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NMR in Pharma: Application of Data Integrity Principles White Paper

Data Integrity (DI) principles are important to all those who generate, or use data because they underpin confidence in the data obtained and also in any conclusions drawn. Whatever the setting it is important, for example, to ensure that data has been obtained correctly by suitably qualified personnel using calibrated and maintained instruments and that the data has been stored in its raw form as well as with the metadata that unambiguously describes how it has been processed.

General descripton

Within the Pharma sector, the principles of DI have special status due to the fact that adherence is mandated by the industry regulators but primarily because the underlying reason is that non-adherence can lead to the loss of efficacy of pharmaceutical products and/or can cause its safety profile to be compromised: both these possibilities have serious negative consequences for patients. It is clear that DI principles are routinely applied to all scientific instruments that are employed within this sector. Despite some notable exceptions (especially the wellestablished use of NMR to determine the potency of reference materials1 as well as the widely employed process of structural elucidation / verification), NMR has tended not to be involved too directly in late stage pharmaceutical development and manufacture. The requirement to adhere to thegure 1 principles of DI have therefore been relatively infrequent. However, this position is set to change due in part to the significant recent interest in applications such as qNMR for the determination of potency of finished products.

 

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