Advanced Therapy Medicinal Product (ATMP) Blog

How to Intelligently Optimise and Integrate Quality (QbD, QRM, QMS) into Advanced Therapy Medicinal Products (ATMPs)

I spoke on this subject at the Stem Cell & Regenerative Medicine Congress, Berlin, in September 2017, but let me summarise it in ONE minute (starting now).

IQ= QbD x QMS x QRM

Quality by Design (QbD)

A common question I get asked is “ATMPs are so complex that we can’t really use the QbD approach can we?”

My typical answer to this is: “the greater the complexity the more we MUST use QbD for necessary understanding!”

We have to delineate what really matters from what doesn’t to be able to make accurate science-to-patient-linked impact assessments.

Integrate understanding your product AND your patient; this requires excellence in both science and medicine, whether we’re considering CAR-T cells in oncology or cell and gene therapies for treating optic neuropathies such as glaucoma.

Quality Management Systems (QMS)

Great systems are to successful companies what great habits are to successful people.

They COMPOUND over time. So discipline yourself to continuously raise your standards and optimise your habits and systems before you automate.

Do this habitually and let the results compound in the right direction.

Quality Risk Management (QRM)

Get world-class at solving problems…then get even better at PREEMPTING and preventing them.

“A clever person solves a problem, a wise person avoids it.” Albert Einstein.

Integrated Quality (IQ)

Getting cutting edge at these simple basics (with practice, practice, practice) leads to inevitable excellence and quality.

My simple rule and acronym to help you remember these in your daily practice is to “always reference your work (REFS).”

That is, make it:

Risk-based

Evidence-based

Fact-based

Science-based/System-based

Get your FREE downloadable “20 Insights into BioPharmaceutiQals” at:

https://biopharmaceutiqalsacademy.mykajabi.com/20-insights

Dr Jasbir Rattu.

CeutiQus.

Innovating Quality Medicines Intelligently.

The Habit that Changed My Life Forever

“Who wrote this letter?” she asked in a stern tone, glaring down her spectacles at me.

My headmistress Miss Howard had called me to the front of the class.

I intrepidly walked to the front naively wondering if the cane was in force.

All this while my heart thumped my chest from within.

She was the strictest and most revered teacher in Heath Town CoE Primary School, Wolverhampton, UK (now called Trinity, CoE Primary School).

I had written and fraudulently signed a letter of sickness on behalf of my mother (because she couldn’t write in English).

I told Miss Howard I had written it, praying she wouldn’t realise I’d counterfeited my mother’s signature too.

I thought I’d been caught out but suddenly she asked, “where did you get this word ‘influenza‘?”

With a deep intake of air, I told her it came from my pocket dictionary (which my father had given me).

Then, with a glowing smile and soft but firm tone she praised me in a crescendo, “well done, well done…WELL DONE”.

In a remarkable twist, she seemed to be impressed and overjoyed. Was it because I knew the medical term for the flu? (At that time, I didn’t honestly fully know the difference between a cold and the flu).

Now gazing deep into my eyes, she paused then told me something that would stay with me for the rest of my life.

“Learn just one new word a day and you will go far.” -Miss Howard.

At the time I thought okay and what does go far even mean. Insidiously, it started to make me wonder…

That ‘one new word a day’ translated into new thoughts, ideas, concepts, mechanisms, perceptions, perspectives, voices, networks, breaking things down into their simplest units, consistency, good habits, continuous learning and much more.

In its simplest form, the habit she indoctrinated is that of continuous life-long learning.

Now over 30 years ago, and she is still the best teacher I ever had. I don’t know if she could have had any idea of the compounding effect of a few words of advice and encouragement.

She taught me many great things. However, in just this one sentence she had given an abundance of gifts: a great habit and the courage to follow through with what would have a ‘butterfly effect’ throughout my whole life.

I don’t know where she is or if I’ll even be able to see her again to show my gratitude, but I will always be grateful to her for the transformation that day and for being the best teacher I ever had. I think we all have a special teacher that has transformed us.

I have been teaching for many years now but this is one of the reasons I decided to teach.

I know if I could just do even for one person what Miss Howard did for me I could make an incredible impact on someone’s life.

“We make a living by what we get, but we make a life by what we give.”- Winston Churchill.

Great teachers do more than just teach; they inspire and change peoples’ lives, forever.

Biography:

Dr Jasbir Rattu is a Consultant Industrial Pharmacist EU Qualified Person (QP), Coach, Mentor and Trusted Advisor for multiple organisations (e.g. companies, universities, charities) in Pharmaceutical Biotechnology and Advanced Therapy Medicinal Products (ATMPs).

He is also the Director of CeutiQus and leader of The BioPharmaceutiQals Academy which teaches all critical aspects of Pharmaceutical Biotechnology and Advanced Therapy Medicinal Products (ATMPs).

The BioPharmaceutiQals Academy Masterclass (BAM) is a NEW Masterclass education series on the fundamentals of Pharmaceutical Biotechnology.

It teaches you the most important fundamentals that you need to start to accelerate your progress in your career or mission in just 9 days, with the right amount of time in between the teaching Masterclasses to allow you to apply and implement what you’ve learned into your workplace.

To learn more about the BioPharmaceutiQals Academy Masterclass (BAM) series course click here:

https://biopharmaceutiqalsacademy.mykajabi.com/BAM1

CeutiQus

Innovating Quality Medicines Intelligently