Pharma And Biotech Brochure 2009


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SNC Lavalin Pharma and Biotech Brochure

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Pharma And Biotech Brochure 2009

  2. 2. 1. CORPORATE OVERVIEW SNC-Lavalin Pharma (SLP) is a leading global engineering, procurement, construction, validation, compliance and related technical services organization serving the biotechnology and pharmaceutical industries, life sciences organizations and the institutional sector. SNC-Lavalin Pharma has a global responsibility for the Bio-Pharmaceutical sector within SNC-Lavalin Inc. SNC-Lavalin Inc. (SLI) is one of the world’s largest groups of engineering and construction companies as well as a major player in the ownership of infrastructure and operating & maintenance services. With offices in 34 countries, SLI is currently working on projects in over 100 countries around the world. As one of SNC-Lavalin’s divisions, SNC-Lavalin Pharma is part of an integrated worldwide network of 18,000 highly qualified employees. SNC-Lavalin Pharma offers services that meet the needs of the biopharmaceutical industry, which include the design, implementation and validation of projects involving research, manufacturing and support facilities. We offer these services from offices in Philadelphia, Montréal, Quebec, Toronto, Calgary, Brussels, Lyon and Mumbai, which represent an international network of over 700 specialists. These specialists have a solid base in engineering, validation and project execution and are capable of developing novel and creative leading edge solutions based on industry needs. These professionals are specialized in servicing the pharmaceutical and bio-technological companies and can provide the full spectrum of services from preliminary studies to process validation. SNC-Lavalin Pharma has assembled a highly qualified and experienced group of resources represented in areas of major pharmaceutical and biotechnological activities. Growth has come from both organic growth and from partnering activities integrated into one industry-focused group. Using a flexible organization approach and virtual office systems, specialized resources from around the globe can be brought to bear to a project in any region. SLP is made up of the following members: • LKM Engineers, Toronto and Sudbury, ON • Pellemon, Montréal, QC • Wiebe Forest Engineering, AB • Sogequip, Lyon, France • Coppée-Courtoy, Brussels, Belgium • Pipecon Consultants Pvt., Mumbai
  3. 3. With the expertise of our qualified staff, many of whom have industry experience, we can tailor our services to ensure the satisfaction of our clients. In this context, and with the experience of our centres of excellence, we are well equipped to offer the following individual or integrated services: • Process Architecture • Facility Engineering • Process Engineering • Process Automation • Design Visualization • Robotics • Validation & Compliance • Project Management • Procurement • Construction Management All SLP offices are linked through sophisticated information technologies, allowing a seamless transfer of documents and information. This ensures that the Project Team will have easy access to all required information wherever they are located.
  4. 4. 1.1 SNC-LAVALIN PHARMA AND THE BIO-PHARMACEUTICAL INDUSTRY SNC-Lavalin Pharma’s desire to be involved in biotech and pharmaceutical projects has its source in the fact that SNC-Lavalin Pharma’s engineers recognize that the needs of the pharmaceutical industry’s engineering systems are among the most challenging in terms of sophistication and complexity. In order to maintain a leading edge in high tech building and process technologies, SNC-Lavalin Pharma recognizes its own need to invest in R&D in this field, as is the case for the pharmaceutical industry in its own fields of expertise. As a consequence, SNC-Lavalin Pharma is following in the footsteps of the pharmaceutical industry and has started what it considers to be a very innovative building technology R&D plan that revolves around two major poles: − SNC-Lavalin Pharma’s role as founding partner in the Central Canada Chapter of the ISPE (International Society for Pharmaceutical Engineering). − SNC-Lavalin Pharma’s role as founding partner in the Canadian Chapter of A3P (Association for Clean and Sterile Products, based in Europe). − SNC-Lavalin Pharma’s role as an affiliate member of IRPI (Institute for Research in Industrial Pharmacy). − Active participation of our staff in industry forums, technology-related panels and similar functions in life sciences sectors. Through a very proactive presence in these organizations, SNC-Lavalin Pharma is significantly investing in terms of time, energy and financial resources and recoups solid technical training and a better global understanding of the pharmaceutical industry’s design and compliance needs and requirements. As the pharmaceutical industry has clearly demonstrated in the past with its massive investment in R&D, SNC-Lavalin Pharma strongly feels that its future success and survival directly depend on these R&D efforts, in addition to creating strategic alliances with the pharmaceutical industry.
  5. 5. 2. TECHNICAL EXPERTISE For twenty years, SNC-Lavalin Pharma has carried out numerous projects for biotechnological and pharmaceutical industries as well as for hospitals and government agencies. These include R&D laboratories, manufacturing/production areas, in particular pertaining to solid dosage (granulation and compression), coating columns, fluid bed dryers, production of antibodies, solvent tank farms, liquid production lines, etc. SNC-Lavalin Pharma has thus developed a dedicated team of specialists with current expertise in the process design, facility engineering and validation of the sophisticated systems usually required in such facilities. These requirements reflect the industry’s needs to create, control and monitor, among others, the environmental parameters (temperature, humidity, pressure, ventilation, filtration) while ensuring the safety of researchers, operators and other workers as well as adequately confining associated chemical and biological contamination risks. Our frequent and close collaboration with the engineering departments of our pharmaceutical and biotech clients has given SNC-Lavalin Pharma the opportunity to acquire a thorough understanding of the specific and challenging needs of research as well as production, in addition to the requirements of the authorities having jurisdiction (FDA cGMPs, TPP cGMPs and GLPs, Sanitary 3A, CSA, NFPA and FM/ULC). This understanding has also included a very close collaboration, on a number of our mandates, with inspectors from the American FDA, the British MCA as well as from the Therapeutic Products Programme (TPP) of Health and Welfare Canada, for the validation of facilities, systems and equipment.
  6. 6. 2.1 KNOWLEDGE OF APPLICABLE STANDARDS AND REGULATIONS SNC-Lavalin Pharma’s expertise more particularly cover the standards usually applied to the design of pharmaceutical production and research centers and laboratories, including sterile facilities and injectable handling systems, which must be certified by the FDA and the TPP, as well as meeting the current good manufacturing practices standards (cGMPs) published by the Code of Federal Regulations (Chapter 21) for the United States and by Health and Welfare Canada. The interpretation of these GMPs, which are regularly published in the Code of Federal Regulations, is also of interest, as the standards are constantly updated in order to meet new industry requirements. The rapid evolution of the good laboratory practices (GLPs) applicable to research facilities’ activities is also very closely followed by SNC-Lavalin Pharma. The members of SNC-Lavalin Pharma’s pharmaceutical and research facilities project teams are all well aware of the importance of proper interpretation of these standards and of their constant evolution due to the changing needs of the industry, but also to the availability of new technical solutions. This is why a constant effort is made by SNC-Lavalin Pharma to improve its level of awareness in this field; this is done by means which include technological transfers and training, including attending educational seminars set up by ISPE North America and European branches, as well as direct consultations with US-based experts specialized in the validation and certification of pharmaceutical systems. Regulations regarding the confinement of biological hazards are also of utmost importance as they define several basic criteria to be met by electromechanical systems and important architectural elements of buildings where products with potentially high risks of biological contamination are handled. Policies concerning bio-safety in laboratories, as published by the Center for Biological Diseases of the US Department of Health and Human Services and the Laboratory Center for Disease Control of Health and Welfare Canada, strictly govern this matter. Similarly, the regulation published by the Atomic Energy Control Board (document R-52) states their guidelines concerning the handling of elementary and intermediate radioisotopes in a laboratory. Our process automation personnel is bound by our internal procedures (our quality manual is available for on-site review) and these reflect, where relevant, ANSI/ISA-S88.01 and GAMP standards. As for animal facilities, the standards and requirements stipulated by the Canadian Council on Animal Protection (Manuals on Care and Use of Animals for Experimentation, volumes 1 and 2) serve as reference.
