My reply to a post on LinkedIn.

Current TGA Inspection trends: This presentation will focus on the common types of deficiencies found by the TGA’s GMP Inspectors as well as some data on the number of inspections performed both locally and overseas and compliance rating outcomes for the inspections performed.

Comment 1 stated “…there are patterns that seem to repeat year after year. Poor QMS, inadequate investigations, lack of training.”

My reply to this was:

“The PIC’S guide to GMP stresses the need for a robust QMS and repeats over and over again the need for documentation, solid investigations and adequate training and retraining. It is a wonder why citations regarding a lack of these keep being given.”

Additional comments only here:

With regulatory audits continually finding the same deficiencies, there is clearly something wrong.  Either management only talks the talk and does not walk the walk, or those on the floor flaunt the documented procedures they are trained (and retrained) in.  Either way, QA’s not doing their job properly.  Perhaps management’s done a risk assessment based on risk to end-user, severity of citation and cost to comply.

I much prefer to operate in an audit ready state at all times.  Why?  Nobody runs around like a chook with it’s head chopped off when an external audit is announced.  If there are any deficiencies, they are known and plans are in place to fix them.  If such a deficiency is identified by an auditor, the plan to fix it is produced and that tends to make the them happy.

Documented plans are good.   If it is not documented, then you do not have a plan.