EAST COAST VALIDATION SERVICES, LLC is a Validation, Project Management, and Validation Maintenance Systems service company serving the Biotech and Pharmaceutical industries.
Founded in 2005, East Coast has over twenty years experience in GMP operations which enables us to provide high quality, cost effective service to industries regulated by the FDA.
Our Clients
Avecia Biologics
Billingham, UK
Projects Completed
- Reviewed equipment and critical utility system Validation documentation for Avecia Biologics (a microbial fermentation CMO) to assess readiness for their first FDA Pre Approval Inspection. Made recommendations for improving PAI readiness and provided consulting support to implement these recommendations over an eight month period. PAI was recently held; drug licensure is expected by the end of March.
- The FDA auditors involved took copies of Equipment Qualification Reports developed to prepare for the PAI as examples of current industry practice.
References
- John Kilgour (Director of Quality Assurance)
Organogenesis
Canton, Massachusetts
Projects Completed
- Developed URS and FRS documentation for automated tissue culture processing equipment.
- Qualified GMP production equipment, including a specialized tissue cutting system.
References
- Paul Strouth (Validation Engineer)
- Ted Donahue (Automation Engineer)
Genzyme
Framingham, Massachusetts
Projects Completed
- Qualified new and upgraded Validator 2000 dataloggers to software version 2.33
- Qualified (IQ and OQ) Pall Filter Integrity Testers
References
- Denise Connelly (Validation Manager)
Genzyme
Framingham, Massachusetts
Projects Completed
- Requalified Autoclave loads
- Requalified Depyrogenation Oven loads
- Qualified new Autoclave loads
References
- Joe Baumann (Senior Director of Validation)
Genzyme
Framingham, Massachusetts
Projects Completed
- Environmental Chamber Qualification (IQ and OQ)
References
- John Zurheide (Validation Manager)
Genzyme
Framingham, Massachusetts
Projects Completed
- Requalified Cold and Warm Rooms
- Requalified Temperature Controlled Warehouse
References
- John Zurheide (Validation Manager)
Lonza Biologics
Portsmouth, NH
Projects Completed
- Commissioning and Operational Qualification of a new 20K Cell Culture Train
- SIP and CIP qualification of a new 20L Cell Culture Train
- Qualified critical utility (WFI, clean compressed air, speciality gas) expansions for a new 20K Cell Culture Train
References
- Dan Milewski (Validation Project Manager)
- Karen Wiseman (Project Manager)
Advanced Cell Technology
Worcester, Massachusetts
Projects Completed
- Qualified Controlled Temperature Units (CTUs), Biosafety Cabinets and other Clinical Production equipment for a stem cell Clinical Manufacturing laboratory
- Qualified an HVAC subsystem serving a Clinical Manufacturing laboratory
References
- Linda Lemieux (Director, QA/QC)
Eisai Research Institute
Andover, Massachusetts
Projects Completed
- Qualified CTUs for a GMP Warehouse expansion
- Qualified paperless dataloggers to allow paper chart recorders to be discontinued
References
- Randy Earle (Validation Engineer)
Johnson Matthey Pharma Services
North Andover, MA and Devens, MA
Projects Completed
- Developed Validation Master Plans and Impact Assessment procedures for API production facilities and equipment.
- Developed and executed qualification protocols for critical utilities, production equipment and production rooms.
- Developed Gap Analysis documents for Process and Cleaning Validation.
References
- Steve Hjelm (Validation & Maintenance Mgr)
Shire HGT
Cambridge, MA
Projects Completed
- Assisted the Shire HGT Validation team during a 2007 facility shutdown. Developed, executed and summarized Change Control driven validation activities for manufacturing equipment such as chromatography skids, ultrafiltration skids and CIP systems.
- Based on the team’s performance, ECVS’s scope was expanded to provide additional equipment and critical utility validation support through YE2008.
