Quality systems validated testing procedures

However, the whole of this training and experience should not simply cover the Quality Assurance work only, but the Quality Assurance personnel should also be, or become, familiar with the test procedures, standards and systems operated at the test facility. This familiarity with test systems and test procedures should be extensive enough to allow the individual inspector to choose the most suitable approach to the inspection of the study part he is monitoring, to ask the most pertinent questions, and to judge the importance of any deviations from study plan or from SQPs. Qn the other hand, it is certainly not necessary that Quality Assurance personnel should possess highly expert knowledge in the conduct of the tests and in the properties of the test systems they have to monitor, since the Quality Assurance inspector is expected neither to perform a scientific evaluation of a study nor to judge the validity of the scientific procedures that are used. 

After the qualification testing, a summary report should be written to summarize validation activities with a conclusion as to whether the instrument is suitable to be put into routine use. The report should highlight the objective and scope of the validation project, all the qualification test results, test exceptions, and a recommendation for system acceptance. All the test procedures, test results, and the summary report must be reviewed and approved by quality assurance and/or management before product use. 

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. 

GMP risk assessment Qualified/trained resource System life-cycle validation System environment Current specifications Software quality assurance Formal testing/acceptance Data entry authorization Data plausibility checks Communication diagnostics Access security Batch release authority Formal procedures/contracts Change control Electronic data hardcopy Secure data storage Contingency/recovery plans Maintenance plans/records... 

The OECD covers a series of activities and personnel. Responsibilities, training, quality assurance (QA), standard operating procedures (SOPs), study plans and study reports, data production and recording, equipment maintenance and calibration, computers and validation, test systems and test substances, and archiving are the primary areas covered by the GLPs. 

The USP standards do not mandate that certain tests be performed on given products. In fact, testing procedures and quality limits are determined and provided to the pharmacopoeia by manufacturers. Compendial requirements simply specify the tests that a pharmacopeial article must pass if it were subjected to the regimen specified in the USP. To that end, any validated procedure or sampling system can be adequate for the assurance of quality. Manufacturers can choose to strive for quality far above that dictated in the USP. The USP requirements should be viewed simply as the quality criteria that any manufacturer should be able to reasonably guarantee. 

The production of the API and finished dosage form is required to comply with GMP regulations discussed in Chapter 9 and Section 10.2. The quality system, quality control and validation of equipment and processes have to be developed and adhered to in the manufacturing process. Proper records and documentation are required to be kept in the forms of batch records, test records and manufacturing procedures. Reaction vessels and associated equipment must be calibrated, validated and cleaned to acceptable levels before being used this is especially the case for multi-product plants where more than one API is manufactured. 

Whilst a quality system does not provide a scientific justification for the type of tests conducted, it does encompass procedures to document the analytical methods used, to demonstrate that they are valid and under control, and to ensure that the laboratory personnel using the test method are adequately trained and skilled to perform the analyses. 

The equipment hardware and computer software should be developed and validated according to a documented procedure, e.g., according to a product life cycle. The vendor should have a documented and certified quality system, e.g., ISO 9001. Quality must be designed and programmed into software prior to, and during, its development phases by following written development standards, including the use of appropriate test plans and methods. 

In methods like TLC, validation must be performed in more levels. In the basic level, a scanner must be checked and calibrated according to the manufacturer s specifications. In the second level, it must be validated with a special test plate. This must be done at least once in a year, in order to obtain data about mechanical robustness, repeatability of measurements, monochromator accuracy, baseline noise, and the signal-to-noise ratio. This test plate is prepared by a vendor, and its purpose is detection of any possible malfunction. Too often, use of this informative but time-consuming and complicated test operation is questionable, especially because people in the laboratory are usually not able to repair a scanner, so a service-call is required. In order to know the actual quality of a scanner, a user must prepare a simpler procedure. This procedure can use a part of a vendor test plate, but it is better for each user to prepare an additional in-house test plate. The purpose of such a test is to check the quality of a scanner under working conditions on a daily basis. For accurate results, a third level may be introduced. The best way is to make a system-suitability test on each plate, selecting one spot on a plate, and measuring it with the working paramaters. 

The software life cycle activities extend until retirement of the software. However, in a manner of speaking, life cycle activities extend even beyond retirement since the data must be able to be reconstructed at any time during the life of the product, i.e., the archived record must always be accessible and readable even if the software is no longer commercially available or typically employed in the laboratory. Additional software validation includes implementation of the code and integration and performance testing. There also must be system security, change control procedures, audit trails, calibration, preventative maintenance, and quality assurance. 

Traditionally, the education that chemists and chemistry laboratory technicians receive in colleges and universities does not prepare them adequately for some important aspects of the real world of work in their chosen field. Today s industrial laboratory analyst is deeply involved with such job issues as quality control, quality assurance, ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. Yet, most of these terms are foreign to the college graduate and the new employee. 

Accreditation is the procedure by which the competence of a laboratory to perform a specified range of tests or measurements is assessed against a national or international standard. The accreditation covers the kinds of materials tested or measured, the procedures or methods used, the equipment and personnel used in those procedures, and all relevant systems that the laboratory has in place. Once accredited, the laboratory is entitled to endorse test results with their accreditation status which, if it has any validity, is an imprimatur of some degree of quality and gives the client added confidence in the results. Accreditation therefore benefits the laboratory, by allowing the laboratory to demonstrate competence in particular tests, and the client, by providing a choice of accredited laboratories that are deemed competent. 

As we develop alternative polyurethanes and composites, we must be aware that an efficient system of quality vahdation must be developed, concurrent with progress to meet design requirements. While many of the tests described above will constitute the core of the validation procedure, additional tests are needed to fully describe the functions of the materials. 

The system provides a new possibility for industrial manufacturing and galenical development of pharmaceutical solids specialties and has following purposes to make possible automated, unattended production, withdrawing from scale-up experiments, and thus a shorter development time for new specialties, with the aim of a shorter time to market. Manufacturing procedures can be simplified and validated faster, and the quality of granules, tablets, and kernels compared to conunon production is equal or better. Different solids specialties have been tested and validated. 

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