  7. 7. 2.2 THE SYSTEM LIFE CYCLE APPROACH The System Life Cycle approach was developed by the biopharmaceutical industry in recent years. At SNC-Lavalin Pharma, we have developed our own version of the System Life Cycle (SLC) approach in the last few years and we continue to adapt it in order to better serve our biopharmaceutical clients. The System Life Cycle breaks down the project into three majors phases, made up of a total of nine steps, which are common to all projects. The SLC involves not only the A/E firm but all the stakeholders for the project. In fact, even if SNC-Lavalin Pharma is not directly involved in all the steps of the SLC, we try to give the best input possible to our Client to ensure a smooth transition from one phase to the other. The scheduling phase is split into three steps: an opportunity study, a feasibility study and a study of variables. It is during the scheduling phase that the major issues need to be discussed and resolved. Any major issues that are missed in this phase could have a significant impact on the financial or technical viability of the project. The realization phase is split into four steps: basis of design, detailed design, procurement and construction. Obviously, this is where SNC-Lavalin Pharma has the biggest impact on the project and where we would put a lot of effort into guaranteeing the best A/E and CM services to our Client. The operation phase is split into two steps: installation and operation. It is in this phase that some of the most critical steps of the validation are completed. The last step, operation, normally has no end point and is managed by our Client on a continuous basis.
  8. 8. 2.3 KNOWLEDGE OF SPECIAL SYSTEMS AND ELEMENTS SNC-Lavalin Pharma’s specialized expertise results in extensive familiarity with the standards and best practices used in the pharmaceutical industry for the following areas: Layout planning Special planning of corridors, loading and unloading docks, production, storage and packaging rooms and of their location, as well as the careful planning of doors and room access allows for the optimal use of areas for handling and circulation of raw material, semi-finished, finished and packaging materials, equipment and personnel, animal circulation (clean-dirty corridors concept) while meeting production needs and avoiding cross-contamination. Research facility characteristics also include a high level of M/E content thus creating a significant need for M/E equipment room areas, a higher floor-to-floor height, a lower building net to gross area ratio, and a need to coordinate locations of M/E rooms so as to limit the possibilities of effluent reingestion. Process and Automation When it comes to production skids, the scope of services for the design of process and automation engineering includes process flow diagrams (PFDs), piping and instrumentation drawings (P&IDs), general arrangement drawings (GAs), process equipment specifications (bid package, bid analysis and recommendations) and automation specifications (instruments, instrumentation and mechanical equipment index, control loop diagrams, layout drawings, installation details and interconnection drawings). Process and automation expertise in the pharmaceutical industry covers process skids, process utilities, environmental systems, and clean-in-place (CIP) systems. Process skids include solvent tank farms, aqueous and solvent solutions for coating and granulation, fluid bed dryers, coating columns, liquid production lines, packaging and filling lines, etc. Process utilities include USP purified water, compressed air, nitrogen blanketing, process steam, clean steam, process air conditioning, hot and cold water, etc. Environmental systems include spill containment and waste solvent collection measures, measures against solvent vapour emissions, decontamination systems, etc. Clean-in-place (CIP) systems include production, storage, distribution and recovery (and recycling) of cleaning solutions, from simple systems such as wash-in-place (WIP) to clean-in-place (CIP) and finally, sterilize- or steam-in- place (SIP).
  9. 9. The integration of liquid process services with process skids in the fixed furniture is also a key element for flexibility. Water systems Recognizing the acute need of the industry on this matter, SNC-Lavalin Pharma has acquired solid expertise in the design, construction and validation of water treatment systems and water distribution networks producing water-for-injection (WFI), USP purified water, and laboratory quality demineralized water, using a combination of multi-layer filtration, water softening, 5 micron filtration, chlorine removal, distillation or reverse osmosis process, deionization (mixed bed or continuous), U/V sterilization and final filtration to achieve both the chemical and the bacteriological water quality required by the client. The right selection of piping material, welding methods, network cleaning, jointing and erection methods, temperature conditions, minimum flow rates and velocity to be maintained for these networks are all parameters that must be controlled to achieve acceptable results. Environment systems Ventilation and air conditioning systems are designed to create a clean and/or aseptic environment, free of contamination, to meet the requirements of the industry and the applicable norms. Air filtration levels and the creation of clean rooms of classifications ranging from 100,000 to 100, using HEPA filters, are of the utmost importance to produce such an environment. In order to maintain the quality of this environment, the systems must be able to control and monitor the following parameters: room-to-room relative pressurization levels, air circulation flow rates, temperature and relative humidity. Essential requirements for validation and certification of these facilities are that all of the above parameters be recorded and documented. Fume hoods and biological safety cabinets, and their arrangement in efficient systems capable of guaranteeing the scientists’ safety and health while ensuring an energy-efficient system, is a major issue in a state-of-the-art, energy-efficient research facility. Dust control The control of dust and particle emissions resulting from production processes requires the installation of dust recovery systems integrated into ventilation and air conditioning systems. This integration may be required to maintain the pressure at differential levels even when the dust collector systems are not in operation. House vacuum systems are also normally required for the periodical cleaning of equipment and of the rooms themselves.
  10. 10. Effluent treatment Liquid and gaseous effluent treatment systems (such as neutralization, disinfection and filtration systems and kill tanks (sterilization)) are required by regulatory authorities (Environment bodies, municipalities) and codes and standards for the protection of the environment. Room finishes The quality of room finishes and the methods and details used for their construction, ease of maintenance and cleaning, i.e. no holes or cracks may be visible in the finish, and all surfaces must be sealed. These surfaces must be hard, smooth and free of sharp edges where dust could accumulate; all protruding elements in the rooms must be easily cleanable. The impact of these requirements on the visible elements of electromechanical systems must be considered in their selection, for proper integration into the overall building. The high sealing efficiency of the partitions (walls, ceilings, floors) required to maintain the pressure differential rates needed between adjacent rooms has a direct impact on the selection of building, structural and architectural systems. Special sealing systems are sometimes required as a remedy to existing conditions. Safety issues The safety of scientists and other personnel is a very important aspect of the global design of research centers. Key elements include the following: • location of means of egress for scientists with respect to the most probable sources of danger (solvent concentration, fume hoods, etc.); • location of ventilated solvent storage cabinets; • fume hoods and biological safety cabinets; • eye wash and emergency shower water networks and locations; • solvent storage rooms and explosion venting; • high solvent content room partitions, explosion rating design and explosion venting panels; • sprinkler and fire cabinet locations; • electrical classification (intrinsically safe systems, explosion-proof areas, etc.); • HAZOP (hazardous operations, interlocking, emergency stops, etc.). Access to electrical and automation systems Easy access to electrical and automation systems and control elements for maintenance, calibration and replacement is a key element which must be considered in design. Explosion-proof rooms, types of ceilings, types of easy
