MFT Pharma Solutions

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MFT Pharma Solutions

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We support organizations at every stage from start-ups to expansion projects.

MFT is a trusted consultancy partnering with pharmaceutical, biotech, and vaccine manufacturers to achieve compliance, operational excellence, and global growth.

09/10/2026

🧬 Help Shape the Future of Hands-On Biomanufacturing Training in Egypt
MFT Pharma Solutions is developing a practical, hands-on Biomanufacturing Training Program in Egypt, bringing expertise and know-how from the Netherlands to Egypt & Africa 🇳🇱🇪🇬🌍
And we want the people who will actually use it to help shape it.

If you are a student, fresh graduate, researcher, academic, laboratory professional, or working in the pharmaceutical/biotechnology industry, we would like to hear from you.
The program is being developed around key biomanufacturing areas including:
🧫 Mammalian Cell Culture & Aseptic Techniques
🦠 Microbial Fermentation
⚙️ Bioreactor Setup & Operation
🧪 Harvesting & Clarification
🔄 Tangential Flow Filtration (TFF)
🧬 Chromatography / ÄKTA / Protein Purification
📊 Process Analytics & Documentation

👉 Share your input here:

https://docs.google.com/forms/d/e/1FAIpQLSdoJ7rnmipEsHHHlpmIlysVyYqz6myRxW3XNHg_rwDUvH5j5w/viewform?usp=header
⏱️ It only takes a few minutes.

Through this short survey, we want to understand which skills matter most to you, how much hands-on practice you expect, your preferred training format and duration.
MFT Pharma Solutions
From the Netherlands to Egypt & Africa

29/09/2026

Cleaning and disinfection are not just housekeeping activities. They are part of your contamination control strategy.
Under EU GMP Annex 1, manufacturers are expected to demonstrate that their cleaning and disinfection programme is effective, controlled and scientifically justified.
Key expectations include:
• Clean first, then disinfect
• Use more than one disinfecting agent where appropriate
• Include periodic use of a sporicidal agent
• Validate disinfectant effectiveness under actual conditions of use
• Assess relevant surface materials and contact conditions
• Define and justify in-use expiry periods
• Use sterile disinfectants and detergents in Grade A and B areas
• Monitor the programme to confirm it remains effective over time
The key question is not:
“Do we have a disinfectant?”
It is:
“Can we demonstrate that our cleaning and disinfection programme actually works in our facility?”
MFT Pharma Solutions, we support pharmaceutical manufacturers in translating Annex 1 expectations into practical, risk-based contamination control systems.
For more information or support:
[email protected]
www.mft-consult.com

03/09/2026

Are you Annex 1 compliant?
Are you sure?

You may have updated your SOPs.
You may have written a Contamination Control Strategy.
You may have completed your cleanroom qualification.

But have you actually identified all the gaps?

And more importantly — have you demonstrated that they are effectively closed?

Annex 1 compliance is not achieved by updating one procedure or completing one gap-assessment spreadsheet.

It requires an integrated contamination-control system where facility design, processes, people, monitoring and quality systems work together.

Questions worth asking:

1- Does your CCS reflect what actually happens on the shop floor?
2- Have your contamination risks been assessed scientifically and linked to real controls?
3- Are personnel and material flows still appropriate for current operations?
4- Are interventions and aseptic manipulations properly assessed?
5- Is your environmental monitoring programme truly risk-based?
6- Have recurring EM excursions and microorganisms been adequately trended and understood?
7- Are cleaning, disinfection and sporicidal controls scientifically justified?
8- Are your APS/media fills representative of actual worst-case operations?
9- Are qualification, maintenance and calibration activities connected to contamination-control risk?
10- Are deviations and CAPAs actually eliminating recurrence — or just closing records?
11- Can you demonstrate ongoing verification of your state of control?

Because there is an important difference between:

“We completed our Annex 1 gap assessment.”

and

“We can demonstrate that our facility remains in a state of contamination control.”

At MFT Consult, we support pharmaceutical and biopharmaceutical organisations with:

Annex 1 gap assessments → CCS development/review → remediation planning → implementation → effectiveness verification → inspection readiness.

The question is no longer simply:

“Have you closed your Annex 1 gaps?”

The better question is:

“Can you prove the gaps are really closed?”

MFT Consult – GxP Excellence Partner | mft-consult.com

19/08/2026

MFT Pharma Solutions is proud to be part of the 5th Cleaning Validation and Environmental Monitoring Conference in Amsterdam.

