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In May of this year I did a posting on the Quality Management Systems (QMS) that are obligatory for DS/PV departments based on FDA’s Quality Manual and the EMA’s Good PV Guidelines Module 1.

Since then I have done many audits of drug safety and PV groups around the US and Europe and, sad to say, most companies remain deficient in Quality Systems.

Here’s a quick review of what’s needed, what’s actually in place and some actionable things you can do.




Both FDA and EMA (and other agencies) have made it clear that they expect quality to be built into drug safety (and all pharmaceutical systems).  FDA expects a QMS with a mission statement, procedural documents/SOPs, clear management responsibilities, training, audits, CAPAs (when needed) and metrics.


The EMA is somewhat more specific in its module 1 requiring:

And finally the EMA notes that certain functions are critical and will be inspected by them:



The MHRA and other health agency inspections will indeed look at these areas.  See: https://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodPharmacovigilancePractice/Theinspectionprocess/index.htm#4  and https://www.mhra.gov.uk/home/groups/is-insp/documents/websiteresources/con175416.pdf

In these documents the MHRA notes the QMS areas that are often deficient.  There are many other areas of deficiency outside of the QMS area in the DS/PV departments.  See the first URL above:



The second URL covers MHRA inspection findings from April 2011 to March 2012 (the latest data available).  81 inspections were performed and the critical findings relating to QMS include: poor or lacking procedural documentation, training, CAPA management and MAH oversight.  Major QMS findings include problems in quality assurance auditing SOPs, the QMS, product quality and MAH oversight.  Minor/other findings include: quality assurance auditing SOPs, training, archiving, the QMS, and product quality.

From my audits I’ve seen: problems in audit/inspection readiness, siloing, lack of management oversight, poor or absent metrics, poor or absent training, little quality review in real time during case processing, lack of audits of the PV system, vendors, partners and CROs who handle safety, CAPAs that are never completed, and SOPs that are out of date, non-existent or divorced from reality.  To be more specific:



Some or all of these lacks will be cited by the inspector or auditor and some will be critical if they y cause case processing, patient protection, PSURs, expedited reporting and other critical functions to fail or falter.  Health authorities are doing “risk based” inspections now and will often make the assumption that if one big area is out of control, most or all of the other areas in the company are out of control.

The bottom line is that government inspectors are now doing serious PV inspections and will catch companies that are not doing adequate (or better) drug safety.  Many (though not all) government inspectors are highly skilled in PV and have seen it all.  They have inspected the great companies and the disasters and, in most cases, cannot be fooled.  It truly is in the company’s interest to take drug safety seriously and to be sure that a quality system is in place to ensure that drug safety and PV function well.

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