  11. 11. cleaning access panels, and their integration into the buildings are all elements that require particular attention when designing these sophisticated facilities. Flexibility This word has a very special significance for pharmaceutical production and research facilities. With the fast-growing rate at which production and research can evolve, systems must be designed so that they can still meet the industry needs in the future. Communication Process and building communication networks for voice and data are now included in state-of-the-art research and manufacturing facilities. Emergency and UPS Emergency power supplies for research systems as well as for environmental systems are now more and more contemplated in research facilities and include static uninterruptible power supplies (UPS) for process automation. Building control and monitoring systems for process automation Recent computer technology combined with industry needs has dramatically changed the building control integration level in facilities. SNC-Lavalin Pharma takes pride in the fact that all control and automation design for all above-listed systems is done in-house by SNC-Lavalin Pharma’s own team of control and building automation experts. 2.4 CONSTRUCTION MANAGEMENT/GENERAL CONTRACTING As construction manager, SNC-Lavalin Pharma can become the Owner’s representative and manage all field construction activities. This includes responsibility for the construction methods, techniques, sequences, procedures, costs, schedules, quality and warranty of the construction work. To accomplish this construction work, SNC-Lavalin Pharma will bid and award contracts to pre- qualified and approved subcontractors for all segments of the work on a competitive bid basis. SNC-Lavalin Pharma is directly accountable to our client for all construction and other items relating to the construction of the facility. During the construction phase of the project, we coordinate all activities to develop an orderly, controlled construction effort within the agreed time frame. Our capability in management, engineering, budgeting, cost estimating and control, scheduling, purchasing,
  12. 12. inspection and labor relations is fully utilized to ensure the successful achievement of the project objectives. PM+ ® , SNC-Lavalin’s proven Project Management system, is a professional delivery service encompassing everything needed to plan, design and construct a facility with one source directly accountable to the client. The specific benefits of TPM are: • Single-source responsibility • Reduced administrative burden • Early cost determination and control • Reduced financial risk • Schedule compression Projects are managed by a single individual who has total project responsibility. This improves coordination and communication from project conception to completion. The Project Director is ultimately responsible for the delivery of all aspects of the project, and is the focal point for project information distribution throughout the assignment. This Director manages all project resources and facilitates communication between the client and the team of professionals. PM+ ® allows the design and construction phases to operate as independent professional organizations; integrated through the Project Director and providing an optimum balance between design and construction considerations. Contractual options are tailored to the individual owner’s needs and ensure delivery within budget, schedule and quality requirements. SNC-Lavalin Pharma’s ability to meet owner schedule and budget requirements is enhanced through our project management and reporting systems which provide our project managers with timely information. 2.5 CONSTRUCTION SUPERVISION, START-UP ASSISTANCE The engineering construction scope of work includes bid packages (specifications, standards and drawings), construction management (construction work, schedule, supervision of process skid installation and shop drawing approval) and assistance upon start-up operations (training sessions, documentation required for IQ/OQ validation, automation system debugging and as-built drawings). Construction work supervision is of prime importance, ensuring the optimum quality of facilities. A high level of sophistication of systems and finishes requires constant follow-up and monitoring, allowing good construction work progress and quality that meets specification requirements.
  13. 13. System start-up, balancing and calibration are essential parts of the project as they will allow subsequent installation, operation and performance qualifications (IQs, OQs, PQs) to take place, if required, as well as to gather required documentation for validation. SNC-Lavalin Pharma’s team can provide on-site supervision as well as assistance upon system start-up. Our recent experience in projects involving production and research centres shows the importance of the presence of the design team members on-site upon electrical and automation system start-up in order to be able to assist the various contractors break in the state-of-the-art systems. 2.6 QUALIFICATION AND VALIDATION The preparation of documentation proving to regulatory agencies that the facility conforms to cGMPs is an important issue in the industry. Every integrated validation process starts with the preparation and implementation of a validation master plan early on in the design phase; this plan carefully defines and documents all procedures and activities which have an impact on the process. The preparation and early submittal of the validation master plan to authorities having jurisdiction (TPP and FDA) allows the Owner and the authorities to reach agreements in principle early in the project. It also allows design deficiencies to be detected and corrected. To this end, close collaboration between the Owner’s representatives and SNC- Lavalin Pharma’s team is required in the elaboration of the validation master plan, IQs, OQs and PQs as well as Standard Operating Procedures (SOPs), and their integration as a whole into all other elements which form the overall plant master file (equipment data sheets, calibration procedures, preventive maintenance programs, change orders). SNC-Lavalin Pharma is proud to offer the pharmaceutical industry a complete range of validation services for building and process systems.
  14. 14. 3. PERTINENT EXPERIENCE – DESIGN Total Cost Year Genzyme Corporation New Biotech Production Facility, $142 M 2010 Lyon, France Actavis Suite 3 Project N/A 2008 BD Diagnostics GeneOhm New Medical Device Research and $20 M 2008 Manufacturing Facility Converted Organics First Biostimulant Production $14.5 M 2008 Facility – CM services Wyeth Consumer Healthcare Renovation of Laboratories, $8.5 M 2008 Buildings 11 and 14 AstraZeneca Chemistry Labs Expansion, $5 M 2007 Montreal R&D Centre G+G Partnership Architects New Toronto Centre for $69 M 2007 Phenogenomics (TCP) GSK Biologicals SF Facility Production Upgrade N/A 2007 GSK Biologicals New Quality Control Laboratory, ∈120 M 2007 Belgium Guerbet, France Injectable Active Substance Facility ∈5 M 2007 Kasian Architecture University of Calgary – Child $23 M 2007 Development Centre (LEED Platinum Certifie ) Merial, France Monolayer III Project: Global basic ∈30 M 2007 design & process achievement engineering Novasep, France Biotechnology Facility ∈10 M 2007 OPP Forensic Facility CL3 (Containment) Lab Facility $1.1 M 2007 Sandoz Major Expansion - Sterile $40 M 2007 Production Plant Sanofi Aventis, France New Warehouse ∈10 M 2007 Wyeth Research SmartLab 1 Upgrade, Building 5 $4M 2007 Biovail Steinbach Facility Expansion $27.5 M 2006
  15. 15. Total Cost Year CNRC, Industrial Materials Nanofabrication Clean Room and $3 M 2006 Institute Prototyping Centre Development Flamel, France Micro-pump Pilot ∈20 M 2006 New Pharma Production Facility GSK Biologicals Expansion and Retrofit of QC, New $51 M 2006 Shipping fit-out and New Seed Preparation Areas GSK Biologicals Expansion of Production Area $50 M 2006 (Option 5) – partial design services NUCRYST Pharmaceuticals API Production Facility Renovation $2 M 2006 Pdi Pharma GLP & cGMP Facility for $4.8 M 2006 Pharmaceutical Testing (over 15,000 SF of R&D pharmaceutical labs) Pfizer Consumer Healthcare New Global R&D Laboratory $3.2 M 2006 (relocation) Roche Diagnostics Inc. Expansion of Existing Offices $6.5 M 2006 Sanofi Aventis, France Logistic Building Restructuring ∈10 M 2006 Sanofi Pasteur New Research Vivarium $18 M 2006 Taro Pharmaceuticals GLP Labs, Validated Production $3.6 M 2006 Facilities Infrastructure and Service Upgrades Trent University DNA Cluster Project, including New $20 M 2006 BL3 Laboratory AstraZeneca OAZis Cafeteria Extension at $1 M 2005 Montreal R&D Centre Cephalon, France Pharmaceutical Chemical Unit ∈24 M 2005 Charles River Labs Buildings 7 & 8 – Safety $20 M 2005 (previously CTBR) Assessment Lab Complex Dermik Laboratories Lab and Office Renovation $1.7 M 2005 GSK Biologicals, Belgium Live Viral Vaccine Facility ∈44 M 2005 GSK Biologicals Renovations to Building 15, $13.5 M 2005
