Hi PaulF

Hi PaulF

My head of Regulatory Affairs and Lead Internal Auditers would be fried by the FDA. I was a humble research assistant in those days and was happy to conform to very high standards and receive no ‘yellow perils’.

Production lines in Pharma have evolved to be devoid of human contamination hence accidental contamination can be considered a minimal risk.
I would by that same argument suggest that deliberate contamination (in this case apparently at least two other products) was even less likely. Yet it appears to have happened.

Hypothetical but each tablet/capsule has a low plus/minus tolerance in weight/volume and production line systems can be made (if not in place already) to detect any item that does not conform to tolerance levels and even appearance (identity markers/letters not visualised by micro imaging CCTV). This would normally halt the line automatically requiring a manual override after investigation.

How and at what point did contamination occur?

Are there not likely to be event triggered CCTV footage that would now get reviewed. (e.g. if someone vaults over a ticket turnstile at a rail station good CCTV systems automatically mark the event electronically as abnormal hence assisting review later)

What hasn’t been revealed in this case and may never is whether it was individual blisters that were contaminated in several strips, or an entire strip of blisters, …….

I think a lot should be learnt by Pharma by this scare as the technology is all available and they if any have the money to invest to safeguard their own backs.

Let me give you a parallel example from the microelectronics world. A large very reputable computer server manufacturer used home grown automated quality assurance systems in verifying if each mother board was acceptable. The test programs were home authored and it produced excellent results. Every board was checked at each stage of layering (additional components) and failures went automatically into a potential failed line and went through further checks to see where the failures were introduced. They then were able to identify batches of components or material that caused the failure and deal with supplier issues. Quality was very high on any board that left that manufacturing plant and still is.

Microelectronics by its name suggests items and components many of which are far smaller than most Pharma tablets/capsules and if microelectronics can get it right then Pharma can.

I totally agree it is a mindset, screening and standards of employee quality that also must be upped but the errors at manufacturing in Pharma can be reduced to almost zero.

I also agree with you that ticking boxes isn’t my idea of quality and it’s continuously upping the standards and reducing risk levels that gets things to 100% or near 100%.