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What we do

❝Mark is a very personable guy. He has a<br />

fantastic drive for results, is very customer<br />

focused, creative and leverages from a deep<br />

understanding of the pharma industry.<br />

He inspires these qualities in his team also<br />

which results in a great end product.❞<br />

Gary Hartnett, Bausch & Lomb

❝Mark has an in depth working knowledge of regulatory<br />

standards and applies his vast experience to offer robust<br />

technical solutions, training and guidance.❞<br />

David McGovern, Business Transformation Projects Manager, GE Healthcare<br />

About <strong>MTL</strong><br />

<strong>MTL</strong> are a team of<br />

specialists with decades of<br />

pharmaceutical industry<br />

experience.<br />

<strong>2018</strong>/19 sees <strong>MTL</strong> involved in:-<br />

Project Support to major<br />

facility expansions and new<br />

equipment.<br />

Regulatory and<br />

Troubleshooting guidance.<br />

Audit services; pre<br />

inspection, self inspection<br />

and third party.<br />

Bespoke / Tailored Training<br />

Packages<br />

All of this delivered across the<br />

spectrum of Sterile product<br />

manufacture and all over the<br />

world.<br />

As our team has expanded so<br />

has our range of Consultancy<br />

and Training Services:-<br />

Sterilisation and<br />

Depyrogenation<br />

High Purity Water Systems<br />

and Critical Utilities<br />

Clean Room Technology,<br />

RABS and Isolators<br />

Automated and Manual<br />

Visual Inspection<br />

Pharmaceutical Engineering,<br />

Projects, Maintenance<br />

Qualification,<br />

Requalification Annex 15<br />

Implementation<br />

QRM and Process Risk<br />

Assessments<br />

Intelligent application<br />

of this knowledge and<br />

experience is where we<br />

win. Our consultants<br />

extensive experience and<br />

ongoing work within the<br />

pharmaceutical industry<br />

ensures that the work<br />

delivered is benchmarked<br />

with current Regulatory<br />

Expectations and feedback<br />

as well as Industry best<br />


❝Mark provides an excellent portfolio of training and<br />

consultancy around GMP, pharmaceutical engineering,<br />

sterilisation, compliance and water systems.❞<br />

<strong>MTL</strong> - Training<br />

Nick Batty, Quality and Compliance Training Manager<br />

at Health Protection Agancy<br />

NEW FOR <strong>2018</strong>/19;<br />


Working with GXP Training we are getting our main<br />

Hotel training courses accredited by the School of<br />

Pharmacy at University College Cork.<br />

gxp<br />

training<br />

Our Open Courses (Part of the GXP SME series<br />

of Training Courses) are going through the<br />

accreditation process which has already completed<br />

for Sterilisation and Depyrogenation, accreditation<br />

means that each of these courses delivers 5<br />

University Credits. The courses include regulatory<br />

perspectives from ex inspectors as well as on going<br />

consultancy support from the trainers to assist in<br />

the development of your site SME’s.<br />

This suit of SME Courses gaining accreditation<br />

currently includes:-<br />

Sterilisation and Depyrogenation<br />

High Purity Water Systems<br />

Pharmaceutical Engineering<br />


Several of our Training packages<br />

are being made available as Video<br />

modules to enable refresher<br />

training or wider team based<br />

training on specific subjects.<br />

Throughout <strong>2018</strong> several clients<br />

have asked for Video modules of<br />

training delivered on site to allow<br />

wider training across site, new<br />

starters training etc.<br />

Our website includes video<br />

module download options on key<br />

subjects and the list of subjects<br />

is ever increasing so subscribe<br />

to the email system for regular<br />

updates on this.

