m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s e x p e r t a d v i c e i n t r a c k & t r a c e, a u t h e n t i c a t i o n, r e g u

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2 Networking: the key to excellence Business Networking: making critical contacts within key organisations and companies. Key Senior managers within MENTOR have been responsible for developing networks within organisations or influential groups that can benefit your own companies interests, market understanding and positioning. Individuals have developed targeted & strategic networks of contacts in major global organisations, interest groups, work groups or even influencer groups to lobby for mutually beneficial market changes & understanding. U.S. Food & Drug Administration 2

3 Market & Requirements monitoring Regulation & Compliance issues: national, regional and global What Changes in legislation and regulation are planned or happening today - where, when, how? How will planned changes affect your business now and in the future do you have a strategy? Will these changes mean radical alterations to your future plans or can you handle them with your existing structure? U.S. Food & Drug Administration 3

4 representation Regulatory and Compliance Meetings, Conferences, Seminars, Workshops. Add weight to your company or organisations representation at important meetings Ensure that you understand the Key issues and can ask the right questions to protect your organisations interests Make sure you have experts at such meetings who can interpret the technical material and explain it s ramifications to internal groups or management teams U.S. Food & Drug Administration 4

5 Relationship Management Key Company b2b Use independent consultants such as MENTOR to ensure business-to-business relationships are maintained and developed including writing standards documents and recommendations to influential groups and bodies These may be within the same industry but across diverse disciplines or across a range of industries where individual interests may effect future business development Some may be for mutual benefit working together on interest groups, committees or industry bodies others may be strict inter-company commercial developments where an independent arbiter or broker may assist. 5

6 Track & Trace Development Project Design: pilots, trials, roll-outs We have expertise within MENTOR and access to individuals who designed, implemented and evaluated a number of the most significant pharmaceutical track & trace pilots and trials in recent years. (Irish Blood Derivatives, EU Bridge, MeditraQ Centre of Excellence (amongst others) We believe that no other organisation has access to such skilled individuals who are at the forefront of integrating track & trace developments within the pharmaceutical and related industries. 6

7 Track & Trace Development Line Evaluation Reports: One of the key First Steps in creating a Track & Trace solution that meets your companies present & future needs is to start with an evaluation of where you are today. Without this you will never be able to understand how to plan the various steps you will need to take to be successful. The Team at MENTOR have not only successfully developed trials and pilots to global industry standards but were the first and so far, the only group of individuals - to evaluate and analyse the existing product line and then write the URS, design, implement, install and operate a fully integrated, fully functioning, fully validated pharmaceutical production line to GAMP, ISO and 21 CFR Part 11 in

8 Track & Trace Development Line Evaluation Reports: This should be the first step in any Track & Trace Plan that will lead to mass serialisation. Understand where you are today and what you need to do to reach your objectives in terms of standards and compliance, timescales, budgets and resource allocation. Also remember that within all organisations that manage multiple production and packaging lines, no two lines are the same (similar but not the same) the first step should always be to evaluate individual lines and specific plants to check the physical situation and readiness for mass serialisation. 8

9 Track & Trace Development Line Evaluation Reports: Individual Evaluation Reports at this point will be more efficient and cost-effective than entering a major rollout phase without clear objectives, costs, resource implications, alternative solution options and compliance knowledge. New build, updating, refurbishing or retro-fitting may all be alternative solutions but out-sourcing, contract packing and sub-contracting may also be excellent options. What are the pro s and con s, who can and who will evaluate? 9

10 Track & Trace Development Software Integration Evaluation and Reports Similar in approach to Line Evaluation Reports - and may form part of those documents upon request - but at times Software Integration Evaluation and Reports will be a separate appraisal of how your software or the software you may be considering installing; not just hardware, stacks up in terms of meeting compliance and performance requirements. We work with real manufacturing and production line experts not people who specialise in middleware, MES, WMS, ERP but software systems that work on production & Packing lines to globally validated standards. 10

11 Track & Trace Development GAMP: Lifecycle Management Performance Test HW/SW Site Acceptance Test Interface Specification SW Instruction Inspection HW Design Specification Integration Test HW Integration SW Design Specification SW Integration SW Module Test SW Module Specification Coding 11

12 Track & Trace Development Product Evaluation - Hardware & Software based on GAMP Fit for Purpose what are the URS requirements Gap analysis what are the gaps and their priorities Performance speed, quality, integration Compliance conformity Regulatory, URS, SDS, FDS, 21 CFR Part11, GAMP, ISO Evaluation Reports Lifetime support analysis and traceability 12

13 Track & Trace Development RFP, RFQ, URS Writing, analysis and development Once the initial Line Evaluation and Software Integration Evaluation Report has been completed and understood i.e. Where are we today? You can begin looking at where you need to be in the future to meet current and planned compliance requirements. 13

14 Track & Trace Development RFP, RFQ, URS Writing, analysis and development One of the most vital elements is to have a precise and complete description of what any finished solution will look like and there may be more than one in different parts of the world or for different product types. The ability to understand how a solution will look is critical to the future design and implementation phases. It is therefore important to have advice from experts who have built such solutions in order to prepare a URS to meet GAMP/FDA/ISO requirements for pharmaceutical production and packaging lines. 14

