The MHRA’s GXP data integrity guide has been published today.
Senior GMDP Inspector and GMDP Operations Manager
Medicines and Healthcare products Regulatory Agency (MHRA)
Tracy has been with the MHRA GMP Inspectorate since 2011 and prior to joining the MHRA worked in the pharmaceutical industry for over 22 years. She worked across all dosage forms within Quality roles. She is eligible to act as a Qualified Person under 2001/83 and did so for 6 and a half years within a sterile manufacturing capacity before joining the agency. Tracy is the lead for the Agency team responsible for delivering data integrity strategy and training.
Potential patient safety issues, serious breaches of GMP or suspected criminal activity frequently trigger short notice or unannounced inspections
An update on the use of short notice and unannounced GMP inspections