  16. 16. Total Cost Year (recipient of Leonardo Award) Nicholls Yallowega Belanger Northern Ontario School of $17 M 2005 Architects Medicine – Northeast Campus Pharmacy Faculty and IRIC New Pharmacy Faculty and new $84 M 2005 Research Institute Immunovirology & Cancer Research Institute Phyton Biotech Lab and Office Renovation $2.1 M 2005 Therakos Laboratory and Office Renovation $1.6 M 2005 Veterinary Medicine Faculty Veterinary Medical Center and $57 M 2005 – St.Hyacinthe Institute of Veterinary and Food Biotechnology Baxter Healthcare Equip Prep Area Sterile Facility $4.7 M 2004 Centocor Cell Banking Facility $4.7 M 2004 DSM Biologics LSE – Large Scale Expansion $140 M 2004 (Design completed, not built) Lorus Therapeutics Clean Animal (Vivarium) Room $1 M 2004 Facility – FDA Approved McMaster University DeGroote Centre – Centre for $65 M 2004 Molecular Medicine & Health Novocol Phase 2 – New Bosch Filling Line $9 M 2004 Pfizer Manufacturing Renovation at Lilitz N/A 2004 Facility Sanofi Aventis, France Cytotoxic Pilots (2 projects) ∈15 M 2004 AstraZeneca Utilities Upgrade $7 M 2003 Centocor 3000 SF GMP Pilot Plant $3.6 M 2003 Concordia University Loyola Science Faculty $64 M 2003 Hemosol HemolinkTM Commercial Production $57 M 2003 Facility McGill University Montreal Genomics and Proteomics $20 M 2003 Center
  17. 17. Total Cost Year MDS Nordion Kanata Radiopharmaceutical $30 M 2003 Manufacturing Facility Merck Frosst Building 9-2 South Fit-out Project $10 M 2003 Merck Frosst Building 10 – North Extension $30 M 2003 Novex Pharma BFS / Compounding Upgrade $10 M 2003 Provincial Government Quebec Public Health Laboratory $10.2 M 2003 including BSL3 Lab GSK Biologicals, Belgium Production, Filling & Packaging of ∈8.8 M 2002 Human Vaccines Hema-Quebec New Laboratories for Blood $19 M 2002 Processing Facilities Novocol Sterilization & Plant Upgrade $2 M 2002 Sandoz Sterile Production Facility $4 M 2002 DSM Biologics ML-31/ML-51 Fit-out $7 M 2001 Merck Frosst Bldg 18 – Office building $35 M 2001 Merck Frosst Bldg 9 – 1st Floor Renovation $16 M 2001 Novocol Ph.1 – Sterilization & Plant Upgrade $2.8 M 2001 Valigen Renovation of 80,000 SF for a New $9 M 2001 Biotech R&D Facility Charabot, France Raw Material Production Facility ∈11 M 2000 for Perfumes Johnson & Johnson Plant Expansion Project $19.6 M 2000 Merck Frosst Bldg 19 – PR & D Expansion $45 M 2000 Merck Frosst Bldg 9 – 2nd Floor Renovation $17 M 2000 Merck Frosst Bldg 9 – 2nd Floor Project – $4 M 2000 Research Administration Merck Frosst Bldg 17 – New Quality Control $12 M 2000 Laboratory Facility Novartis Interior Renovation Project $2.3 M 2000
  18. 18. Total Cost Year Aeterna Laboratories New Biotech Production Plant $16.5 M 1999 Draximage Lyophilisation Extension $8 M 1999 Galderma Production Cream & Ointments Manufacturing $22 M 1999 and Packaging Facility Laboratoires 3M Santé, Pharmaceutical Preparation Facility ∈18 M 1999 France for Aerosol Production Merck Frosst Bldg 10 – Third Floor Fit-out $14 M 1999 Novartis Production Renovation & Additions $10 M 1999 Pfizer West Building $12 M 1999 Roberts Pharmaceuticals Design of New Sterile $10 M 1999 Manufacturing Facility for Liquids Apotex Renovation of Laboratories $1 M 1998 Merck Frosst Production Area Modernization $83 M 1998 Astra Pharma Rommelag 321 Expansion $2 M 1998 Astra Pharma Liquid Preparation Expansion $0.6 M 1998 National Research Council Biotechnology Research Institute – $20 M 1998 Expansion Genpharm Process Optimization $1.2 M 1998 Glaxo Wellcome Mepron Malarone Production $4.5 M 1998 Novartis Plant Upgrade $8 M 1998 Pasteur Mérieux Connaught Component Pertussis Program (CP) $13 M 1998 ProMetic Pharma Plant Renovation $5 M 1998 Canadian Red Cross Relocation of Transfusional Services $2.5 M 1997 Center Connaught Labs BCG Facility $14 M 1997 Genpharm Inc. Process Engineering $1.2 M 1997 Glaxo Wellcome Inc. R&D and Manufacturing Facility $120 M 1997 GSK Biologicals (formerly Flu Vaccine Production Plant $22 M 1997
  19. 19. Total Cost Year Biochem Pharma) Martec Pharmaceutical Hormone Granulation $6 M 1997 McNeil Pharma HVAC Upgrade for Consumer $0.25 M 1997 Products Plant Merck Frosst High Shear Mixer Facility $0.3 M 1997 Merck Frosst Building 9 - Small Scale GMP $1.2 M 1997 Facility Nordion International HVAC Upgrade, Phase I $0.7 M 1997 Novartis Pharmaceutical Modifications to Dorval and Whitby $0.2 M 1997 Corporation Plants ProMetic Pharma Process Flow Diagrams $0.5 M 1997 Ratiopharm (formerly Upgrade of HVAC Systems $1.2 M 1997 Technilab) Sanofi Aventis, France SAPHIR Project: Fine Chemical and ∈60 M 1997 Pharmaceutical Units Schering Evaluation of Purified Water, Pure $0.25 M 1997 Steam and WFI Systems Astra Pharma Pharmaceutical Research Center $23 M 1996 Bio-Intermediair New Biotech Production and $15 M 1996 Research Center Bristol-Myers Squibb Warehouse Expansion $2 M 1996 CHUL Biomedical Research Center $22.3 M 1996 MDS Nordion Radiopharmaceutical Wing - HVAC $1 M 1996 System Upgrade Merck Frosst Prilosec Project $8 M 1996 Merck Frosst Clinical Packaging Area $5 M 1996 Pfizer Renovation of Aseptic Suite $5 M 1996 Pfizer CIP/SIP Process Automation $1 M 1996 Pfizer Dry Blending Unit $1 M 1996
  20. 20. Total Cost Year ProMetic Pharma Sterile Production $0.5 M 1996 Wyeth-Ayerst Renovation of Analytical Chemistry $2 M 1996 Laboratory Biotechnology Research FDA and HPB Compliance $3 M 1995 Institute Bristol-Myers Squibb Renovation of Laboratories $10 M 1995 Confab-Biopharm, Algeria FDA Compliance $10 M 1995 Enfant-Jesus Hospital Neurobiology Research Center $10 M 1995 Glaxo New Research Facility, Laboratory, $40 M 1995 P&D, Pilot Plant Merck Frosst Preparatory Laboratory $4 M 1995 Pharmascience Pilot Plant Renovation $0.5 M 1995 Royal Victoria Hospital New Animal Quarters (vivarium) $3.1 M 1995 UCB Farchim, Switzerland Active Substance Production ∈6 M 1995 Facility for Pharmaceutical Product Pfizer, France Research Center Extension N/A 1993 Upjohn Pfizer Valdepharm, Pharmaceutical chemical unit ∈32 M 1992 France Finorga, France Revamping of a chemical ∈20 M 1992 pharmaceutical facility Janssen Pharmaceutica, Pharmaceutical unit (pill coating) ∈6 M 1990 France Pfizer, France Organic synthesis facility ∈15 M 1989
  21. 21. 4. PERTINENT EXPERIENCE – VALIDATION Client Project Year Abbott Provided assistance to the validation department 2002-2003 Montréal, Quebec for various projects: • Preparation and execution of protocols for the facilities • Qualification of utilities for equipment, including medical gas • Equipment qualification, including tray packers • Pre-project engineering studies • Review existing validation protocols and follow-up of Change Control program. Andlauer Transportation Validation and Qualification of the Laval 2006-2007 Services (ATS) Inc. Warehouse. Scope of qualification included Montréal, Quebec empty and loaded temperature mapping of warehouse. cGMP Design Review and System Qualification 2004-2005 for designated GMP Distribution Warehouse. Andlauer Transportation Development of the Corporate Validation 2004 Services (ATS) Inc. Master Plan for GMP and related temperature Toronto, Ontario controlled distribution services. Additional compliance services also included: • cGMP training and Good Documentation Practices training • cGMP review of internal distribution and handling processes • cGMP review of local SOP’s AstraZeneca Canada Inc. Ventilator Autoclave System Qualification 2001 Mississauga, Ontario Validation of the Blow/Fill/Seal Production 1999 Department expansion, including preparation of the Validation Project Plan; preparation and execution of protocols for the BFS Filling Equipment and Finishing Line, On-Line Leak Detectors, Blister Pack Equipment, Autoclaves, Facility, Facility Monitoring System; HVAC,WFI, Medical Gas and Pure Steam Modifications
  22. 22. Client Project Year Validation of the Expansion of the Liquid Preparation area, including preparation of the Validation Project Plan; preparation and execution of validation protocols for the Facility, New Tanks, Automation and CIP systems; HVAC, WFI, Medical Gas and Pure Steam Modifications; preparation of SOPs for the CIP system and New Tanks. Protocol preparation and execution. System 2004 Qualification(s) of 53’ temperature controlled transportation trailers including IQ/OQ/PQ with focus on monitoring and control system controls, empty chamber and loaded chamber temperature mapping studies.
