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Updated: Feb 26

Editorial | Open Access | Published 13th October 2023

GUEST EDITORIAL : Don’t Shoot the Messenger

Author : Malcolm Holmes

Don’t shoot the messenger is a common phrase for blaming the person who delivers bad news for actually causing the news.

Travelling the world as a global auditor / Pharmaceutical GMP consultant can sound quite an exciting life, and often it is, although at times when the outcome is bad news for the auditee / audited company, it can have a more worrying side. Here are few of my more worrying escapades.

In the mid-1980s a colleague and I audited a potential contract manufacturer / licensee in Poland. It was deep mid-winter in the time of the anti-authoritarian social movement (Solidarity). It didn’t feel too safe and indeed wasn’t. I managed to escape an attempted mugging as I boarded an early morning train from Warsaw to our destination some hours away. At the factory we sat with a very glum looking factory management team, who decided what we might be allowed to see during our audit. After a long debate the director finally agreed that I could use a pocket tape recorder as a means of recording my observations. We left the office area, and I dictated date and place onto the tape recorder when, suddenly, there was a tap on my shoulders and one of the escort team pointed at a heavily armed security person nearby and commented “The site director may have approved use of that recorder, but the guards do not report to the site director, and they are armed and suspicious”. The recorder stayed un-used for the rest of the audit.

On another occasion this time in Pakistan, I had completed an audit and the outcome for the company was certainly not favourable. I was given a ride back to my hotel with the factory director in his chauffer driven car. The director was someone I knew reasonably well from previous acquaintance – however I started to feel quite uncomfortable when we seemed to be driving away from, rather than towards my hotel (to avoid traffic congestion!!). Eventually, the car pulled up on some scrubland and we got out for the director to point out ‘something of interest’ to me. Then, out of earshot of the driver I was place under considerable verbal pressure to dilute my audit findings. Of course I didn’t do so, but nevertheless it was a pretty scary situation.

Once in the UK at an API manufacturer, I had found serious GMP issues in two separate manufacturing areas. One had suffered under investment seemingly for many years and the other had a critical operation which was no longer fit for purpose. Both would require significant capital investment to correct them. The Responsible Person for the site asked me what I was going to report to the site team and more importantly, to the company that had asked me to conduct the audit for them. Once I did so his worst thoughts were confirmed and he told me that I would probably be responsible for the closure of those operations, if not the site as a whole, with the subsequent loss of a large number of jobs. When I asked if he was aware of the issues and their seriousness prior to my audit, he confirmed that he was, but did not seem to see that his and the site management’s inaction over the years had caused the problem, not my audit.

Malcolm Holmes C Chem MRSC


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