From Shrimp Tales to Smart Pills: Pharma Realities
Galenisys Newsletter : November 2025
Table of Contents
By Tony Dunford
Editor
-
TALES FROM FARAWAY PHARMA
COLUMBIA: THE SEEN & UNSEEN RISKS
By Steve Biddulph -
SHRIMPS, ALIENS, AND HEALTH SECRETARIES
By The Editor -
CHECK THAT FAT!
Small problems can cause big delays
By Bill Torpey -
TYLENOL AND SMARTIES
The President’s drug pricing actions will affect everybody
By The Editor
TALES FROM FARAWAY PHARMA
COLUMBIA: THE SEEN & UNSEEN RISKS
By Steve Biddulph
Fellow of Royal Society of Biology. Board level pharma experience. QSM and Aseptic Manufacturing & Control Expertise. Galenisys Managing Director.
Colombia was a very challenging place in which to manufacture pharmaceuticals. The company I was auditing was a CMO with three different sites in Bogota, and they all made our products under contract.
Since I spent around three weeks auditing these sites I got to know the owner’s son very well. He asked if I was staying for the following weekend and I said that I was. Be very careful, he advised, stay in the hotel if possible.
“What do you do at weekend? I asked. He told me he flew to Miami every Friday afternoon to be with his family there and then flew back to Bogotá on Monday morning.
This was to prevent his children being kidnapped and held to ransom, he explained.
All three sites manufactured sterile products and beta lactamines. The aseptic filling suite never had any contaminants picked up by the environmental monitoring programme.
However, there were many people moving around in the filling zone and class A (ISO 5) conditions were “achieved” by a simple unidirectional airflow cabinet, but personnel were interfering with the filling line on many occasions.
SEE NO EVIL
Of course, there was no penicillinase used in the agar plates, and no growth promotion testing on the exposed plates after incubation, which would account for “zero” contamination.
Please don’t think that this was / is limited to Colombia - the same issue was found at a CMO in the UK several years later.
Strange isn’t it – people see some risks but not others!
For “Another pair of eyes …” GET THE BEST GET GALENISYS
Steve Biddulph
The following documents in GALENISYS STANDARDS guide our in-depth auditing of CMOs in our clients supply chains:
- AUDITING CHECKLISTS > AUDIT AIDE MEMOIRE – SUPPLY CHAIN
- COMPLIANCE ASSESSMENT DOCUMENT V9
The Editor
SHRIMPS, ALIENS, AND HEALTH SECRETARIES
By The Editor
If I hadn’t seen & heard him on his press release website, I would have thought it was fake news. But there he was, the US Secretary of Health, John Kennedy Junior addressing the US Senate, and advising them that raw frozen shrimp from Indonesia being sold in America were, quote:
“... radioactive... and eating them will turn you into an alien (sic)”
The amazing comments continued “... If you eat it (shrimp) you could end up looking like an alien...it will kill you...even if it doesn’t turn you into an alien, I guarantee that you will grow an extra ear...”
To be fair the Secretary has a hard time getting headlines when his boss likes to monopolise the evening news with equally wild comments.
But it’s possible our dear Secretary simply misunderstood - he’s likely confused between radioactive & irradiated. Such distinctions may be beyond him.
Fish & other seafood are irradiated and to quote the FDA in their March 2024 publication:
“Irradiation does not make foods radioactive, compromise nutritional the taste, texture, or appearance of food. In fact, any changes made by irradiation are so minimal that it is not easy to tell if a food has been irradiated.
Food irradiation (the application of ionizing radiation to food) is a technology that improves the safety and extends the shelf life of foods by reducing or eliminating microorganisms and insects. Like pasteurizing milk and canning fruits and vegetables, irradiation can make food safer for the consumer. The Food and Drug Administration (FDA) is responsible for regulating the sources of radiation that are used to irradiate food.
The FDA approves a source of radiation for use on foods only after it has determined that irradiating the food is safe..."
“The FDA has approved a variety of foods for irradiation in the United States including:
- Crustaceans (e.g., lobster, shrimp, and crab)….”
Mr Kennedy continued his address by criticising the FDA (!) and the National Oceanic Atmospheric Administration.
Of course, he ignored the fact he is the boss of the FDA (“FOOD & Drug Administration”) which he recently purged of vaccine specialists, whilst staff elsewhere are furloughed because of the current impasse on the US budget.
His wildly garbled narrative continued “…. there's no excuse for it I didn't know they were shooting them full of this radioactive isotope that's if you eat enough of the foreign shrimp, you'll become resistant to certain bacteria in America because the antibiotics don't work on it anymore because you’ve eaten so many shrimps that contain the antibiotics ….”
Now we come to the political bit and understand just a little better: “I believe in the homegrown Louisiana shrimp fresh out of the Gulf* not radioactive shrimp ….” and it just so happens that our Mr Kennedy is the US senator for Louisiana.
(The same “Gulf of Mexico” into which the Missippi river pours all sorts of effluent every day).
Since the US Secretary of Health has the serious problem of saying things which are not true, a lot of fact checking needs to be done before dismissing him a lunatic. Because it may be one day he has to tell something both vital and true about a Public Heath Danger to the American public (like the bird flu strain crossing the species barrier to humans).