Margrit Fares Mikhaeil, will present:

Contamination Control in the AI Era: From Environmental Monitoring Data to Predictive Risk Management

📍 Amsterdam, Netherlands
📅 11–12 November 2026
🎤 11 November | 15:50

We look forward to connecting with industry colleagues at 2026.

Sterile Pharma Manufacturing | Etapa Pharma

28/05/2026

📢 ISO 9000:2026 — Evolution, Not Revolution

The upcoming revision of ISO 9000:2026 is not about adding new requirements or expanding audit expectations. Instead, it is focused on something equally important: clarity, consistency, and better interpretation of quality management principles.

So, what is changing?

ISO 9000:2026 strengthens understanding—it does not complicate compliance.

For quality professionals and auditors, this revision is an opportunity to improve training, communication, and consistent interpretation without unnecessary procedural burden.

📌 The future of quality management is not more complexity—it is greater clarity.

How is your organization preparing for the upcoming ISO revisions?

24/05/2026

Digital Transformation Starts with the Right Fit
Digital transformation is not about implementing technology for the sake of technology. It is about choosing the right solution that truly fits your company, your quality system, and your operational processes.
At MFT Consult, we support organizations across the life sciences sector in transforming quality processes, strengthening data integrity, and selecting solutions that create real value—not unnecessary complexity.
Whether you are looking to improve:
✅ Quality Management Systems (QMS)
✅ Data Integrity & Compliance (ALCOA+)
✅ eQMS, LIMS, ERP, or MES implementation
✅ Process efficiency and audit readiness
We help you identify, design, and implement the solution that works for your organization—not a one-size-fits-all approach.

📩 If you are looking to transform your quality processes, reach out to explore the right digital solution for your company and processes.

17/02/2026

MFT Consult wishes our valued partners and colleagues a blessed Ramadan.
May this month bring strength, reflection, and meaningful progress.

14/02/2026

The 2022 revision of shifted the regulatory focus from contamination detection to contamination governance.

The expectation is no longer isolated monitoring activities. It is a structured, science-based, risk-driven Contamination Control Strategy (CCS).

QA leadership must now demonstrate:

• Integrated oversight across EM, cleaning validation, utilities, and facility controls
• Data-driven trend visibility and statistical justification
• Clear linkage between excursions, investigations, and CCS updates
• Lifecycle-based contamination risk management

Environmental monitoring is one verification layer, but governance requires system integration.

At MFT Pharma Solutions, we support manufacturers in structuring Annex 1-aligned contamination control frameworks and enabling digitalization strategies that integrate monitoring, trending, and risk management.

This includes implementation and validation support of integrated contamination control and environmental monitoring platforms, such as Novatek International ’s CC/EM software, to ensure audit-traceable data integrity and real-time governance visibility.

Digitalization is not an IT upgrade. It is a quality system maturity decision.

13/02/2026

Grateful to have attended WHX Dubai this week.
Beyond the scale of the exhibition, what stood out most were the discussions around regional manufacturing ambitions, localization strategies, and the increasing focus on regulatory maturity across the GCC.
As governments continue to prioritize healthcare security and local production, market entry into the GCC is no longer simply a commercial decision, It is a regulatory, technical, and strategic undertaking.
Successful market access requires:
~ Clear regulatory pathway mapping across GCC jurisdictions ~ Early alignment on GMP expectations and inspection readiness
~ Structured technology transfer frameworks ~ Strong CMC documentation and dossier positioning ~ Facility design that anticipates both local and international compliance standards

Pharma Solutions ,we see growing demand from manufacturers seeking structured entry strategies into GCC markets - whether through local partnerships, greenfield facilities, or technology transfer to regional sites.
The opportunity is significant.
But so is the complexity.
Sustainable market entry in the GCC requires more than distribution, it requires regulatory credibility, operational readiness, and long-term positioning.
Looking forward to continuing conversations with stakeholders committed to building compliant, future-ready manufacturing ecosystems across the region.

24/12/2025

As the year comes to a close, we extend our sincere thanks to our partners and collaborators.
Wishing you a Merry Christmas and a successful New Year ahead.
MFT Consult – Your GxP Excellence Partner.

Adres

Science Park
Leiden

Website

https://www.mft-consult.com/, http://mftpharmasolutions.com/

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