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Steve Biddulph, Managing Director, Galenisys

Table of Contents

By Tony Dunford
Editor

• A DRY JANUARY?
  By the Editor

• CORRECTING DEVIATIONS
  The first in a new series of articles on complex areas of QA, tools & techniques.
  By Steve Biddulph

• FDA WATCHING TAKES ON ANOTHER DIMENSION
  By the Editor

• THE PROJECT MANAGERS NOTEBOOK part 7
  Managing Change Requests plus Some Useful Tools: Clear Responsibilities, the 8 Soldiers, and PEST
  By "Aubonne"

In Brief:

• The doctor computer is busy. I'll ask him it to call you back
• Keeping well this winter

A DRY JANUARY?

By the Editor

After three weeks, the idea of having a complete month without alcohol was beginning to lose its attraction. So, one evening last week I decided on a gin and tonic.

After carefully measuring out the quantity of gin into the "priceless cut glass tumbler", I unscrewed the bottle of tonic water, & poured it in. To my surprise, there was no sign of the customary bubbles.

The truth slowly dawned - bottle only contained tap water. This I'd intended to use to top up the car's windscreen washers.

Of course, I had been misled by the tonic water label on the bottle, which I should have removed, as any GMP specialist would have done had they remembered the principle!

The incident set me reflecting on past incidents of "the wrong contents".

What's inside the container?

A few months ago, a Chinese State media outlet ran a scoop about liquid fuel road tankers also being used for carrying bulk cooking oil. There was an understandable amount of internet traffic following this, critical of the companies involved, one of which was government owned. The story was removed a short time later.

This was a real pity, because the more people know what should be done, the better things will get.

Clean & dry & labelled?

In pharma labs and labs and factories, containers should accurately reflect their contents; and if there are no contents, there should be no label except the one proclaiming the containers cleanliness status. To further reduce cross contamination risk product dedicated vessels, in e.g. the batch formulation areas, are a preferred solution, but "multi product" vessels need to have rigorous cleaning qualification to pass muster.

But do think upstream of formulation as well, since there are key precautions - Quality Technical Agreements - that should be covered by QA regarding your liquid & solid transporters - which Galenisys will help you with if you get in touch.

Now where's that bottle?

The Editor

CORRECTING DEVIATIONS

By Steve Biddulph

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

This month we're starting off on a series of articles which deal with tricky areas within a fully functioning GMP compliant Quality Assurance System.

Each month we'll detail an approach or explain a technique, which should be used by Companies in our industry; and which also illustrates a section of the Galenisys Quality Management System; which is available to help our clients.

Correcting Deviations

In our industry, whenever we encounter an "Out of Limit", "Out of Specification", "Out of Trend", "an unexpected/unusual event" or some kind of anomaly, we must investigate to try to determine the cause of the problem, how to correct it, and how to prevent it recurring.

Let's emphasize this - in the Life Sciences business a CAPA system (Corrective & Preventive Action) is necessary:

1. To understand the issue(s)
2. To correct them
3. And effect improvement(s) to prevent recurrence(s)

It is not simple to execute a structured system, to understand how to complete a comprehensive investigation, find the root cause(s) of the problem, define corrective and preventive actions and then test them for effectiveness.

Ignorance is not bliss

Companies require a robust system for reporting all kinds of problems. Personnel require training in the identification of problems, how to report them and to whom.

An initial assessment will always be required to ensure that the problem reported is a genuine one that should be investigated. Investigation will require a group of people who understand the environment and activities in which the problem occurred. They will need to determine what exactly went wrong – and the Root Cause – and if that is not obvious, then they must look at all possible causes. This is often the case when contamination is discovered in aseptic processing. A root cause of such contamination is often impossible to determine at the outset, so all possible causes need identification and investigation to define the necessary actions.

The investigation must cover a wide scope of similar activities, other products and batches that could have suffered from the same problem, other facilities and equipment, in fact any other area of the company's activities that could have possibly encountered a similar situation or been affected by the current problem.

When the cause or causes have been identified, corrective actions will be defined. These will be expected not only to correct the problem but also to prevent recurrence.

Implementation will be planned, and after successful implementation, the corrective actions must be reviewed to ensure that they really have cured the problem. These CAPA corrective actions must be implemented within the Change Control Procedure (see a future article).

Galenisys understands that a company can face difficulties addressing deviations through eg staff shortage or new product introductions etc. and may need assistance in designing / implementing a CAPA investigation.

Contact us to learn more how to access the section of Galenisys Quality Management System covering CAPA investigations; learn from our Case Histories or get on site assistance.

FDA WATCHING TAKES ON ANOTHER DIMENSION

By the Editor

At Galenisys we've always taken notice of FDA announcements, and their periodic emphasis on a particular aspect of cGMP. For example, in our December 2023 edition, Steve Biddulph focused our readers attention on the incoming FDA regulations regarding Cosmetics Manufacturing, and its implications.

So, the pronouncement by Donald Trump that his choice for proposed Secretary of Health was Robert F Kennedy Junior raised plenty of eyebrows, including ours. (Of course, the fact that RFK Jnr was previously a candidate in the presidential race, but in the end, backed Mr Trump is purely coincidental).

You see in the past, Mr. Kennedy has talked a lot about stopping vaccinations, (although he has toned down anti-vaccine criticism recently – prior to a Senate hearing confirmation). He's also learnt the populist technique so loved by his new boss, of saying outrageous and contradictory things which grab media attention.