  23. 23. Client Project Year Aventis Pasteur Ltd. B93 - Qualification of the Formulation, Filling Ongoing Toronto, Ontario and Freeze Drying Equipment. IQ/OQ/PQ (Ongoing Long Term Validation activities, Cycle Development & Partnership since 1997) SOP Preparation for: • Freeze Dryer • Filler/Capper/Stopper Machine • Isolators Site Part 11 Remediation of Excel spreadsheets and/or other analytical software for the integration to a New Data Repository System - for fifteen (15) systems: • Creation of User Access Forms for creating new User Access Groups, addition of existing users to these User Access Groups and the modification of network folder file permissions. • Create specification documents for those systems. Including affected areas such as Data Storage and Retrieval, Security Design, and Archive Capabilities. Site R&D – Part 11 Remediation Services: • Collect information on the use of various systems for preparation of User and Functional Requirement Specifications. • Prepare and execute the Qualification Protocols and prepare final reports. • Provide user training on the updated SOPs on changes made through remediation of the system. B53 Suite 2 Facility Monitoring System – PQ Validation activities Various Buildings (AvP Site) – 8 WFI Control 2003 Panel utility upgrades – IQ/OQ validation services. B93 HVAC Cross Contamination Study – Multi Product Facility requiring dedicated segregation between facilities.
  24. 24. Client Project Year HVAC PQ / Environmental Monitoring 2002 Qualification. Autoclave Revalidation IQ, OQ, PQ & Cycle Development. Qualification of On line TOC Analyzers. Compressed Air – On Line Air Drier Qualification. Medical Gases – Nitrogen, Oxygen and Compressed Air – including P&ID Development, FRS Preparation, IQ, OQ, and PQ. Qualification of RSV Purification and 2001 Formulation process equipment, including a 20L, 200L, three 2000L Bioreactors, Harvester, Media Tanks, Centrifuge, two CIP Skids, 2 HVAC Systems, and Building and Process Computer Monitoring Systems. Qualification of several HVAC Systems, including Environmental Monitoring. New Research & Development Facility - 2000 preparation of the Validation Master Plan; preparation and execution of the Validation protocols and preparation of the applicable PM and Operational SOPs for various systems and equipment. Preparation of the PM and Operational SOPs for various systems and equipment for the Component Pertussis Manufacturing Facility. Preparation of SOPs for the Maintenance Department for specific maintenance policies and the PM SOPs for various systems and equipment. Validation of the Facility Monitoring System for the BCG and Hepatitis-A Manufacturing Facility. Validation of the Facility Monitoring System for the Polio Manufacturing Facility. Research & Development Building – Validation 1999 of the Lyophilizer, HVAC system, Fermenter
  25. 25. Client Project Year and Filler. Bacterials – HVAC Qualification. Primary Production Measles – HVAC/ Duct 1999 Blowers Qualification. Sterility Test – HVAC Validation. Cleaning Validation for various departments, 1998 data analysis and preparation of final reports. Validation of the Filling and Packaging 1997 Department, including preparation of applicable SOPs and Process Development for the Autoclaves. Validation of the Material Distribution Centre, including the preparation of applicable SOPs. Validation of the WFI System for the Operations Building, including the preparation of applicable SOPs and the Validation Master Plan Addendum. Aventis Pasteur Validation and Non-Strategic Project Support Ongoing Swiftwater, PA, • Scope of services include providing an (USA) integrated on site Validation Group (6- 10 personnel including a Site Project Manager) capable of executing on- going validation projects for a 1 – 2 year period. The SLP team is multi- disciplinary and specialized in various equipment / systems and services specific to this site. FAT and SAT Commissioning coordination and 2002-2004 execution review and witness for 2 new Large Scale Production Autoclaves. Preparation and Execution of IQ, OQ, PQ protocols , as well as Worst Case Assessment, Cycle Development, and equivalency studies for over 500 Load Items categorized within 5 Load Types. Preparation and Execution of IQ, OQ, PQ protocols , as well as Worst Case Assessment and Cycle Development for 2 existing large scale production Autoclaves, and 1 large scale
  26. 26. Client Project Year production Depyrogenation Ovens. Various validation projects including system troubleshooting, various Process Validation assistance, Report Writing and Data Analysis and AvP Site Validation Guideline Development. Banner Pharmacaps GMP and QC training 2004 Olds, Alberta Validation of the Production and Containment 1998 to 2000 Facility, HVAC, BAS, Vacuum, Steam, Drying rooms, BMS and Water systems Bayer Diagnostics Development of OQ protocols for functional 2003 Mishawaka, Indiana, USA testing of packaging equipment using PLC ladder logic to force permissive bit for path analysis and machine interaction verification. Programming platforms used were RSLogix 500, RSView 32, MachineShop, and 505 Workshop Bio-Intermediair Inc. Clean Utilities Validation for a new Bio- 1996 Montréal, Quebec pharmaceutical Research & Development Facility – Purified Water, WFI and Clean Steam systems Process and Cleaning Validation Design of processes for the production of antibodies using fermentation and purification processes for components or products resulting from bacterial fermentation Biomatrix Process and Utility Validation of the entire plant 1998 Montréal, Quebec Bristol-Myers Squibb Conformity audit of systems linked with to 2006 Medical Imaging engineering group to propose ventilation and Dorval, Quebec, (Quebec) laboratory environment improvements Mississauga, Hamilton, Validation of clean room ventilation systems (Ontario), Vancouver (BC) Bristol-Myers Squibb Various projects including: 2002-2007 Candiac, Quebec Validation of process equipment Validation of HVAC, clean steam, nitrogen systems
  27. 27. Client Project Year Change control, SOP writing Engineering and maintenance department support Various projects including: 2001-2003 Construction and validation of the Clinical Supplies Operation Building, anti-tumor facility Validation of lyophilizer, dry heat oven and autoclaves Qualification for modifications of clean rooms and pure steam system Construction and validation of the Clinical Supplies Operation Building, Packaging and 2002 labeling facility Validation of the compressed air system, vacuum system, dust collector system, HVAC systems, nitrogen system, and Building Automation System Construction and validation of the Clinical 1999 Supplies Operation Building, manufacturing facility Validation of a new clean compressed air system and a new house vacuum system Brunet-Graillon Pharmacy Validation of clean rooms 2006 Gatineau, Quebec Validation of ventilation systems Writing laboratory procedures for operation and Quality Assurance Canadian Blood Services Validation Projects for various systems and Ongoing Various locations equipment including: Long Term throughout Canada Partnership Development of Corporate VMP. since 2000 Development of specific Site VPP. Development of standard protocol templates for Ultra Low Freezers, Freezers, Refrigerators, Incubators, Dry Block Heaters, COBE Spectra Apheresis Unit for global site use. Development of URS and FRS for COBE Spectra Apheresis Unit.