A further serious point: the Pharma & Food Industries are guided by the Regulatory Agencies (of which the FDA is arguably the leading one), which for decades have - rightly - insisted on true & verifiable data & statements from our Industry.
What example does Mr Kennedy set, & what is the impact on his Agency’s standing?
The Editor
CHECK THAT FAT!
Small problems can cause big delays
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
Many years ago, I was hired on contract to provide validation support for the transfer from one site in Europe to another of the hard capsule blister packaging with a new machine. There had been delays with the project, so product stock levels were low. A FAT had been carried out on the machine suppliers’ site without a client representative, a few weeks before I arrived & shortly before the planned SAT date.
Both customer and supplier were large multinational companies who had done business together for many years successfully on similar projects.
During the initial few days of the SAT the feeding systems, sensors, vision systems, reject mechanisms, leak tests etc all passed.
Unfortunately, the SAT itself failed, because the batch number and expiry date on the blister strips were illegible because they were embossing onto the print which covered all the foil, instead of the plain laminate side!
Clearly the FAT had either not been done as intended with filled blisters returned to QA for approval. The work round had to be a replacement reel of aluminium lidding foil print on the reverse; as the embossing block could not be flipped as with some machines.
As the clients Purchase Order scope did not cover this, the client took the cost hit of a repeat SAT & material usage & impact on finished stock.
The experience I’m sharing with you highlights probable causes of the failure:
- The past good commercial relationship, and machines performance resulted in client complacency, and so no representative was present or samples provided.
- Suppliers usually try to “….reserve the right introduce improvements & modifications our machines..”. Translated this means “our new ones are not necessarily the same as the old ones”.
- It was wrongly assumed that the approved aluminium lidding foil print artwork left room legible embossing.
- It was also wrongly assumed print block station could be set to emboss either above (on the foil) or below (on the laminate) before the cutting station, as was the case on other blister packing machines.
Let’s reiterate some key points for all FATs:
- The main purpose of a machinery Factory Acceptance Test (FAT) is to confirm that the machinery conforms to the clients Scope, Specifications (URS) & QA requirements which are referenced in the clients Purchase Order (the legal contract).
- The buyer wants the FAT test runs to mimic the future production runs on their site as much as possible and should supply the materials and components in adequate quantities and to the correct specifications, (although It’s not always possible to exactly replicate site conditions eg think batch size constraints, run length, & HAZOPs.
- Suppliers may prefer & quote for their own (often slim) generic FAT however such divergent “wants” need to be settled pre contact by the clients team.
- With the above context clear the client’s representative can attend the FAT & carry their useful experience to the subsequent SAT.
Otherwise, small problems can cause big delays.
Bill Torpey
TYLENOL AND SMARTIES
The President’s drug pricing actions will affect everybody
By The Editor
Being without free or subsidised national health schemes, (excepting tiny Medicaid), Americans hate their high drug prices (or other expensive health costs). Both political parties agree on doing something about it. They point to the fact that America's list prices for branded drugs are on average, more than four times those in other rich countries.
So, Donald Trump ever the populist, told drugmakers to cut their prices to most favoured nation levels, (“MFN pricing”) ie to the cheapest price out there in the developed world, instead of “abusive” prices, …… or else.
Now the pharmaceutical industry has one of the most integrated global supply chains of all manufacturing sectors. What is threatened will disrupt this. The President’s actions, eg 100% tariffs on imported branded drugs from 1st October, (with softer penalties for manufacturers on shoring to USA), will clearly push costs up not down. His hoped for new fill & finish factories will be expensive and take several years to build & receive accreditation. Nor is it easy to see USA plants producing APIs more cheaply than the current hubs in India etc
But his current hot topic may just fail or even make healthcare in America worse.
Anyone familiar with the USAs present health system knows that inefficiencies and price gouging abound. However, as The Economist pointed out in a study, 60% of the “excess” profit (ie return on capital above 10%) is taken by US hospitals, insurers, distributors and pharmacy benefit managers (“PBMs”). Cutting these layers & fairer competition would lower prices. But even then, it’s estimated drugs in America would remain 3 times dearer than in the rest of the rich world.
Why then do American patients pay more? Firstly, many European Governments buy the drugs for the nation’s public health systems and thus have a stronger negotiating hand.
Secondly, they buy on the basis of perceived value to patients eg the UK’s Quality Adjusted Life Years (“QUALYS”). Being pickier means some 20% of new drugs, which are available in USA are not in Europe. Those which are, are approved 6months later in EU, & 3 years later in Japan.
“Do you want it now or in 3 years”
If Trump forces prices lower, it’s likely that some future new innovations (hence expensive) drugs would not reach sick Americans. In resume less money means less cutting edge medication.
Pharma manufacturers spend R&D money over decades but roughly 90% of clinical drug development fails. Lower prices inevitably mean less such risk taking.
And in the end, it’s successful R&D which leads to all the future low-cost generics. I recall my old friend – a QP at a generic tablet maker - ruefully remarking that his company’s paracetamol (it’s like Tylenol Mr Kennedy), sold at less than tubes of Smarties in supermarkets.
The Editor