For example Mr. Kennedy has talked about firing hundreds of staff, such as the entire nutrition department of the Food and Drug Administration, whereas reforming Americas Food System – a necessary & urgent matter – has been THE main health issue that he has advocated, and wants to achieve.

If you want to purge America's diet of processed foods which are full of additives such as artificial colours and other chemicals, how do you do that without having the FDA experts to analyse, and assess the recipes & evidence of the additive's safety? It doesn't take an Einstein to figure out that many of the additives are present in the ultra-processed food to make us eat more of it. There's general expert agreement that poor diet is responsible for a lot of the chronic diseases, particularly obesity, suffered by some 60% of the American population.

In the mix regarding the USA's health is the TV Doctor who has made weird pronouncements on live shows, picked by Trump as the man in charge of the centres for Medicare and Medicaid Services, & hence health coverage for 40% of Americans.

The things necessary to prevent chronic diseases are a healthy diet, less tobacco and alcohol, together with more sport at school, and better screening for the disease precursors. This is a clear "TO DO LIST" for Make America Healthy Again – MAHA of which we will no doubt hear much more in the future.

The chronic illnesses cost America dear in medical spending and lost productivity (an estimated $3.7 trillion in 2016). Much money goes on treatment (think of Prozac; Wegovy, Ozempic & Co) compared to prevention. So Mr. Kennedy is right to focus on this and wants the CDC (Centres for Disease Control and Prevention) to spend more of the Government funded research on prevention. But the CDC is headed by David Weldon (another contradictory Trump pick) since he is a vaccine sceptic, and the CDC oversees the country's vaccine roll outs! Hopefully the National Institutes of Health headed by another new man, will also research more on chronic disease prevention and nutrition. Yet another factor is that Mr Trump wants less regulation which will make lobbyists job easier.

How this will all play out is anyone's guess, but we'll keep on FDA watching.

The Editor

THE PROJECT MANAGERS NOTEBOOK part 7

Managing Change Requests plus Some Useful Tools: Clear Responsibilities, the 8 Soldiers, and PEST

By "Aubonne"

CHANGE OF PROJECT SCOPE ISSUES

One of the main risks to project completion on time and /or within budget arises from changes. These variations can be caused by incomplete design; or requests to include features, equipment, or capabilities which were not within original scope & intent.

Some scope changes can arise from external Political, Environmental, Social or Technological changes ("PEST" factors) which are out of the control of the project manager. This is part of the rationale for the inclusion of "contingencies" in the project budget.

Project Management needs to be particularly vigilant in avoiding "Scope Creep". For example, this can occur when a departmental manager, hearing of project approval, seeks additional requirements which had not been specified before. Either tell the guy to "find me the extra money & time"! Or, "cascade upward" the issue to the Steering Committee or Company Board accompanied by the clear Cost & Time implications of allowing the change. Prior to Project Approval (or Contract Signature) having appropriate functions sign off the scope, as implied in a Responsibility Matrix, (see below) or equivalent, helps avoid scope creep.

The result of such proposed or accepted changes is in all cases the delay needed to assess the implications. These implications themselves can be redesign costs, re-engineering costs, responsibility "unbuttoning", and altered contracts. Aspects of package compatibility, layout, pipework runs, qualification protocols, & safety may also be resulting headaches.

The RESPONSIBILITY MATRIX

The RESPONSIBILITY MATRIX can be a useful tool - particularly for large complex projects - for defining responsibilities & involving the necessary functions. Here's an example:

Do note that there are different types of responsibilities involved, and some are shown on the matrix:

• A: Approval
• P: Primary responsibility (for achievement)
• R: Review
• N: Notification
• O: (Receives) Output (and reacts)
• I: (Provides) Input
• B: Initiation

Depending on what the task is, both the functions and the responsibilities will vary in the matrix. Hence other key functions eg Production, Steering Committee, Company Directors, & outsiders eg Local Authorities, etc may be involved.

Examples of these more detailed matrices especially for the post sanction phases, are the Civil Engineering Package, Handling Scope Changes / Variations, and Payment Approval.

THE 8 SOLDIERS

Another useful tool is the old favourite. THE 8 SOLDIERS:
Who?, What?, When?, Where?, Why? On What Condition? How Much? How Often?

Intrinsic to the Responsibilities Matrix, are your 8 soldiers. Keep them in mind throughout the projects you manage.

"Aubonne"

The doctor computer is busy. I'll ask him it to call you back.

When a friend calls you to pull out of a meeting, he doesn't have to come to the end of his apology before you realise that he's not on form. One can tell from the voice that he is suffering from flu, tiredness, or just depression.

Yes, our voice indicates quite well our state of health. Enter computer with algorithm. A study published by the European Association for the Study of Diabetes showed that it could be pretty useful for detecting type 2 diabetes.

In trials with men and women, the machine correctly identified 71% of the men and 66% of the women who were afflicted by this disease. It's put down to modifications in breathing or nervousness on vocal cords, caused by diabetes. These are initial results, however.

But it points to a good area for continued research. In early 2024, a cardiology study suggested the possibility of detecting the early stages of heart disease by voice analysis. Here the algorithm correctly predicted 3/4 of the hospitalizations before they actually occurred.

Don't let Alexa talk to your insurers!

Keeping well this winter

Here's a handy summary to help avoid catching things, when family or friends get ill.

FLU victims are contagious up to seven days after the beginning of their symptoms. And COVID suffers are contagious for at least seven days after the start of their symptoms.

The Editor