Politics, Pathogens & Pharma Realities

Galenisys Newsletter : October 2025

Table of Contents

By Tony Dunford
Editor

• CLOSE SHAVES & COMPANY EXISTENCE
  By Bill Torpey

• Wrong again, Mr Secretary!
  Robert F Kennedy Junior creates another headache.
  By The Editor

• TALES FROM FARAWAY PHARMA
  My rumble in the jungle
  By Steve Biddulph

• THE RETURN OF THE VIRUS.
  Another warning
  By The Editor

CLOSE SHAVES & COMPANY EXISTENCE

By Bill Torpey

B.Sc in Applied Biology. 40 years’ experience in pharma & healthcare as production manager working across the dosage forms. Recently he spent 8 years working with Q A on validation.

In many of our newsletter articles we point out the scientific rationale of the precautions, tests and approaches we recommend to ensure Quality & Regulatory Compliance.

Our articles are drawn from the wide experience – the bad & good practice – which our team have experienced over the years.

In “Close Shaves & Company Existence”, Bill Torpey describes a classic example of real-world experience of encountering, managing, and rectifying non compliances (or not!).

The article has been anonymised to protect the innocent as well as avoiding blushes.

The Editor

In the mid 1990's I was recruited as Production Manager for a small factory here in Europe.

It was the country’s oldest ongoing pharmaceutical company, founded in 1846. They made and packed liquids - mainly cough syrups and aqueous solutions plus gels, creams and ointments.

Our own brands, and a couple of very good supply contracts for multinational companies and household names ensured a diversified range.The bulk batches were made in 4 x 6000 litre vessels plus quite a few smaller ones, provided high volumes and a very busy site. Sales and profits were in the millions.

The purified water was provided by a deionised water resin bed unit less than 2 years old. Shortly after starting there I noticed the flow rate in the system was very low. The system water samples were taken weekly and all were within the specified limits. The in line filters were within their annual replacement schedule and none were held in stock.

We decided to immediately order new filters and before fitting, stop manufacturing, empty the system, dismantle, inspect and clean the pipework.
Then refilling after several total flushouts, resampling water from the sample points. Then we arranged document checks to make sure all flow rates and filter pressure differentials in the correct range and all samples taken pass the specified limits for microbiology and chemical content. Only then would we restart manufacturing.

When we dismantled the system and thin film of black slime could be seen on the internal surfaces of some of the HDPE pipework.

This situation has had developed because:

• Staff had limited understanding of microbiology, with no technical support roles on site, nor graduates in manufacturing. Difficult in a small company.

• There were no routine daily monitoring, and recording of the results, or alert/action levels for all parts of the deioniser generation and distribution system.

• All information from the manufacturers Operating and Maintenance Manual was not incorporated into the site SOP's and PPM's.

• There had been no documented technical training of the largely very capable staff, in operating and maintaining the process.

• It was assumed that the annual filter scheme change would be adequate.

• No critical spares held in stock.

The overall result was a lack of understanding and appreciation in some areas of Manufacturing, QA and Engineering of the importance to the business of looking after a critical part of the production process.

I moved on a year later and shortly after that the factory was relocated to another site. After several years manufacturing on the new site a routine MHRA inspection found deficiencies in the control of microbiological contamination of the purified water supply. About 10 products were voluntary recalled, the manufacturing licence was suspended for three months and company’s share price dropped by some 50%. Some time later the site was closed.

I don’t know the exact circumstances but it would be sad if the new site had made the same mistakes we so narrowly avoided all those years before.
Of course, it's true that nobody knows everything. And people do not always appreciate the importance of what they don't know.

All these issues are comprehensively dealt with in the Galenisys Quality Assurance Program which is available to our clients.

Wrong again, Mr Secretary!

Robert F Kennedy Junior creates another headache.
By The Editor

As it seemed that Donald Trump needed a new subject to create the daily controversial headlines, the US Health Secretary persuaded his boss, to speak out on 22nd September against Tylenol the widely used paracetamol pain killer; on the unproven grounds that it caused autism.

Anti seed oils

At the time I was digesting the arguments, that have been put forward by RFK Junior, and a vocal lobby in the USA, against “seed oils”.

So, I’ll keep with this. “Seed oils “or vegetable oils as they are often called are from corn, rapeseed (“colza or canola”), soybean, sunflower, and others. The complaints are about Hexane used in their extraction.

However, the hexane is evaporated off later in the process. And any trace that may remain is “toxicologically insignificant” according to the US federal government publication in April.

A second objection is that seed oils contain Omega 6, which they say is pro inflammatory and “causes cancer, heart attacks and obesity”. The scientific evidence demonstrates the opposite.

