GPN Services
- 1. Global Pharma Networks Services . . . adding value to your business
- 2. Global Pharma Networks New Pharmaceutical Start-up teams through this critical process. Our Over the past 20 plus years GPN SME’s* have expertise is based on our direct operational been involved in numerous new facility start- experience in the Pharma Industry and on Vision ups and expansions. In particular, we have our experience in designing and reviewing To use our been involved in the areas of planning and pharmaceutical plant operations. We seek to management of projects, validation and quali- maintain our knowledge of current regula- knowledge fication of both the facilities and the tions and regulatory authorities current and processes, compliance and regulatory readi- thinking on the future. Our approach to experience ness and the operational start-up of the design reviews is to look at the facility or facilities. site from a manufacturing, supply chain and of industry Site Selection compliance view point to ensure that the to leverage engineering solutions in the design align GPN has a defined and proven methodology sustainable for site selection.This is based on the expe- themselves with the requirements of the benefits for rience we have gained over the years and client’s staff, and those of a modern manufac- our knowledge of the local environment. turing and supply organisation.This ensures our clients that the material/process flows, regulatory Our experience in this field also means that we are in an ideal position to interface and compliance, safety, cost, and technology pro- coordinate with all the governmental and posed are considered and the impact on the regulatory bodies involved in this process. integrated project timelines assessed. We have been involved in this for a number Project Management of confidential clients. All GPN SME’s are proficient in the planning, Integrated Project Timeline managing, and execution of key business Integrated Project Timelines are a critical projects. Our SME’s have been involved in success factor for both new facilities and the planning and managing of multi-million expansions.The focus is to provide a clear dollar projects.These projects have included plan for facilities and operations start-up full site design and development, process right through to product launch.All the design, business process re-engineering, new other project plans (design, construction, val- product/ market introduction, compliance idation, process scale-up, process validation, evaluation upgrades, and both equipment, exhibit batches, regulatory, etc) are integrat- process and computer systems qualification ed into one cohesive whole . Risks, problems and conflicts are identified and solutions are Strategy Development proposed. GPN SME’s have over 20 years Developing a strategic plan is vital for both a experience in the development of integrated site, a division and a corporation. It provides timelines and what the issues that need to the vision and leadership for the develop- be resolved.This experience has been gained ment and success of the organisation. GPN in both new sites, and on expansions, and on SME’s have the skills and experience to help new product and process introductions to develop your facility and/or corporate strat- existing sites, in a number of countries. egy. The strategy will define the direction and GPNs experience can add value to the proj- roadmap for the next five years and identify ect planning and management process by incremental goals and objectives that facili- looking for and delivering savings. tates the achievement of those goals.This Facility and Project Design strategy document provides direction on site Review and facilities development, products to be GPN SME’s are expert in undertaking inde- made and those to be discontinued and sold pendent detailed design reviews and can lead off, technologies to be used in the future, *Subject Matter Experts
- 3. Global Pharma Networks capital expenditure budgets, quality systems participation in seminars, notifications, etc. It and standards, manufacturing systems and is useful to have an independent view on a standards, supply chain strategy, IT strategy, company’s operations on a regular basis to 3 pronged etc ensure compliance and to highlight areas for approach Supply Chain Operations improvement. to business GPN have experience across the complete The advantage of choosing the GPN auditing improvement Supply Chain from developing of the global group to do this is that: supply chain strategy, to the developing and GPN see many more companies operations . managing customer relationships, through and you get can benefit from this experience Use our manufacturing, to partnered supply from ven- GPN have professional auditors with dors. Our Supply Chain SME’s have worked industry experience and know where to knowledge to within materials, purchasing, manufacturing look for issues resolve the and distribution. In addition to direct experi- GPN can assist in identification of issues or ence of managing multi million dollar supply improvement ideas develop new lines our team is expert in the application of GPN can implement improvement ideas also processes modern supply chain systems. By merging GPN experts have views on the industry the application of the ERP and Shop Floor trends and ideas Control systems with the supply chain GPN are not constrained by internal . processes our SME’s can leverage improved company constraints customer service, streamlined manufacturing Teach the cycles and optimised inventory levels on site. Operational Improvement client GPN SME’s have a large amount of experi- team’s how ence in managing pharmaceutical operations. Quality Systems Development This experience has been obtained from to do this for Quality Systems are integral and vital to the working in senior operations management themselves successful operation of a pharmaceutical positions in some of the worlds leading - prevention manufacturing site.We can assist in the eval- Pharma Companies.We can use our skill and uation, modification, and transfer of quality of knowledge experience to support the existing operation systems from the parent operations (if this by reviewing the existing facility operations drain applies), and in the development and imple- and management practices and then provid- . mentation of new systems. We can facilitate ing direct support to the key daily opera- the system design discussions that will be of tions. Depending on the status of the opera- Automate benefit in ensuring that the direction of the tions this support can be provided in differ- the process work is the best possible to ensure that the ent ways.Where an operation is not current- where business and regulatory needs are met. ly successful our SME’s can leverage their possible When a new operation is considered it is experience to turn around poorly perform- always a chance to develop the best systems ing areas either by supporting the existing - long term based on experience and ensuring that the prevention team and management or by providing direct changing business and regulatory environ- leadership to the team.Where an operation of ment are taken in to account. is performing but needs to understand how knowledge Regulatory Compliance and well it could perform our SME’s can support drain Quality Auditing the team in the assessment of it’s perform- The Regulatory framework is constantly ance through benchmarking and gap analysis changing and it is important to get current to identify the risks, issues and opportunities information and a view on the emerging available to them. Improvements may be trends. GPN experts keep themselves up to required in quality, capacity improvement, date on these changes and issues through capital productivity, inventory usage, cost
