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Compliance

Data Integrity and Compliance with cGLP and cGMP

For those working in regulated industries, the principles of Data Integrity (DI), cGLP and cGMP are especially important.   This applies to all who generate or use data because data integrity underpins confidence in the results obtained and in any conclusions that are drawn. Whatever the details of the analytical method, 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.

NMR

DI principles are routinely applied to all scientific instruments that are employed within this sector. However, despite some notable exceptions (especially the well-established use of NMR to determine the potency of reference materials, as well as the widely employed process of structural elucidation / verification), NMR would not appear to be heavily used for GxP purposes.  However, such a perception would be inaccurate as the technique is heavily used both during late stage development and manufacturing.  A GxP readiness kit was launched in early 2018 and was well received in the Market – a new kit was launched in October 2020.  The new GxP readiness kit incorporates the most up to date features that help customers be compliant with principle of data Integrity.

Vibrational Spectroscopy

Since analytical data are expected to be reliable and accurate, ensuring data integrity became a key component in current good manufacturing practice (cGMP). In this context, Bruker‘s spectroscopy software OPUS 8 marks the next generation of compliant software for IR, NIR and Raman measurements and data analysis.

Characteristic features include

  • Protected Data Pool: Permanent storage and protection against deletion, renaming, loss of the complete set of electronic records.
  • Comprehensive “Global Audit Trail” with filtering options, e.g. for a smart audit trail review
  • Next generation user and signature management and access control
  • Full compliance to FDA’s Data Integrity guideline and cGMP requirements e.g. 21 CFR Part 11

X-Ray Diffraction and Fluorescence

Bruker AXS’s instruments and software are developed by applying ISO9001 and 14001 certified product development procedures, based on US cGAMP and EudraLex Volume 4 Annex 15 requirements. The software supports 21 CFR Part 11 / EU Annex 11 compliance in regulated environments by offering several tools to provide and guarantee authenticity, integrity and confidentiality of electronic records and electronic signatures.

Bruker AXS also offers tools and expertise to help meeting the requirements of equipment qualification EQ (including design qualification DQ, installation qualification IQ, operation qualification OQ, and performance qualification PQ) for system validation.
 

More Information

New tools for Data Integrity (DI), compliance and good laboratory and manufacturing practices.

 

NMR under GxP in Drug Development and Manufacturing  

NMR in Pharma: Application of Data Integrity Principles