Our Tailored on<br />

site course delivery<br />

continues to be as<br />

popular as ever<br />

What is unique about <strong>MTL</strong> Training?<br />

• Courses are tailored to site specific<br />

technology, regulatory requirements and<br />

needs<br />

• Training and development plans are created<br />

as an output from the training contribute to<br />

individual and team based development<br />

• Full colour, high quality indexed training<br />

material is provided and is a valuable<br />

reference resource for the future<br />

• Courses can be delivered on site so they suit<br />

shift patterns and availability<br />

Our Training<br />

Courses<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

Sterile Product Manufacture<br />

Sterilisation and Depyrogenation<br />

High Purity Water (WFI and PW)<br />

Critical Utilities<br />

Lyophilisation<br />

Introduction to Pharmaceutical<br />

Engineering<br />

Pharma Eng and GEP Trends<br />

Clean Rooms, HVAC and Filtration<br />

Process Risk Assessment for SAL<br />

Risk Assessment for Deviation Handling<br />

Bioburden Control and SAL<br />

Steam Quality Testing; Theory and<br />

Practice<br />

Project Engineering Systems<br />

Commissioning and Qualification;<br />

Annex 15<br />

Automated and Manual Visual<br />

Inspection (add after Lyophilisation)<br />

RABS, Isolators and VHP (add after Clean<br />

rooms, HVAC and Filtration)




North West Ireland<br />

Client needs<br />

The client had an extensive requalification<br />

programme for porous load and fluid load<br />

sterilisation processes on site. This programme<br />

required 54 man days per year of requalification effort<br />

as well as production downtime, yet sterilisation<br />

deviations were still an adverse trend on the site.<br />

The client needed to improve confidence and reduce<br />

deviations in the sterilisation processes on site. To<br />

deliver this, a comprehensive up skilling and training<br />

and competency assessment for everyone involved<br />

in the sterilisation process from Operations to QA<br />

Review was required.<br />

What we delivered<br />

Based upon site survey, discussions and analysis<br />

of the current approach we developed a series of<br />

training courses for the site.<br />

Each course developed was site and process specific<br />

so the actual loads, cycle design, autoclaves and site<br />

procedures were used in the training. This included:<br />

• 2 day Operations and QA Course<br />

• 3 day Engineering, Technical and Validation Course<br />

• 1 day additional Thermal and BI Validation<br />

Practices Course for the Validation and QA teams<br />

• Ongoing training support to develop 2 site SME<br />

resources on Sterilisation<br />

Each course was delivered with comprehensive,<br />

indexed course notes based upon actual site<br />

autoclaves and processes.<br />

A common feature of our training courses is that high<br />

quality colour and well indexed course manuals are<br />

delivered that serve as a reference tool in the future.<br />

Detailed competency assessments, ranging from<br />

operations multi choice questionnaire to written<br />

papers for the technical, validation and SME<br />

resource were developed. These demonstrated<br />

learning outcomes and the application knowledge.<br />

Certificates based upon this competency assessment<br />

were awarded.<br />

The results<br />

• Deviations linked to sterilisation processes fell<br />

dramatically<br />

• Operation’s involvement and understanding<br />

of the process identified many improvements<br />

linked to quality assurance as well as efficiency<br />

improvements.<br />

• The training in thermal and biological validation<br />

identified several opportunities for applying latest<br />

best practice and advancement in technology<br />

to simplify the qualification and requalification<br />

processes.<br />

The ROI<br />

Sterilisation related deviations were<br />

significantly reduced which was the<br />

primary objective of the work.<br />

Requalification workload reduced from<br />

54 man days to less than 30 man days<br />

through rationalisation and application<br />

of current best practice for qualification<br />

of sterilisation processes.

