Behind Closed Doors: When Reality Emerges

Galenisys Newsletter : May 2026

Table of Contents

• TALES FROM FARAWAY PHARMA
  Catastrophic Issues!!
  by Steve Biddulph

• LUCY IN THE SKY WITH DONALD
  Too many crazies in “high” places already!
  By Tony Dunford

• NO HIDING PLACE
  Whether it’s an Internal Audit, or a PAI, Galenisys know where to look
  by Tony Dunford

• GOOD PERSONAL RELATIONSHIPS MAKE FOR SYNERGY
  Understand & respect roles to get results
  Tony Dunford

TALES FROM FARAWAY PHARMA

by Steve Biddulph

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

CATASTROPHIC ISSUES

Although I have encountered many amusing & interesting situations in our Industry during my journeys around the world; sadly I have seen, on occasion, some extremely serious episodes that question the ethics and morals in some parts of the Industry.

During a routine audit of a facility in the Far East, we found a critical issue, which concerned the high number of sterility failures that had occurred on large volume parenteral batches. Investigation quickly identified the purified water as the culprit. Autoclave loads were being cooled using purified water that had an “off the scale” bioburden due to it being used and reused time and time again.

Back at HQ, we stopped the manufacture of any further LVP batches and organized capital for the autoclave to be modified. Cooled fresh condensate was to be used in the future.

At HQ QA we received monthly reports from site on the modification progress, then completion, and a subsequent successful validation of the new cooling process. So, we gave the manufacturing site the green light to restart the LVP manufacturing unit.
Routine monthly reporting included the metrics confirming that there were no longer any issues with LVP sterility.

As the time for the 12 month regional follow up audit was coming around, the Industrial Operations VP for overseas manufacture asked to see me. He told me that in one of the far east countries there had been multiple serious illnesses reported (deaths) and that medical staff were identifying one of our products as being responsible. When the VP told me that the product was an LVP and that the site of origin was the site with the autoclave cooling issue, we quickly sent a team to the site.

The team found a catastrophic situation and conspiracy. The capital had been used to refurbish the administration building and offices, and no modification had taken place for the autoclave! In addition the CAPAs and monthly reports had been falsified.

The company took responsibility for the serious illnesses (deaths) of several affected patients and took appropriate action for the bereaved families. The manufacturing site director and other staff involved in the conspiracy were taken before justice, and of course fired.

The Lessons

The lessons were obviously:
• “Challenge what has been reported”
• “follow up rapidly and closely when life threatening situations are discovered”.

This issue has been with me ever since and my team and I thought over and over again what we could have done differently to have prevented this human catastrophe.

LUCY IN THE SKY WITH DONALD

By Tony Dunford

Too many crazies in “high” places already

In 1967 and the British rock group The Beatles penned the song “Lucy in the Sky with Diamonds” as part of the “Sergeant Pepper's Lonely Hearts Club Band” LP.
I was too young to know at the time, but the title was an illusion to LSD which members of the group probably tried out. Other pop stars of the ‘60s & 70s also created some songs referring to psychedelic drugs, and in following years the early deaths of stars such as Jimi Hendrix, Brian Jones, Janis Joplin, and Jim Morrison, - all drug dependent – were top of the news.

LSD (Lysergic acid diethylamide) is a semisynthetic hallucinogenic drug known for its powerful psychological effects and serotonergic activity. In the years following “flower power” etc, in the West, the political and social attitude towards these & other drugs changed as a result of the excesses, and things like LSD were frowned on.

So, the announcement by President Trump on 18th April in an Executive Order, that he wanted the FDA to give “priority vouchers” to psychedelic drugs such as LSD, so that the FDA would speed their approval surprised a lot of people and let “the worms out of the can again”.

Had Mr Trump listened to weighty advice from a panel of experts on the merits and demerits of each of the drugs? Unfortunately, not. He’d received a text message from an influential podcaster expounding the virtues of Ibogaine. (Ibogaine the drug touted by the podcaster is popular amongst veterans for whom opioid addiction is common, but it carries serious cardiac risks, including death). “You want FDA approval, let's do it” the President apparently replied.

His Executive Order boosted the shares of psychedelic drug makers and promised funding for new research into the field with an instruction for the FDA to issue these priority vouchers to speed NDA review. One company making a synthetic version of the active substance in “magic mushrooms” is closest to filing an application and another hopes to submit final data for a proprietary version of LSD this year. Even a generic drug that is a form of ketamine gets into the priority lane!

Indirectly the Order encourages “designer drug” chemists to come up with analogues of controlled substances (hallucinogenic or otherwise) that have been designed to mimic the pharmacological effects of an original drug, & avoid being classified as illegal, and/or avoid detection in standard drug tests.

Up to now the scientific basis for these of these sorts of drugs - for alcoholism, addiction, PTSD depression, and mood disorders - is weak. And there are many clinically approved treatments already.

The President's decision further reinforces the impression in scientific circles that the Administration is prioritising relationships and dollars over scientific merit key in deciding which treatments get priority. It follows the questionable judgement of the US Health Secretary on vaccines and encourages drugmakers (who already spend lavishly on lobbying), to increase “buttering up”.

