Notes on the FDA’s Draft Data Integrity and Compliance With CGMP Guidance for Industry

Having worked in the pharmaceutical industry where I’ve dealt with electronic systems, paper based systems, programmed my own access databases and Excel spreadsheet  and been on projects such as LIMS system validation, I figured I’d make notes on the FDA’s 2016 guidance for industry document regarding Data Integrity and Compliance With CGMP.  This draft is for currently open for comment and the guidance addresses data integrity in:

  • drug manufacture
  • finished pharmaceuticals
  • positron emission tomography drugs

Continue reading

FDA Guide To Inspections

A great reference for ensuring you are audit ready are the FDA’s Guide to Inspections documents and Guidance for Industry documents.

The FDA Inspection guides are freely available from here.

For my own reference and review, I’ve saved some of the Guidance for Industry documents below.  However, you can get them all from this link.