Seed oils are very attractive for the consumer. They are cheap, have a long shelf life and a neutral taste and can be used as the base for much cooking. They contain Omega 6, but on balance they are neither pro or anti-inflammatory.

So, it's best to look at the overall effects of consuming these oils as opposed to alternatives. Our seed oils are high in healthy poly unsaturated fats. So, preferring them to butter, lard, & beef tallow, which contain saturated fats, lowers cholesterol levels, which cuts the risk of heart attacks.

This has been observed in long term observation studies. Nature Medicine recently looked at 100,000 American health professionals: those following diets high in vegetable oils lived longer, healthier lives than those who did not.
The WHO also weighed in with cohort studies published in 2022, finding that higher intake of Omega 6 fats was linked with a lower mortality.

Certainly, then seed oils are much better than the alternatives championed by lobbyists. (Not least butter, lard and beef tallow, that the industries producing large quantities of these from cattle and pigs, have a job getting a rid of any other way).

Kennedy's opposition to VACCINES is well known, and particularly dangerous. Vaccination rates are dropping in the US, bad for individual kids, and for herd immunity.

Let's hope RFK Junior has a (healthy) Departure ………. before the Arrival of DISEASE X.

TALES FROM FARAWAY PHARMA

My rumble in the jungle

By Steve Biddulph

Fellow of Royal Society of Biology. Board level pharma experience. QSM and Aseptic Manufacturing & Control Expertise. Galenisys Managing Director.

The Life Science Industries are truly global with Manufacturing Sites, CMOs and Licensees all over the world. This means that we technical people often have to travel to faraway places and meet challenges that are sometimes a little different from those found “at home”.

One of our licensees had a site in Northern Brazil that required assistance given the number of rejected batches which they were producing.
Enough was enough! It was decided that we would bring the site to an acceptable level of performance and compliance.

Arriving at the local airport we were struck by the number of people walking around with cotton reels attached to their legs. It was Local Hook Worm or the area equivalent of Guinea Worm infestations we were informed (don’t walk on the beach in bare feet!).
We had travelled in style and had shoes on fortunately.

Arriving at the site in the early morning we were greeted by a crowd. It consisted of hundreds of snakes lying on the solvent pipelines that served the fibre manufacturing plant. They were warming themselves in the sun to get body temperature up before a day out hunting……. nearby!

Inside the manufacturing site we began to evaluate the technologies used and the Quality System. Noting these in the factory’s various locations with a view to the various improvements needed, we couldn’t fail to notice the many signs of insect infestation.

The plant manager was asked to explain the site “Pest Control” programme. “This is not the jungle” he replied, trying to turn defense into attack.
However, all of us knew that the area outside resembled not a tree-lined boulevard or industrial zone, but a place to attract David Attenborough. “If it quacks & looks like a duck etc etc”.

Over the next days we found ants burrowing through the floor of the site (to devour the cough syrup), cockroaches by the thousands that only came out at night; and inevitably, rats.

Following our report and agreed plan, over the next 12 months the site manager and his team applied themselves to eradicating the pests and ensuring that the site was no longer a living zoo.

THE RETURN OF THE VIRUS.

Another warning
By The Editor

The virus returned in late August. They knew it would. It was just a matter of when.

In fact, it was the 16th time the deadly virus had started to kill people. By early September a score of people (including health workers) were confirmed victims, and the WHO had Officially confirmed the outbreak.

The key to preventing the thousands of deaths again, as occurred in earlier outbreaks, is fast response.What also matters is the fatality rate usually between 50 and 90%. And isolating sufferers before they (or dead bodies) can infect others by contact is vital.

Congo (DRC) is responding better now than before. Knowledge, logistics and medical capacity, have improved, and critically an effective vaccine is now available.

(A vaccine Mr. Kennedy, are you listening?)

It wasn't around when an outbreak in West Africa killed 11,000 people a decade ago and was still under development, in 2018-19, when many thousand more perished in the Congo.

Now some lucky people are now being vaccinated in Kasai. The knowledge, faster response, and the vaccine are positives.

However, Congo's health system has far too much on its plate including outbreaks of mpox and cholera elsewhere in the territory. In addition, the dollars from USAID have stopped. These helped fund investigations into the virus, mobile laboratories and planes to get experts and kit to the remote areas.

Meanwhile, the fruit bats, probable carriers of the disease, will continue to fly over the vast forested areas of the Congo, providing multiple opportunities for the virus to condemn locals via (immune) infected animals or “bush meat”.

(Ebola is in one of the virus families which could spawn Disease X).