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COMMISSIONING, QUALIFICATION,
VALIDATION (CQV)
PARTNERING WITH CLIENTS TO PROVIDE GLOBAL INTEGRATED SOLUTIONS
www.jacobs.comOffices Worldwide
INTEGRATED SOLUT IONS
As the largest provider of professional services in the biopharmaceutical industry, clients benefit from both our local presence and global reach. Jacobs offers a range of services from advanced planning and programming to design, construction and commissioning to startup, qualification and validation. This allows us to help our clients throughout the life cycle of a project.
Our team takes advantage of a unified approach that uses dedicated CQV resources and engages automation, process and construction engineers to provide clients with comprehensive end-to-end project solutions.
By implementing an integrated project delivery strategy, based on collaboration between design, construction and CQV, we are able to deliver best-in-class facilities as efficiently as possible. We identify and resolve issues early to avoid expensive rework and use standard processes to improve our effectiveness.
The result - we design, build, commission, qualify, and validate facilities right the first time bringing clients’ products to market more quickly; this results in patients receiving the medicines they need and a faster return on your investment.
PROJECT EXAMPLES
Commissioning, Qualification, Validation (CQV)
Multiple Projects Services: CQV
We partnered with a major pharmaceutical client across the globe to provide CQV services. Projects include:
� Cleaning validation, Malaysia � Critical component assessment, United Kingdom
� cGMP & impact assessment, China
� cGMP Review and GAP Analysis, South Africa
� Facility risk assessment, Philippines
� Full lifecycle C&Q services, Ireland & UK
APS Pressurization and cGMP Upgrades Services: CQV
We provided full verification services including project management, protocol development & execution, and change management support for an aseptic facility upgrade project. Project scope included modifications to the facility, depyrogenation tunnel, and clean utilities, as well as new Grade B & D air handling units. All work was required to be completed during an eight-week shutdown.
mAb Fill/Pack Services: EP+CQV
We are providing all CQV services for a greenfield biologics manufacturing facility in Northern Europe designed to provide production capability for a range of large-molecule, protein therapeutic products. Project scope includes URs, DQ, FAT, SAT, Startup, Commissioning, IQ, and OQ for syringe & vial filling, formulation, inspection, labeling, and packaging processes.
Vaccine Bulk Facility Services: EPCM+CQV
We provided EPCM+CQV services, achieving an unprecedented 24-month schedule from charter to operational qualification for this $315 million, 214,000-square-foot, vaccine manufacturing facility. One third of craft hours were moved off site which allowed modular construction to take place while the facility layout was still being developed (interstitial, AHU, duct risers, clean room panels). Using this hybrid approach, we completed the project 40 percent faster than industry benchmarks.
AREAS OF SPEC IALTY
Our experience, expertise, and commitment provides superior services to meet your validation and compliance needs.
WHY JACOBS?
� We employ self-motivated, high-caliber CQV resources.
� We are the largest provider of integrated engineering, procurement, construction management and validation services and understand the importance of front-end loading CQV activities.
� We use design, automation and construction resources to support and optimize commissioning and qualification.
� We are an established Life Sciences market leader that has experience with emerging technologies such as gene therapy, cell therapy, nanotechnology and single use manufacturing.
� We leverage our large network of available SMEs to deliver value to our clients.
� We get client’s products to market faster with right-sized, scalable project delivery strategies.
� We partner with clients to focus on people, performance, safety and integrity - our core values and the foundation of our Company.
� We minimize costs by using local resources in strategic locations around the world.
� We can accommodate any science and risk-based life cycle approach whether it is ASTM E2500, BG5 or GAMP 5.
� We use standard processes and data management tools to provide compliant and predictable turnkey solutions that streamline project delivery.
CORE CQV SERVICES SUPPORT SERVICES CONSULTING SERVICES
� CQV Master Planning
� Requirements Development
� Risk Assessments
� Design Review and Qualification
� Factory & Site Acceptance Testing
� Startup & Commissioning
� Qualification
� Cleaning & Sterilization Validation
� Process Validation
� SOP Development
� Personnel Training
� Maintenance & Reliability
� CAPA & Change Management
� Environmental Monitoring
� Temperature Mapping
� Calibrations and Loop Checks
� Serialization
� Computer System Validation
� Site Master Planning
� Project Management
� Compliance Gap Analysis
� Quality System Auditing
� Mock Inspections
� Design Consultation
� Product Life Cycle Management
� Aseptic Processing
� Tech Transfer
Proven Leadership
Our team brings in-depth knowledge and expertise in CQV and related services. With proficient leaders around the globe, we understand international and local regulations and are able to use our knowledge and experience to deliver:
� Cost-effective, compliant solutions
� Products to market faster
� Reliable facilities that support sustainable operations and
process improvements
FOR FURTHER INFORMATION CONTACT:DAVID TYRRELLPhone: +353 (0)1 2027787 [email protected]
DR. ARCHA VERMANIPhone: +91 124 3372527 [email protected]
STEFANO GENESIOPhone: +39 335 [email protected]
SCOTT HAMMPhone: [email protected]
SCOTT HAMMDirector of CQV and Compliance Services, US
DAVID TYRRELLDir. of CQV and Compliance Services, Ireland, UK & Scandinavia
DR. ARCHA VERMANIManager of CQV and Compliance Services, India
STEFANO GENESIODirector of CQV and Compliance Services, Mainland Europe
Mr. Scott Hamm has nearly 30 years of engineering and project management experience in a regulated environment. He has a diverse CQV background and experience developing quality system documentation and processes for pharmaceutical, biotech and medical device manufacturers.
Mr. Hamm has served as a member of the ISPE Steering Team for the C&Q Community of Practice and has been involved in the review and development of ISPE guidance documents based on the E2500 science and risk-based standard.
Mr. David Tyrrell has more than 25 years of engineering and project management experience across many industries. He has a proven track record building teams and delivering projects. Mr. Tyrrell has a broad range of CQV experience and has managed CQV teams through the entire project life cycle; from conception to sustaining manufacturing operations.
With over 20 years’ client side experience Mr. Tyrrell has a clear understanding of customer needs and strives to partner with clients as a solution provider.
Dr. Archa Vermani has more than 15 years of experience designing and qualifying facilities in accordance with cGMP requirements. She is responsible for CQV and Regulatory compliance for India projects and she plays a key role in upfront project planning.
Dr. Vermani has successfully delivered many National and International CQV projects from conceptual design through validation. She has experience with Sterile, OSD, API, Biotech / Vaccines, Blood Plasma Fractionation and FMC manufacturing processes.
Mr. Stefano Genesio has nearly 15 years of experience in automation engineering and CQV project management. He has extensive experience with Regulatory Compliance and CQV activities for the full project life cycle within the Life Sciences Industry.
Utilizing his technical knowledge and management skills, Mr. Genesio can quickly identify clients’ needs and key project milestones, in order to successfully implement right – sized project delivery strategies.