  28. 28. Client Project Year Development of URS templates for Freezers, Refrigerators, Incubators, Agitators, Centrifuges, Plate Readers, Cryobaths, Biohazzard Hoods, Fume Hoods, Dead Air Boxes, Sonicators, Water Baths, Plate Washers, Bag Sealers, Gamma Cell, Haemonetics PC S2, Olympus PK 7100/7200, Cell Processor. Facility Commissioning / Qualification including HVAC, Fire Suppression, Back-Up Electrical and Site Security System. Qualification of Ultra Low Freezers, Freezers, Refrigerators, Incubators, Centrifuges and Cell Washers. Cangene Corporation Expansion of a Biotechnology Manufacturing 2004 Winnipeg, Manitoba Facility Site. Preparation and execution of Validation Protocols for various systems and equipment, including: • cGMP Sterilization Autoclave • Decontamination Autoclave • Bioreactors • Biosafety Cabinets and Laminar Flow Hoods • Centrifuges • Clean Steam System • Compressed Air Delivery System • CO2 Delivery System • Nitrogen Delivery System • Oxygen Delivery System • Switch-Over Manifold for Medical Gases • Coolers • Drying Oven • HVAC Systems • Filter Integrity Tester • Controlled Rate Freezers • CO2 Incubators • Chilled Water Recirculators • Hydrogen Peroxide Vapour Generator • Isolator • Vacuum Jacket Liquid Nitrogen Network • Liquid Nitrogen Storage Tanks • Vacuum Pump and Network
  29. 29. Client Project Year • Water Baths • Purified Water System New Biotechnology Manufacturing Facility. 2002 Preparation of protocols and supervision of Cangene team during protocol execution of process equipment, including: • Bioreactors • Centrifuges • cGMP Sterilization Autoclave • Decontamination Autoclave • WFI, Pure Steam • Biosafety Cabinets, Fume Hoods, and Laminar Flow Hoods • Media preparation • SCADA • HVAC and BMS New Biotechnology Manufacturing Facility Site 2001 Validation. Preparation and execution of Validation Protocols for various systems and equipment, including utilities, reactors, CIP Skids, Delta V Automated Monitoring & Control System Centocor, Inc. Development of Technology Transfer Master 2002 Malvern, PA, USA Plan CIBA Vision Analysis and revision of all IT SOPs 2004 Mississauga, Ontario Validation of the Laboratory Management System Ongoing Site Validation Master Plan, Equipment since 2003 Validation Master Plan, Process Validation Master Plan, and Computer Systems Validation Master Plan document preparation and approach development. IQ/OQ/PQ Equipment, Process and Cleaning Validation Activities for various equipment including HVAC, Purified Water Systems, Purified Steam System, Medical Gases, Tanks, Pumps, Autoclaves, Filling and Packaging Equipment. Bulk Product Sterilization - Cycle Development and Worst Case assessment for approximately
  30. 30. Client Project Year 30-40 product types. Confab Audit of an ERP JDEdwards system Ongoing St-Hubert, Quebec Training and support for an FDA inspection Contract Pharmaceuticals Equipment Qualification –preparation and 1999 Mississauga, Ontario execution of IQ/OQ protocols for the Manufacturing tanks, Homogenizers, Pumps, Mixers, Liquid Fillers, Bottle Unscramblers and Plastic Tube Fillers CV Technologies Quality assurance system assessment of the Ongoing Edmonton, Alberta potential vendor/supplier Dermolab Validation of 3 ventilation systems, 2004 Ste-Julie, Quebec thermopump and compressed air system (IQ/OQ/PQ) Draximage Process Validation 1999 Montréal, Quebec Draxis Pharma Inc. Development of a terminal steam sterilization 2005 Montréal, Quebec cycle Validation of the production autoclave control system following program upgrade Validation projects for various systems and 2003-2004 equipment including: • Qualification of a large-scale lyophilizer (including CIP/SIP capabilities) and automatic vials Loading/Unloading system • Autoclaves (2 units) and drying ovens (2 units). • Autoclave cycle development • HVACs, Laminar flow Hoods and dispensing booths. • SOP writing/training for many different systems and equipment. • Validation of Computerized systems. • Qualification of packaging equipment. • Qualification of a Pure Steam system and nitrogen system. • Qualification of container washing machines, filling / stoppering / capping machines, and manufacturing
  31. 31. Client Project Year equipment. DSM Biologics Compliance Upgrade Project to modify existing 2004 Montréal, Quebec Quality Systems for an existing Biotechnology facility. Services includes Training Program and SOPs Program. Validated equipment and systems: • Bioreactors • Media Prep. • Computer validation • SCADA and BMS • Maximo. Personnel loan for QE department of replacement of their QA Manager and involvement on QC tasks. Large Scale Expansion Project for a new facility 2003-2004 for contract manufacturing of BL-1 monoclonal antibodies and recombinant proteins by cell culture. The facility will be mainly used for the production of Phase III and commercial drug active ingredients. Validation services included the following: • Preparation and coordination of the User Requirement Specifications • Preparation and completion of the Enhanced Design Review Process • Review and coordination of Functional Specifications • Preparation and completion of a FAT and SAT template These services were provided for the following systems: Upstream Process Equipment: Seed Bioreactor & PLC 30 L, Seed Bioreactor & PLC 150 L Seed Bioreactor & PLC 750 L Seed Bioreactor & PLC 3000 L Production Bioreactors & PLCs 12 500 L Feed Tank 2500 L Feed Media Addition Tank 4000 L Bioreactors CIP & PLC Process Tanks
  32. 32. Client Project Year Process Tank PLC’s 4 Media Preparation Tanks & PLC Centrifuge & PLC Ultrafiltration & PLC Detergent holding / Distribution CIP Skids & PLC’s Process Transfer Piping Downstream Process Equipment: DSP Pre-Virus Chromatography Skid & PLC DSP Pre-Virus Chromatography Column Pre-Virus Packing Station & PLC DSP Post-Virus Chromatography Skids & PLC DSP Post-Virus Chromatography Column DSP Post-virus Packing Station & PLC DSP Post-virus TFF Ultrafiltration Dead-end Filtration Buffer Preparation Tanks & PLC & Small Buffer Preparation and Acid-Base Tanks Buffer Holding Tanks &PLC Caustic (NaOH) Tank & PLC Facility Utilities: HVAC Systems Emergency Power Building Automation Systems Walk-in Refrigerator/Freezer Clean Utilities: Pure Steam Generator Clean Air Compressors WFI System Decontamination & Neutralization & Process Drainage System & CIP Medical Gases (O2, N2, CO2) Supporting Equipment: GMP Autoclave Decontamination Autoclave Double Door Washer Laminar Air Flow Hoods Bio- Safety Cabinets Incubators