15 Track & Trace Development RFP, RFQ, URS Writing, analysis and development Also, having built a number of different types of line the experts at MENTOR can advise on technical, performance and standards issues from a practical not just a theoretical standpoint. Remember, a number of the members of the MENTOR team are working on standards and compliance developments for major global organisations and regulatory bodies 15

16 Track & Trace Development SDS, FDS, RA Evaluation Once a URS has been written and distributed to start the tendering process it is important that the replies that are received in the form of SDS (Software Design Specification) and FDS (Functional Design Specification) and a RA (Risk Analysis) You may sub-divide this into different hardware and device elements you will need to ensure that any proposed replies are capable of meeting the original URS requirements. It is often at this point that variations, exemptions and alterations are added that can materially affect the final solution. You may need specialist advice and assistance to handle these points. MENTOR offers a GAP analysis including a traceablility matrix to seemlesly integrate into your validation documentation. 16

17 Track & Trace Development SDS, FDS, RA Evaluation Report evaluation, analysis and comments can be supplied as part of the professional services on offer from MENTOR. Going forward, the implementation of a detailed URS-driven solution will form the crucial part of the first line installation that usually precedes a full rollout, making sure that all suppliers fully understand the solution and how it works will be vital again MENTOR can assist not only in analysis of formal written replies to the URS but also in briefing, advising and training suppliers where necessary on behalf of customers. 17

18 Track & Trace Development Validation of Projects, Processes and Implementation One important issue that must be borne in mind as a company begins to work through this process is that any solution that results must be capable of being validated. This does not just mean individual pieces of hardware or devices but the complete process in all disciplines as many of these solutions will involve integrating a variety of hardware with software and different processes the finished result will need to be validated to meet a number of industry compliance standards, once again MENTOR can offer the skilled and qualified teams to undertake such specialist work. 18

19 PROJECT MONITORING & MENTORING Updates regular meetings with presentations, updates on above Part of the work of MENTOR will be to ensure that once plans have been agreed and contract signed, regular reports and updates will be provided. Some via internet support but others by briefings, meetings and seminars to discuss progress, problems, schedules and budgets. 19

20 Communication Services Press representation articles, features Much of the work that will be undertaken as part of any mass serialization project will be cutting-edge and innovative. Such work can and will generate serious interest throughout the industry both internal (other departments, divisions, plants) and external (customers, competitors, media, influencers) and as such will need to be handled with care. Much of the work on pilot and Trials such as Irish Blood and EU Bridge as well as MeditraQ was managed by members of the MENTOR team and again this expertise can be made available as part of any on-going contracts. 20

21 Communication Services Press representation articles, features One other crucial factor from an internal point of view and for training and record purposes is to undertake regular communication updates (video, interviews, documentation) of what happened at each stage and record successes as well as problems and issues that will need to be identified and possibly remedied for the future. 21

22 Communication Services Presentation material support for sales & commercial/video Material collected can be used to support commercial, training and information provision across the organisation and be used by representatives to deliver the corporate message at internal and external meetings, conferences, seminars and workshops. 22

23 Communication Services Education & Training - Training - internal/external It will be important to learn from the experiences that implementing a mass serialisation solution for track & trace will offer. Gathering information and data, learning from experiences may be vital to future success. This will have both internal and external benefits, reduce costs, reduce wastage reduce duplication of effort. 23

24 BAR CODES, RFID, AGGREGATION In the beginning. The first product ever scanned was a ten-pack of Wrigley Juicy Fruit Chewing Gum at Marsh Supermarkets, Troy, Ohio on 26th June 1974 and it was marked with a UPC-A bar code. 24

25 Communication Services Education & Training Master classes Expert lectures and education modules on: Mass Serialisation Track & Trace Systems Global Compliance Requirements - Country by Country Major Pilots and Trials Irish Blood EU Bridge How to set-up a meaningful pilot setting objectives, design, costing and implementation Case Study - Global first fully integrated, fully operational, fully validated pharmaceutical packaging production line - MeditraQ: Centre of Excellence Code Generation, aggregation, usage, storage RFID, technical, applications, appropriate usage Data Matrix as RFID Linear Bar Codes Data structure in code carriers Aggregation 25

26 Communication Services Regulatory Development: As Mass Serialisation is adopted Further, new regulations will be necessary to cope with technical changes and industry demands New Standards will also need to be put in place or updated to cope with individual rather than generic level track & trace. Will you be involved in the groups that shape and understand these changes or will you simply follow and apply whatever the standards bodies decide? Hybrid multi-carrier labels at case & pallet Item level unique 21 CFR part 11 standards will need to written and adopted. 26

27 Charges & Fees Retainer based on a mixture of services, based on daily rate. Project fees based on putting together very specific teams with skills to meet individual objectives and requirements. Based on successfully completed milestones. 27

28 Contact Details: Tony Walsh, Mentor Pharmaceutical Consulting, 53 Welland Place, Ely, Cambridgeshire CB6 2XA UK Tel: +44(0) Mobile: +44 (0) Web site: Some of the material shown herewith was created while working for: Domino Printing Sciences, Control Pharma or on behalf of Markem, EU Bridge and other organisations. Reference to Mentor Pharmaceutical Consulting in no way infers or implies that this presentations was given on behalf of Mentor or that any of the organisations shown are customers of Mentor at this point. These are organisations that members of Mentor have worked with and for over recent years. 28