References
- Eric Giguere (Validation Manager)
Medical Device Manufacturer
Name withheld for confidentiality
Projects Completed
- Developed a User Requirements Specification (URS) for a Controlled Environment suite of a new Medical Device pilot manufacturing facility. Based on this URS, developed and executed IQs, OQs and PQs for the Controlled Environment suite HVAC and Compressed Air systems.
- Developed Validation Project Plans and Change Control related IQ and OQ documents for an HVAC renovation at a second facility operated by this manufacturer.
- Based on ECVS performance, this client has requested ECVS assistance with equipment, utility and process validation assistance for a Combination Product under development.
References
- Confidential (Confidential)
Momenta Pharmaceuticals
Cambridge, MA
Projects Completed
- Qualified laboratory equipment, such as CO2 incubators, refrigerators, -20°C and -80°C freezers, LN2 (cryo) freezers, benchtop centrifuges and spectrophotometers to prepare for performing GMP Release testing in the laboratory.
References
- Michael Michelak, Ph.D. (Senior Scientist)
- Josh Sorafine, Ph.D. (QC Manager)
Molecular Insight Pharmaceuticals
Cambridge, MA
Projects Completed
- Reviewed HPLC manufacturer’s IQ and OQ/PV reports; organized reports and execution data for multiple systems.
- Developed URS and RTM documentation for Remote Access data review and run configuration functionality for multiple HPLC systems.
- Developed Risk Based Validation Policy, User Requirements Specifications, Design Qualification, Facility Risk Assessment and Validation Master Plan documents for a multiproduct development and clinical manufacturing facility. These documents incorporated elements of the ASTM E2500 standard for Risk Based approaches to Validation.
References
- Jeff Priem (QA Director)
Merrimack Pharmaceuticals
Cambridge, MA
Projects Completed
- Developed and executed a Cleaning Verification program (including MACO calculations and swab recovery studies) for equipment used to produce Clinical Materials.
References
- Kevin Murphy (Senior Scientist)
Drug compounding CMO
Confidential
Projects Completed
- Developed a Process Validation protocol for an API/polymer excipient compounding process. Assisted with PV execution, documented and resolved PV Deviations and Discrepancies; developed the PV Summary Report.
- Developed and executed Swab Recovery and Cleaning Verification studies for equipment used to compound API materials.
References
- Confidential (Confidential)
DPT Laboratories
Curacao, NA
Projects Completed
- Developed Validation Project Plans for the installation and qualification of two new autoclaves and a Clean Steam Generator. Documented the Validation Approach and Risk Assessment for Maximum Load Configurations used for PQ.
References
- Jim Lube (Project Manager)
Amerifit Corporation
Cromwell, CT
Projects Completed
- Developed, executed and summarized a product Packaging PQ for a new CMO Packaging line. Assisted the Packaging CMO with Cycle Development activities to improve system performance and meet Acceptance Criteria.
References
- Julie Bagley (Senior Manager of Regulatory Com)
Precision Pharma Services
Melville, NY
Projects Completed
- Qualified GMP Production equipment such as incubators, softwall enclosures, depyrogenation ovens and tunnels.
- Qualified Kaye Validator 2000 dataloggers; developed Operation and System Administrator SOPs for same.
- Qualified HVAC and Pharmaceutical Compressed Air system upgrades implemented during a scheduled facility shutdown.
References
- Colleen Millan (Validation Manager)
Seabrook International, LLC.
Portsmouth, NH
Projects Completed
- Conducted Validation training sessions for management and production lead operators of Seabrook International, a Medical Device CMO. Developed Process Validation plans for Medical Device component production.
References
- John Ruggieri (Director of Engineering)
Children’s Hospital of Boston
Boston, MA
Projects Completed
- Verified Installation, Operation and Performance of multiple autoclaves and glasswashers for a preclinical research facility.
- Verified Installation, Operation and Performance of a Decontamination autoclave in response to new state biowaste handling regulations.
References
- Curtis Liddle (Radiation Safety Officer)