- 4. Global Pharma Networks reduction, etc.This may be a large step management is a key discipline to the suc- change process improvement or a series of cessful start up and ongoing operation of a small changes.An improvement scheme facility. It provides the basis for the quality of would be defined with defined targets and a the product, the robustness of processes, the plan for how to achieve it. We would then stability of supply and facilitates the educa- implement the plan e.g. using Lean tion of the workforce.With our expertise we Manufacturing technology.Various tools could can plan and implement a multi-disciplined be used during the investigation or problem process to new product and process intro- resolution phases.A measurement system ductions that ensures a robust start up and would be installed. See also Continuous ensure that the training and education plans Improvement of the personnel on site are aligned with all Continuous Improvement of the technical requirements.This critical GPN has 20 years experience in the imple- area requires high calibre resources that are mentation and management of continuous competent on the products and processes improvement projects and programmes on that are being transferred. In addition to client sites. GPN SME’s make use of site understanding the processes GPN SME’s are resources and teams to get client engage- skilled in both problem solving and project ment in the continuous improvement management methodologies and as such can process. In this way the site personnel devel- provide a more effective and streamlined op ownership of the CI process and the skill approach to the transfer. and expertise to sustain the process on an Product Development and ongoing basis.As part of this process GPN Problem Solving can supply training in the standard analytical Problems do occur in plants. We can investi- tools commonly used to drive the continu- gate and help resolve product and process ous improvement process.This is the ongoing problems particularly for those nagging prob- process of continually upgrading your opera- lems that do pop up from time to time. tions.We could audit the existing facility Particular areas of expertise are powder han- operations and compare it to best practice.A dling, tablet technology, process improvement gap analysis will identify risk, issues and and quality related issues. It is very useful to opportunities. Improvements may be resolve issues before technology transfer to required in any area e.g. quality, capacity a new plant to prevent escalation of the improvement, capital productivity, inventory issues.The methodologies used will depend usage, cost reduction, etc. An improvement on the problem found and may incorporate scheme would be defined with clear targets some of those mentioned already of and a plan for how to achieve it. We would Brainstorming, Force Field analysis, Pareto then implement the plan using proven tech- analysis, SMED, Kepner Trego, Isikawa and niques e.g. Lean Manufacturing technology. Cause and Effect, Story boards, etc. Statistical Various tools could be used during the inves- analysis of data is important in this process tigation or problem resolution phases e.g. also. Brainstorming, Force Field analysis, Pareto Learning, Education & Team analysis, SMED, Kepner Trego, Cause and Development Effect, Story boards, etc. GPN’s strategy is for a 3-pronged approach Technology Transfer to the challenges of an organisation.This GPN can design the technology transfer approach can be summarised as management framework.Technology transfer
- 5. Global Pharma Networks USE our knowledge to resolve your issues it’s experience and network of associated and meet your challenges, companies to identify the most suitable TEACH the organisation the tools and tech- methods of sourcing appropriate candidates niques needed to continue this work on for positions their own System Application AUTOMATE/EMBED and integrate the tools GPN has a wide amount of skills and expert- and techniques into the site systems so that ise in the design, configuration and imple- the knowledge drain is minimised. mentation of all key business systems ranging Implicit in this strategy is the recognition from, ERP, LIMS, KPI reporting, Document that it is essential for an organisation to Management Systems, Knowledge learn and develop in order to achieve world- Management Systems, Bar Code Data class operations. In keeping with this GPN Collection Systems and MES systems.A key SME’s keep teamwork and development at challenge in implementing systems is in the forefront of all assignments. We do this selecting systems that add value to the in two ways. Firstly, our SME’s work with the processes on site as opposed to implement- organisation teams to impart the practical ing software functionality. GPN take a expertise to the team and secondly we pro- process orientated approach starting with vide a range of classroom courses through the identification of actual business process- our training SME’s to teach the organisation es on site, review of functionality and then the tools and skills that may be required to agree on optimised processes which are achieve their goals.This combination of theo- leveraged off the functionality available. ry and mentoring provides real support and aids the development of a team-based cul- Automation ture. It also facilitates passing on the knowl- GPN automation SME’s have in excess of 12 edge from our consultants to the client’s years experience in the design, development staff and is of significant long-term value. and implementation of process automation systems in the Pharma Industry. Our SME’s Organisational Design ensure that the strategic issues with automa- An integral part of the development of a tion are addressed as part of all assignments. new site, the introduction of a new product Such issues include standardisation of sys- or process or the re-engineering of an exist- tems and infrastructure, common methodol- ing business is the development of the ogy of design and qualification between all organisation itself. GPN has worked directly vendors. In addition all our SME’s are fully in the industry and we have direct experi- versant in the requirements of GAMP4 and ence of the various cultures and styles that 21CFR Part 11 and EU Annex 11 and are have been developed over the years. Based capable of undertaking compliance reviews on this experience we can advise on the on behalf of clients. most appropriate organisational structures in terms of headcount, reporting relationships, management systems, employee involvement and collaboration. In addition to this GPN has many links and associations within the 3rd level college community. Once the organisation has been defined GPN can use Global Pharma Networks 128 Lower Baggot St., Dublin 2, Ireland tel: +353 1 6392928 fax: +353 1 6392920 website: www.global-networksgroup.com email: sales@global-networksgroup.com © Global Pharma Networks and Profile Solutions Ltd.2003