Importance of validating information

Representatives of the pharmaceutical and chemical industry have published papers on the validation of analytical methods.

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Green (11) gave a practical guide for analytical method validation, with a description of a set of minimum requirements for a method.

Renger and his colleagues (12) described the validation of a specific analytical procedure for the analysis of theophylline in a tablet using high-performance thin layer chromatography (HPTLC).

The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production.

The concept of validation was first developed for equipment and processes and derived from the engineering practices used in delivery of large pieces of equipment that would be manufactured, tested, delivered and accepted according to a contract Here, the software for a large radiotherapy device was poorly designed and tested.Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages.In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.Therefore, computer system validation (CSV) should be part of any good development and manufacturing practice.It is also requested by FDA regulations and guidelines through the overall requirement that "equipment must be suitable for it's intended use".The guidance states FDA’s expectations related to computer systems and to electronic records generated during clinical studies.

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