MTL - BROCHURE 2018 SINGLE PAGES

What we do

❝Mark is a very personable guy. He has a
fantastic drive for results, is very customer
focused, creative and leverages from a deep
understanding of the pharma industry.
He inspires these qualities in his team also
which results in a great end product.❞
Gary Hartnett, Bausch & Lomb

❝Mark has an in depth working knowledge of regulatory
standards and applies his vast experience to offer robust
technical solutions, training and guidance.❞
David McGovern, Business Transformation Projects Manager, GE Healthcare
About MTL
MTL are a team of
specialists with decades of
pharmaceutical industry
experience.
2018/19 sees MTL involved in:-
Project Support to major
facility expansions and new
equipment.
Regulatory and
Troubleshooting guidance.
Audit services; pre
inspection, self inspection
and third party.
Bespoke / Tailored Training
Packages
All of this delivered across the
spectrum of Sterile product
manufacture and all over the
world.
As our team has expanded so
has our range of Consultancy
and Training Services:-
Sterilisation and
Depyrogenation
High Purity Water Systems
and Critical Utilities
Clean Room Technology,
RABS and Isolators
Automated and Manual
Visual Inspection
Pharmaceutical Engineering,
Projects, Maintenance
Qualification,
Requalification Annex 15
Implementation
QRM and Process Risk
Assessments
Intelligent application
of this knowledge and
experience is where we
win. Our consultants
extensive experience and
ongoing work within the
pharmaceutical industry
ensures that the work
delivered is benchmarked
with current Regulatory
Expectations and feedback
as well as Industry best
practice.

❝Mark provides an excellent portfolio of training and
consultancy around GMP, pharmaceutical engineering,
sterilisation, compliance and water systems.❞
MTL - Training
Nick Batty, Quality and Compliance Training Manager
at Health Protection Agancy
NEW FOR 2018/19;
ACCREDITED TRAINING
Working with GXP Training we are getting our main
Hotel training courses accredited by the School of
Pharmacy at University College Cork.
gxp
training
Our Open Courses (Part of the GXP SME series
of Training Courses) are going through the
accreditation process which has already completed
for Sterilisation and Depyrogenation, accreditation
means that each of these courses delivers 5
University Credits. The courses include regulatory
perspectives from ex inspectors as well as on going
consultancy support from the trainers to assist in
the development of your site SME’s.
This suit of SME Courses gaining accreditation
currently includes:-
Sterilisation and Depyrogenation
High Purity Water Systems
Pharmaceutical Engineering
NEW FOR 2019; VIDEO MODULES
Several of our Training packages
are being made available as Video
modules to enable refresher
training or wider team based
training on specific subjects.
Throughout 2018 several clients
have asked for Video modules of
training delivered on site to allow
wider training across site, new
starters training etc.
Our website includes video
module download options on key
subjects and the list of subjects
is ever increasing so subscribe
to the email system for regular
updates on this.

Our Tailored on
site course delivery
continues to be as
popular as ever
What is unique about MTL Training?
• Courses are tailored to site specific
technology, regulatory requirements and
needs
• Training and development plans are created
as an output from the training contribute to
individual and team based development
• Full colour, high quality indexed training
material is provided and is a valuable
reference resource for the future
• Courses can be delivered on site so they suit
shift patterns and availability
Our Training
Courses
Sterile Product Manufacture
Sterilisation and Depyrogenation
High Purity Water (WFI and PW)
Critical Utilities
Lyophilisation
Introduction to Pharmaceutical
Engineering
Pharma Eng and GEP Trends
Clean Rooms, HVAC and Filtration
Process Risk Assessment for SAL
Risk Assessment for Deviation Handling
Bioburden Control and SAL
Steam Quality Testing; Theory and
Practice
Project Engineering Systems
Commissioning and Qualification;
Annex 15
Automated and Manual Visual
Inspection (add after Lyophilisation)
RABS, Isolators and VHP (add after Clean
rooms, HVAC and Filtration)