❝Whenever a company had a problem, Mark was the person<br />

to provide the solution, rather than just a temporary patch.❞<br />

<strong>MTL</strong> - Projects<br />

Stan O’Neill, Managing Director, The Compliance Group<br />

ASTM E2500 and many other recent standards and<br />

guidance documents require the proper application of<br />

Good Engineering Practice (GEP) and Subject Matter<br />

Expertise (SME) throughout Projects. Mark Thompson<br />

Lifesciences deliver this in a number of areas.<br />

Recent updates to Annex 15 of the EU GMP guide<br />

Projects undertaken<br />

also require a much more detailed and considered<br />

approach to process risk assessments, design<br />

qualification (DQ) and requirements traceability<br />

matrices (RTM) on projects. When applied properly,<br />

this approach delivers huge benefits to the quality and<br />

understanding of the delivered process.<br />


New Parenteral product<br />

Formulation and Aseptic Fill<br />

Finish facility<br />

Facility Expansion Project for<br />

Terminal Sterilisation Facility<br />

Sterilisation Process<br />

Improvement on Aseptic Fill<br />

Finish Facility<br />

New Filling Line in Parenteral<br />

Product Facility for both Aseptic<br />

and Terminally Sterilised<br />

Products<br />

New High Purity Water System;<br />

Generation Storage and<br />

Distribution for a 45m3/Hr High<br />

Purity Water System<br />

High Purity Water System<br />

Upgrade. 18MOhm water<br />

system generation storage and<br />

distribution<br />

Ireland<br />

Ireland<br />

UK<br />

UK<br />

China<br />

UK<br />

Consultancy Support and Project Guidance throughout including the<br />

Contamination Control Process Risk Assessment, URS development,<br />

Design Qualification and Requirements Traceability Matrix<br />

Consultancy Support to Sterility Assurance Risk Assessment and<br />

Qualification approach to Sterilisation in Place Processes<br />

Audit and Process Review to ensure regulatory compliance and<br />

identify action plans for process improvement. Training and<br />

development of site expertise and Subject Matter Expertise in:-<br />

• Sterilisation and Depyrogenation<br />

• Pharmaceutical Engineering<br />

• Steam Quality Testing<br />

Contamination Control and Cross Contamination Control Process<br />

Risk Assessment. Development of Validation Master Plan, Validation<br />

approach and scoping the qualification activities based upon Process<br />

Risk Assessment and Design Qualifications<br />

URS Development, Supplier Auditing, Design Qualification and<br />

Project support throughout Validation. This project run in conjunction<br />

with Crystal Clear Engineering, delivered and led by <strong>MTL</strong><br />

Consultancy support to scope the most appropriate project solution,<br />

URS Development and ongoing consultancy support. This project run<br />

in conjunction with Crystal Clear Engineering, delivered and led by<br />

<strong>MTL</strong><br />

Critical Utilities System Review Netherlands Aged Plant analysis and Critical Utilities Review in response to FDA<br />

observation<br />

Steriliser Upgrade Project to<br />

meet current GMP and EU<br />

standards for Sterilisation<br />

Processes.<br />

Pre US FDA Inspection of<br />

Aseptic Fill Finish Facility<br />

Biological Indicator Receipt<br />

verification. D value testing<br />

Bio burden Control and Micro<br />

biology control improvements<br />

Belgium<br />

India<br />

3 sites in<br />

Ireland and 1<br />

in UK<br />

Brazil<br />

Consultancy Support and Training for Upgrade Project. On site cycle<br />

development and air detector set up work<br />

Pre Audit inspection and consultancy support in preparation for first<br />

site FDA inspection<br />

Receipt verification of Biological Indicators is defined in USP and<br />

EP. Performing independent D value determination is problematic<br />

so many sites are changing to running a sub lethal cycle which is in<br />

full compliance with EP and USP requirements. Project and Change<br />

control assistance being supplied to drive through the change.<br />

Project Delivered for the Gates Foundation at a vaccine manufacturer<br />

in Brazil

❝Mark has led the provision of<br />

sterilisation related external advice<br />

and contracted service to our<br />

company in Cork, Ireland for over<br />

10 years. He and his team have<br />

always been well informed on the<br />

requirements but also pragmatic<br />

in how these could be delivered<br />

in a cost effective manner. They<br />

have always been flexible to tie in<br />

with company time limitations and<br />

have been reliable in the quality<br />

and timeliness of documentation<br />

produced. Mark has also been<br />

an invaluable source of ad hoc<br />

information to help support<br />

regulatory or inspection queries<br />

and to assist in the resolution of<br />

technical problems.❞<br />

Danny Healy, VP QA, Trygg Pharma<br />


+44 (0) 7780 430383<br />

enquiries@markthompsonls.com<br />


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