MTL - BROCHURE 2018 SINGLE PAGES

❝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