  33. 33. Client Project Year Liquid Nitrogen Cell Bank Freezers Fast Freezer Refrigerator / Freezer Chemical Fume Hoods Process Control System: Engineering Workstation Security and Historian Backup Server Historian and Trending Server SCADA Server – Train No. 2 Batch Management Server I/O Directory Server Network Server Room Process Control Supervisory System Process Transfers CIP Transfer Security Access Cards Several Validation Projects for various systems 2000 and equipment, including: compressed air, nitrogen, steam, BAS, purified water, WFI, softened water and equipment process skid, incubator, still Eli Lilly Computer Validation of a SCADA system 2005 Puerto Rico Eli Lilly Validation of a custom developed LIM System 2003 Indianapolis, IN, (USA) Preparation for a FDA Inspection 2001 Eli Lilly Validation of a Building Monitoring System Completed Toronto, Ontario Ethypharm Ensured full compliance with regulatory 2002 Laval, Quebec agencies, MCA & FDA for two facilities. This included: • Prepare and perform internal audits • Revise the documentation related to the QA system • Evaluate the validation status of the systems and equipment • Preparation of the Validation Master Plan for the Laval site and the site in France
  34. 34. Client Project Year Ethypharm QC revision and audit to conform to European 2003 Mumbai, India GMP Ethypharm GMP training 2003 Chateauneuf-en-thymerais, France Ethypharm New FDA Audit 2002, 2004 Grand Quevilly, France Two Compliance experts on site for18 months. 2001-2003 This included: • Perform Pre-inspection audit FDA and EU • Support internal QA and optimization of procedures E-Z-EM Regulatory affairs support 2006 Montréal, Quebec Federa/ Cardinal Health Validation leader of the new NOH Filling 2006 Brussels, Belgium Facility in Brussels including: • Water system • Ventilation systems • Processing equipments • Cleaning validation • Computer validation Production department leader Documentation training Validation of laboratory equipment: 2004 • Particle counter and software • Chromatograph • HPLC and software • Spectro UV and software • TOC and software • Automatic titrator • Mass spectrometer • Insulators • Insulator sterilizer Production files optimization and support Site Master File Validation Galderma Production Various projects including: 2005-2006 Montréal, Quebec • Cleaning Validation, Cleaning matrix • Process Validation
  35. 35. Client Project Year Various Projects including: 1999 • Validation of the Production Skids; Validation of the Temperature Control Room • Plant and Process Qualification • Preparation of SOPs Gambro Conformity and process support for a medical 2005 Montréal, Quebec device company Genpharm Inc. Various projects including: 2001 Etobicoke, Ontario Packaging Line & Manufacturing Equipment Validation for a Solid-Dosage Manufacturing facility Preparation of IQ/OQ/PQ protocol for compressed air systems Qualification of vaults and security system used in storing controlled drugs Preparation of two (2) Validation Master Plans: for Manufacturing Equipment/Systems and for Utilities Systems Autoclave Validation GlaxoSmithKline Validation of various systems, utilities and 2006-2007 Ste-Foy, Quebec equipment for a Biotechnology Manufacturing Facility to conform to BSL2+ Validation of systems and equipment for the Seed Preparation and QC laboratory to conform to BSL2+ Validation of air units to conform to BSL2+ Validation of systems, utilities and production/process equipment for production capacity increase conform to BSL2+ Project coordination of all stages from the end of construction to completion of validation on behalf of the client, for the BSL2+ upgrade and production capacity increase Cleaning Validation of process equipment, CIP 2005-2006 system
  36. 36. Client Project Year Validation of process equipments and systems Computer related system (CRS) assessment Commissioning of various utility systems Project coordination for the installation, commissioning and validation of various utility skids Preparation and execution of IQ/OQ/PQ and 2003-2004 SOPs for various systems and equipment for a Biotechnology Manufacturing Facility: • Laboratory, Manufacturing and Packaging equipment (fillers, stoppers, cappers, Inoculators, Harvester, Transfer Panels, Centrifuges, Inactivation UV systems, Autoclaves, Incubators, Refrigerators, Laminar Air flow hoods) • Qualification of several utility systems, (HVAC, Clean Compressed Air, USP Water, and Pure Steam) • Qualification of environmental monitoring program • Qualification of the Central Archiving System related to process equipment monitoring. Documentation review for the QA department GlaxoSmithKline Commissioning and Validation of Quality 2006-2007 Laval, Quebec Control equipments and HVAC systems to conform to BSL2+ Cleaning validation LV-01 (Bldg 15) (2006): Validation of HVAC and process equipment to conform to BSL2+ (2006) Cleaning Validation LV-02 (R&D Environment) (2007): Validation of HVAC in a BL-3 environment, of a purified water system Writing of a Validation Master Plan for a BL-3 environment
  37. 37. Client Project Year Validation of New Building 15; EPCMV project 2005 Building upgrade; Addition to the ventilation systems and purified water system Commissioning and Validation of process equipment and utilities Preparation and execution of Commissioning 2003-2004 protocols, IQ/OQ/PQ and SOPs for various systems and equipment for a Biotechnology Manufacturing Facility: • Laboratory, Manufacturing and Packaging equipment (fillers, stoppers, cappers, Inoculators, Harvester, Transfer Panels, Centrifuges, Inactivation UV systems, Autoclaves, Incubators, Refrigerators, Laminar Air flow hoods) • Qualification of several utility systems, (HVAC, Clean Compressed Air, USP Water, and Pure Steam) • Qualification of environmental monitoring program • Qualification of the Central Archiving System related to process equipment monitoring. Documentation review for the QA department GlaxoSmithKLine Assessment, preparation of a remediation plan 2006 - 2007 Hamilton, US and implement the remediation plan of computerized systems. Existing computerized system SOPs upgrade to meet new corporate requirements. Validation assistance for the Engineering department to complete validation activities and document and resolve pending validation deviations.
