioned in the following sections. It has already been mentioned that staff should be trained and proven to be competent to carry out the testing. This applies to permanent and contracted staff. The laboratory should have a job description for all members of staff. There are more stringent requirements on staff who are also able to provide customers with opinions or interpretation of the results. 

During operation qualification, all components of the instrument are tested individually along with integral parts of the overall instrumentation. In this section, results of some of the most common performance parameters are presented with a brief description of the methods used for evaluation. 

Validation of automated systems must demonstrate a lack of contamination or interference that might result from automated transfer, cleaning, or solution preparations procedures. Equivalency between the results generated from the manual method and the data generated from the automated system should be demonstrated. Since sensitivity to automated dissolution testing may be formulation related, qualification and validation of automated dissolution equipment needs to be established on a product-by-product basis (8,13) (see also Chapter 12 for a more detailed description of automation issues). 

Personnel qualifications for high-complexity testing are stated in the CLIA-88 regulations. The director of the laboratory must be a qualified physician or a doctoral-level clinical scientist. Detailed job descriptions are required as well... 

Records of qualifications, job descriptions, training and experience of personnel are maintained... 

Product Acceptance. Propellant furnished accdg to this document shall be inspected for quality in accordance with qualification and acceptance inspection requirements, outlined under Quality Assurance Provisions, items 4.1, 4.1.1, 4.1.2 and 4,1.3 (not included in our description)... 

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. 

Operational Qualification The OQ document certifies that the equipment works as desired and defined by the manufacturer and the purchaser. An example is the acquisition of a new high-shear mixer/granulator where the paddle is put on rotation with a real calibrated rotation speed tester and, if the value obtained meets the specifications, the mixer paddle rotation passes the OQ test. If not, additional requalification must be performed. All the test results must be introduced and verified in the OQ report that is approved by the company at the end. The OQ document must describe several tests and related specifications to perform on the equipment in order to evaluate if it is working well, and the test to be performed must be described and approved by the manufacturer and the purchaser. Therefore, tests must be performed on the equipment, and for each one a description and signature of who performed and verified the test are required. Usually the tests are performed by the manufacturer and verified by the purchaser. These tests usually consist of evaluating if the mechanical and electric components of the equipment are working as desired. 

Qualification or validation begins with a protocol or plan that describes fully the approach, including the scope, description of equipment, utilities, test methods, acceptance criteria, etc. The approved protocol is then executed by performing the requisite number of replicates as specified in the protocol and gathering the indicated data. The final step is the preparation and approval of a report containing the findings of the activity against the acceptance criteria found in the protocol. 

When reading job descriptions or help-wanted ads, pay careful attention to the wording used to describe the employer s requirements. As you customize your resume for a specific employer, coordinate what the employer is looking for with your own qualifications as closely as possible. Try to use the wording provided by the employer within the ad or job description. 

Once the manufacturing projection questions have been answered, a manufacturing philosophy must be decided on. This includes deciding on documentation requirements, special materials handling, controlled substance security, cleaning validation criteria, and equipment and facility qualification requirements. Now that we know what types of batches are to be manufactured, we can be more detailed in the description of the requirements of the facility. These requirements may be based on internal as well as regulatory requirements. In fact, if a full-scale facility is already in place, this step can be completed fairly easily and quickly. Many of the policies and systems may be transferred directly into the pilot facility. And others may be transferred with only slight modifications. 

This qualitative description only holds strictly in the limit e - 0. Given this qualification, however, we can use the condition for a unique stationary-state... 

The Installation Qualification consists of a description of the lyophilization equipment, a system hardware and component list, the documentation of the installation procedures, and the equipment start-up and operator training. The IQ also includes references to the purchase specifications, engineering review, and SOPs. The objectives are to assure that the equipment design and construction are appropriate for the intended use, it is installed properly, the utilities are suitable and adequate, and that procedures are in place for proper maintenance and operation. 

The PQ is the phase in which either a technical system is tested over a long period of time (e.g., water system), or a complex technical system is tested overall (connected filling line). For many systems OQ is the last phase performed during qualification. If there are only a few performance tests needed, it might be more practical to include them during OQ or process validation. Combining OQ and PQ decreases the number of documents (less documentation work in the future) and cuts approval time and effort. Again, the procedure for PQ is the same as for IQ and OQ ([develop PQ protocols, approve PQ protocols (by the quality assurance, production, and technical departments), perform PQ, work out the PQ report, and approve the PQ report (by the quality assurance, production, and technical departments)]. The documentation and test description are identical to those in the OQ phase. 

Most environmental laboratories have a Statement of Qualifications (SOQ) document that establishes the laboratory s qualifications through descriptions of project experience, a list of accreditations, and resumes of laboratory staff. A review of the SOQ together with the Laboratory QA Manual will enable us to establish the technical capabilities and the capacity of each laboratory (Step 6). Applicable accreditations should be verified as part of laboratory qualifications, such as the state and DOD certifications or approvals. 

Internal customer contact External customer contact Creation/revision date Job description summary Essential duties and responsibilities Supervisory responsibilities Qualification requirements Education and/or experience Language skills Mathematical skills Reasoning ability... 

The facility should ensure record(s) maintenance of the qualifications, training, experience, and job description for each professional and technical individual. 

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