| CASE REPORT - TRAINING
ON SITE STERILISATION TRAINING
PROGRAMME
North West Ireland
Client needs
The client had an extensive requalification
programme for porous load and fluid load
sterilisation processes on site. This programme
required 54 man days per year of requalification effort
as well as production downtime, yet sterilisation
deviations were still an adverse trend on the site.
The client needed to improve confidence and reduce
deviations in the sterilisation processes on site. To
deliver this, a comprehensive up skilling and training
and competency assessment for everyone involved
in the sterilisation process from Operations to QA
Review was required.
What we delivered
Based upon site survey, discussions and analysis
of the current approach we developed a series of
training courses for the site.
Each course developed was site and process specific
so the actual loads, cycle design, autoclaves and site
procedures were used in the training. This included:
• 2 day Operations and QA Course
• 3 day Engineering, Technical and Validation Course
• 1 day additional Thermal and BI Validation
Practices Course for the Validation and QA teams
• Ongoing training support to develop 2 site SME
resources on Sterilisation
Each course was delivered with comprehensive,
indexed course notes based upon actual site
autoclaves and processes.
A common feature of our training courses is that high
quality colour and well indexed course manuals are
delivered that serve as a reference tool in the future.
Detailed competency assessments, ranging from
operations multi choice questionnaire to written
papers for the technical, validation and SME
resource were developed. These demonstrated
learning outcomes and the application knowledge.
Certificates based upon this competency assessment
were awarded.
The results
• Deviations linked to sterilisation processes fell
dramatically
• Operation’s involvement and understanding
of the process identified many improvements
linked to quality assurance as well as efficiency
improvements.
• The training in thermal and biological validation
identified several opportunities for applying latest
best practice and advancement in technology
to simplify the qualification and requalification
processes.
The ROI
Sterilisation related deviations were
significantly reduced which was the
primary objective of the work.
Requalification workload reduced from
54 man days to less than 30 man days
through rationalisation and application
of current best practice for qualification
of sterilisation processes.

❝Whenever a company had a problem, Mark was the person
to provide the solution, rather than just a temporary patch.❞
MTL - Projects
Stan O’Neill, Managing Director, The Compliance Group
ASTM E2500 and many other recent standards and
guidance documents require the proper application of
Good Engineering Practice (GEP) and Subject Matter
Expertise (SME) throughout Projects. Mark Thompson
Lifesciences deliver this in a number of areas.
Recent updates to Annex 15 of the EU GMP guide
Projects undertaken
also require a much more detailed and considered
approach to process risk assessments, design
qualification (DQ) and requirements traceability
matrices (RTM) on projects. When applied properly,
this approach delivers huge benefits to the quality and
understanding of the delivered process.
PROJECT LOCATION DELIVERABLES
New Parenteral product
Formulation and Aseptic Fill
Finish facility
Facility Expansion Project for
Terminal Sterilisation Facility
Sterilisation Process
Improvement on Aseptic Fill
Finish Facility
New Filling Line in Parenteral
Product Facility for both Aseptic
and Terminally Sterilised
Products
New High Purity Water System;
Generation Storage and
Distribution for a 45m3/Hr High
Purity Water System
High Purity Water System
Upgrade. 18MOhm water
system generation storage and
distribution
Ireland
Ireland
UK
UK
China
UK
Consultancy Support and Project Guidance throughout including the
Contamination Control Process Risk Assessment, URS development,
Design Qualification and Requirements Traceability Matrix
Consultancy Support to Sterility Assurance Risk Assessment and
Qualification approach to Sterilisation in Place Processes
Audit and Process Review to ensure regulatory compliance and
identify action plans for process improvement. Training and
development of site expertise and Subject Matter Expertise in:-
• Sterilisation and Depyrogenation
• Pharmaceutical Engineering
• Steam Quality Testing
Contamination Control and Cross Contamination Control Process
Risk Assessment. Development of Validation Master Plan, Validation
approach and scoping the qualification activities based upon Process
Risk Assessment and Design Qualifications
URS Development, Supplier Auditing, Design Qualification and
Project support throughout Validation. This project run in conjunction
with Crystal Clear Engineering, delivered and led by MTL
Consultancy support to scope the most appropriate project solution,
URS Development and ongoing consultancy support. This project run
in conjunction with Crystal Clear Engineering, delivered and led by
MTL
Critical Utilities System Review Netherlands Aged Plant analysis and Critical Utilities Review in response to FDA
observation
Steriliser Upgrade Project to
meet current GMP and EU
standards for Sterilisation
Processes.
Pre US FDA Inspection of
Aseptic Fill Finish Facility
Biological Indicator Receipt
verification. D value testing
Bio burden Control and Micro
biology control improvements
Belgium
India
3 sites in
Ireland and 1
in UK
Brazil
Consultancy Support and Training for Upgrade Project. On site cycle
development and air detector set up work
Pre Audit inspection and consultancy support in preparation for first
site FDA inspection
Receipt verification of Biological Indicators is defined in USP and
EP. Performing independent D value determination is problematic
so many sites are changing to running a sub lethal cycle which is in
full compliance with EP and USP requirements. Project and Change
control assistance being supplied to drive through the change.
Project Delivered for the Gates Foundation at a vaccine manufacturer
in Brazil

❝Mark has led the provision of
sterilisation related external advice
and contracted service to our
company in Cork, Ireland for over
10 years. He and his team have
always been well informed on the
requirements but also pragmatic
in how these could be delivered
in a cost effective manner. They
have always been flexible to tie in
with company time limitations and
have been reliable in the quality
and timeliness of documentation
produced. Mark has also been
an invaluable source of ad hoc
information to help support
regulatory or inspection queries
and to assist in the resolution of
technical problems.❞
Danny Healy, VP QA, Trygg Pharma
CONTACT US:
+44 (0) 7780 430383
enquiries@markthompsonls.com
markthompsonls.com