In health matters Mr Trump should consider prevention rather than cure if there were fewer wars Mr President, there would be fewer PTSD veterans developing opioid addiction.

The Editor

NO HIDING PLACE

Whether it’s an Internal Audit, or a PAI, Galenisys know where to look.

By Tony Dunford

As Steve’s Faraway Pharma articles illustrates, site audits & inspection are an essential part of ensuring safe medication, regulatory compliance, & Corporate reputation. Many of the “Tales from Faraway Pharma”, relate the extensive experience that Galenisys has built up of various types of deviations found in all types of sites and locations by our “outside auditing”.
So, we’ve no hesitation in again stressing the importance of this aspect of Quality Assurance.

It was towards the end of the first day of the audit when the supervisor who was showing us around led me down a corridor near the dispensary.

There was closed door on the left-hand side, & I decided to have a look in. To my surprise I found a little treasure trove of kegs and sacks of raw materials, some ingredients for the various tablets and capsules that the facility specialised in.

The large provincial facility had been manufacturing pharmaceutical products for many decades, and it had an “institutionalised” feel.
The new QA Director wanted an independent view of the GMP compliance level of the area he was now responsible for and called in Galenisys to provide him with it.

Earlier in the day we had visited the automated warehouse in a separate building containing in appropriately segregated fashion, all the raw, intermediate, and finished products that were manufactured on site. It’s IT system registered the QC status of these and controlled which batches material were available for planning and production, or sale.

So, what was the purpose & status of the material in this room? I checked the kegs, reading the labels and noting down the details. When I asked the supervisor how these materials related to the stock registered in the IT system, he called in the senior operator, who advised me that the type and quantities of materials in the room were kept in a book on the desk in the corner.

Inspection then revealed some discrepancies of material type and quantity between what was noted in the book, and what was on the container labels.

There was no hiding place. the guy confirmed in effect that the room was being used as a convenient place to park the part used raw materials kegs or sacks, until next needed - rather than trekking with these “returns” to the Warehouse. This informal system was not only non-compliant but error prone in itself.

Steve recalls a similar incident in another facility we were auditing:
In the plant there was a storage area with restricted access. Since the door was open (!), we had a look inside. Stored there were cortico-steroids, some hormones and a few other materials. The booking out logbook in the room stated that the dispensary control sheets for these materials were not to be placed in a batch record. When batch records were audited, we could no mention of any of the materials.

The issue was brought before senior site management who said that R&D were always improving product formulations but did not think it necessary to re-register them!!

JAD / SB

GOOD PERSONAL RELATIONSHIPS MAKE FOR SYNERGY

Tony Dunford
Understand & respect roles to get results

Stan's first job must have been quite difficult. As a young serviceman just after the Second World War, it involved collecting body parts & identity tags or belongings, so fallen servicemen could be laid to rest in marked graves in the Commonwealth Cemetries in France.

I first started working closely with him when we were both based in the same manufacturing unit in which he was in charge of Quality Control, & I headed up the Purchasing Department. I involved Stan when we aimed to make some cost savings and quality improvements in sourcing bill of materials items. We got on well because we respected each other’s roles, with me learning more about QC operations & Stan experiencing supply issues.

He was open minded and liked to get out and about as a change from the routine supervision of his team's performance which largely involved sampling, testing and paperwork.

So, he was a useful chap to have with me when I toured various factories in Europe seeking new or additional sources capable of meeting specifications & becoming approved suppliers.

One example of this concerned Bormioli a glass bottle manufacturer who had a suitable capsule bottle but initial empty samples were found to have particulate contamination. We guessed it would be a problem when saw the packaging area. Stans’ guys identified this contamination as paper / cardboard fibres typical of packaging rooms.

He & I agreed how to tackle the obstacle. I negotiated a price for particle free bottle in a volume contract which would amortise the LFUs* which we specified (for purchase by the supplier) to be placed over the conveyor cooling bottles, before packing in clean plastic bags* inside the shipping outers.

Stan supervised the commissioning of these including teaching the supplier our particulate testing method, In short, a successful “Technology Transfer” project.

We were able to discontinue bottle blowing stations at various sites & Stans’ team had far fewer batch tests to do. These practices* are standard now but then in was largely a novelty.

One problem with aerosol mouthpieces is if the little hole through which a dose is delivered is malformed or blocked. Our QC department were occasionally knocking back batches where this was detected in some samples after delivery.

I'd located a promising local supplier whose boss was a qualified tool maker himself. Stan & I audited his facility & agreed that he had the technical knowledge and experience to execute this difficult injection moulding in a clean area. We explained in detail what we wanted - a very low level of the above defect in all batches ex-factory.

Again, a firm volume contract gave the supplier confidence to make an additional capital investment whereby there was 100% testing of mouthpieces automatically after they came out of the moulding machine.

In resume our approach was to modify QCs role from inspecting & rejecting batches to being a supplier improvement tool.

And Stan earned the ultimate accolade – that of being known as “a good bloke”.

The Editor