  38. 38. Client Project Year GlaxoSmithKline EPCMV of a new building 2005-2006 Biologicals (WN-128) Writing of commissioning documents and the Wavre Nord, Belgium writing and execution of validation protocols, including: • HVAC systems for laboratories (41 systems including BL-2 and BL-3), cold rooms (20 units) and incubators • Bench LAF, Pass-Boxes, Process Tanks • Utility Systems (Process compressed air, Process steam generator and distribution circuit, CEC – decontamination station, EDI – demineralised water, EPI – industrial clean water, CIP, SIP) • PEMS – Process Environmental Monitoring System • Washing machines (2 items) • Sterile autoclaves (4items) • Decontamination autoclaves (8 items) GlaxoSmithKLine Validation of process services, clean building 2004 Biologicals (WN-119) utilities, vaccine production Belgium GlaxoWellcome Design Qualification Summary and Review of 1998 Mississauga, Ontario the USP Water System for the Mepron & Malarone Manufacturing Suite Héma-Québec Preparation of a validation master plan 2003 Montréal, Quebec Hemosol Inc. Validation services for a new commercial 2000-2003 Mississauga, Ontario facility to manufacture a blood product extracted from expired human blood. Services include the preparation of the VMP; preparation and execution of DQ/IQ/OQ/PQ protocols for: • Customized process equipment skids • SCADA • Customized software systems • Network infrastructure • Utilities including several HVAC systems, Compressed Air system, Medical Gases (Nitrogen & Oxygen) Systems, WFI, Clean Steam System, Purified Water System
  39. 39. Client Project Year • Building Automation System • Autoclaves Hemosol Inc. Review of existing critical utility systems and 2001 Toronto, Ontario the applicable documents in preparation for a Pre-approval Inspection. Validation services for the Scale-up Plant, including the preparation and execution of IQ/OQ/PQ protocols, preparation of SOPs and Process & Cleaning validation for the associated systems, equipment and processes. Homeodel Conformity Audit Ongoing Montréal, Quebec Regulatory affairs support Training on GMP for natural and health products Intelligene Expressions Inc. New Fermentation Plant 1998 Edmonton, Alberta Johnson & Johnson Medical Walk-in Cooler Validation – preparation and 2000 Products execution of IQ/OQ protocol, including empty Markham, Ontario chamber and loaded chamber temperature mapping, data analysis and final report Preparation of the required documents for the 1999 Qualification of the Distribution Warehouse Temperature Control JSS Medical Research Conformity Audit 2006 Montréal, Quebec Training on the validation lifecycle: development of URS, FS, DS, Programming Standards, IQ, OQ, execution of IQ and OQ. Providing support to achieve compliance to 2004 their site’s quality assurance system with applicable regulations. Project scope of services includes: • Giving training sessions to update JSS personnel on computer validation and 21 CFR 11 basic requirement, Good Clinical Practices, and Good Documentation Practices. • Writing of a Quality Master Plan
  40. 40. Client Project Year • Support for computer system and computer validation • Support for Quality Assurance Knowlton Packaging Conformity Audit in microbiology Ongoing Knowlton, Quebec Computer Validation Master Plan and Assessment of an ERP system Labopharm Validation of pilot production equipment in the 2006 Laval, Quebec laboratories for: • Press Stokes 560 (#PRE-04) • Metal detector device in tablets • De-duster Validation of pilot production equipment in the 2004 laboratories for: • Korsch Tablet Press • Korsch Compression Research System – Computer Interface • Glatt Fluid Bed Dryer • Vector Laboratory Development Coating System • Pk Blend Master V-Blender • Single Stroke Stokes F4 Tablet Press – Powder Compacting Press • Quadro Comil • Glatt High Shear Mixer • Manesty Drycota 23 Station • Cap Seal Jr. Induction Heating Generator LBVA-Veterinary and Food New Biotechnology Manufacturing Facility 2003-2007 Biotechnology Laboratory, Site. Faculty of Veterinary Preparation of a compliance report and Medicine, Université de presentation to the applicable regulatory Montréal agencies of Canada and USA. St-Hyacinthe, Quebec Preparation of various Standard Operation Procedures for systems, equipment and programs Preparation of the Site Validation Master Plan, preparation and execution of Validation
  41. 41. Client Project Year Protocols for various systems and equipment, including: • Building Automation System (BAS) • Classified clean rooms • HVAC Systems • USP Purified water • Pure steam • Water For Injection • Clean compressed air • Medical gases: CO2 • Medical gases: N2 • Medical gases: O2 • Biological safety cabinets • CO2 and standard Incubators • Fermenters • Refrigerators • Freezers • Pumps • Sterilizing autoclave • Glassware washer • Freeze dryer • Process tanks • Transfer pump • 4°C room/quarantine Les Laboratoires Aeterna Validation of the HVAC system and utilities in 1999 Sainte-Foy, Quebec the Manufacturing Plant Les Laboratoires Riva inc. EPCMV (Engineering, Procurement, 2005 Blainville, Quebec Construction Management, Validation) of a new USP purified water system – IQ/OQ, PQ Malinckrodt Validation of Process Equipment 1997 (USA) Margo Inc. Validation of filling and packaging equipment 2002 Division of the Alcan Group including protocol preparation and execution: Jamesburg, NJ & • Tube Fillers Bethlehem, Pennsylvania • Autoclave, including Operation & Maintenance SOP Validation services for a new contract packaging facility including preparation of: • Validation /Cleaning Master Plan • Facility validation protocols IQ/OQ/PQ
  42. 42. Client Project Year for: HVAC, CA, BAS, Vacuum • SOPs for HVAC, CA, BAS, Change Control • SOPs for the Validation approach, Computer system periodic review, Security of computer system and back- up and recovery Martec Pharmaceutical Validation of a New Solid Dosage Production 1996 USA Facility, including the preparation of the Validation Master Plan; the Presentation of the VMP to the FDA authorities; preparation of the applicable Operation, Maintenance, Cleaning and Calibration SOPs; and validation of various Pilot Plant equipment Martec Scientific Process Equipment Validation 1997 (USA) McNeil Consumer Products Consumer Products Facility - Validation of the 1997 Guelph, Ontario HVAC and Building Automation systems and Incubator Mappings MDS Nordion Inc. Preparation of the KRMF Phase 2 VMP, VPPs 2003 Kanata, Ontario (Facility, Component Preparatory Room and (Long Term Partnership Paragon Manufacturing) and Facility from 1997-2003) Commissioning Master Plan. Qualification of the Component Prep WFI system, DI system, Particle Monitoring System, Autoclave, VHP unit, Vial Washer, Glassware Washer, Stopper Processor and Bag Sealer. Facility Qualification including HVAC, BAS, Architecture, Clean rooms and medical gases. Project Management for the Validation and Compliance activities required to achieve FDA approval for a Radiopharmaceutical Cancer Therapy. Preparation and delivery of a Training Session 2002 on the GAMP 4, including CFR 21 Part 11 Compliance Update. Preparation of protocols and SOP for the qualification of a Vaporized Hydrogen Peroxide insert.
  43. 43. Client Project Year Documentation Review of Processes and 2000 Equipment for GMP and adherence to Validation Guidelines, for mechanical systems, production and QC testing equipment used in the manufacturing and testing of radio- pharmaceutical products. Project Management for the validation and compliance activities required to achieve FDA approval for a Radiopharmaceutical Cancer Therapy. Validation of the Manufacturing Operation of isotopes for Radiopharmaceutical applications – preparation of protocols and the review of documents for various systems and equipment. MDS Pharma Services Validation of a Clinical Trial Database System 2006 Mississauga, Ontario Various Computer Validation projects, which 2003 include: • Compliance Audit for Clinical Trial Database System • Preparation of report detailing remediation activities for the database system • Preparation of Test Plans for customized interfaces • Preparation and execution of Test Scripts for customized interfaces MDS Pharma Services Development of a management system for the 2006 St-Laurent, Quebec revision of 5 years of clinical studies results and information Computer Validation (PQ software system) Medicago Training on validation 2006 Ste-Foy, Quebec Conformity Audit Validation and commissioning of HVAC system Merck Frosst Canada Validation of laboratory equipment: Karl Fisher 2002 Montréal, Quebec Titrator Compressed Air Renovation Qualification 2000 Various Projects, including: 1999 • Qualification of the Quality Operation
  44. 44. Client Project Year (QO) Building • QO Building - Autoclave and Incubator Qualification • Training Documentation for the QO Facility • Track 3 – Qualification of the USP Water System • Mogensen Sizer Qualification; Kady Mill Qualification Building 2 – Building Automation System 1998 Process Equipment Qualification QO Building – BAS Qualification Preparation of the Standard Validation Format for the BAS system Cold Room Distribution Centre Lot 3 1997 BAS Qualification – Phases I and II Lot 4 – Vacuum and Drainage Systems Validation of the Clinical Supplies Packaging 1996 Building, including the preparation of the Validation Master Plan and preparation of applicable SOPs Pilot Plant, Clinical Production 1993 Merck Sharp & Dome Packaging Plant Validation 2000 (South Africa) Methapharm Validation services for the qualification of the 2003 Brantford, Ontario new Glovebox and the Powder Filling System Novartis Pharmaceuticals Preparation of SOPs for large scale production 1998 (USA) equipment and Process Automation system Compression/Encapsulation Department – 1997 Statistical Process Control project Novex Pharma Validation projects for various systems and 2003 Richmond Hill, Ontario equipment, including: • VHP Generator • HVAC system Non-sterile Filling Line – Commissioning and IQ/OQ/PQ for monoblock filler, capper, crimper, labeler, checkweigher, cartoner and