Gary Hartnett, Bausch & Lomb

Transcription

1 What we do

2 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

3 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.

4 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 system for regular updates on this.

5 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)

6 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.

7 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

8 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) enquiries@markthompsonls.com markthompsonls.com