qPCR Laboratory Project Management, Commissioning and Qualification

Project Management and CQV Support

Project Management and Qualification Services related to the build out of a new Quality Control PCR Laboratory

Project Management:

• Support of project management activities including project planning, execution of project deliverables, procurement, OEM coordination, risk management to manage unforeseen project risk and mitigate as necessary, acceptance and approval of deliverables, managing schedule, budget and team

Design Group Scope of Work:

• Development of risk-based assessments, quality plans, traceability matrices, commissioning and qualification protocols, execution of protocols, and generation of final report for laboratory instruments and equipment
• Support of qualification of new qPCR lab space and associated laboratory instruments (Nucleic Acid Extraction Systems, PCR systems, Centrifuges, Spectrometers, etc.) and equipment (Biosafety Cabinets, - 20 and - 75 Freezers)

Cell & Gene Therapy Facility CQV Support

Project Management and CQV Support

Supported Project Management, Commissioning, Qualification and Validation services supporting Cell Gene Therapy Clinical Manufacturing Facility

Project Management:

• Support of project management activities including project planning, execution of project deliverables, procurement, OEM coordination, risk management to manage unforeseen project risk and mitigate as necessary, acceptance and approval of deliverables, managing schedule, budget and team

Design Group Scope of Work:

• Generation of SDLC documentation including URS, Traceability Matrices, Cx and Qualification protocols for process equipment including sterile tube welders, magnetic separators, centrifuges, biosafety cabinets, utilities and proprietary equipment
• Additionally, compiled and executed Dynamic Performance Qualification of cleanroom spaces

Expansion of Commercial Scale Purification Suite

Project Management and CQV Support

Capital Project CQV Support for monoclonal antibody manufacturing facility purification suite

Commissioning and Qualification Services:

• Provided technical support and subject matter expertise for the commissioning and qualification of multiple pool tanks, viral skids and ultrafiltration units
• Responsibilities included engineering services to generate and execute commissioning and qualification protocols, including oversight and support of sample collection and analysis
• Provided technical expertise during CIP and SIP process cycle development
• Project was fast-tracked and included multi-shift and off-hour support

Single-Use Enzyme Replacement Therapy Manufacturing Facility CQV

Project Management and CQV Support

Capital Project CQV Support for State-of-the-Art Continuous Biomanufacturing facility employing primarily single-use technology at pilot plant scale

CQV Planning and Project Management:

• Established Validation Master Plan and Commissioning and Qualification Project Plan, employing risk and science-based methodology, in alignment with ASTM E2500
• Led CQV team with PM support, including status tracking and earned value reporting

Engineering Lifecycle Development:

• Developed User Requirements, Impact Assessments, Boundary Documents, and Design Qualifications
• Created templates and First-in-Kind documents with Quality approval at each level in order to establish an acceptable standard
• Employed grouping strategies in order to reduce number of documents generated, including 150+ systems, 400+ Lifecycle documents total

Commissioning & Qualification Services:

• Provided engineering services to qualify facility, utility, process and process-support equipment
• Generated and executed Engineering Test Plans, Installation and Operation Verifications, Installation and Operation Qualification, Performance Qualifications
• Employed risk-based assessments for systems and component to methodology
• Provided team leadership and Subject Matter Expertise for functional system groups

Computerized Laboratory System Data Integrity Assessments

Quality and Validation Engineering

Achieve/improve alignment with 21 CFR Part 11 and EU Eudralex Annex 11 requirements of compliance for site laboratory and manufacturing equipment and associated processes

Design Group Scope of Work:

• Reviewed system Standard Operating Procedures, Manufacturing Batch Records, and all Lifecycle documentation (e.g. URS, SRS, FS, CS, DS, Standard Operating Procedures, vendor supplied documents, qualification assessments, risk assessments, IOQ, Continued Qualification, TM, Summary Reports)
• Executed Data Integrity Assessments for Computerized Laboratory and Manufacturing Systems used at Regeneron IOPS Rensselaer Facilities
• Generated Data Handling and Process Flow Diagrams to map data ALCOA
• Proposed remediation for each system and process assessed to achieve 21 CFR Part 11 and EU Eudralex Annex 11 compliance
• Organized and led project meetings pertaining to the Data Integrity Assessments with automation, manufacturing, QA, and other stakeholders
  
   

Perfusion Controller Development and Product Quality Verification

Process Automation, Software Development and Validation Engineering

Performed process automation design, research and development testing, software quality testing and traceability, product quality testing and full validation of product against lifecycle documentation.

Design Group Scope of Work:

• Designed a new perfusion controller
• Deliverables included specifications (functional, hardware, software and user interface), AutoCAD drawings, programming and validation
• PLC programming used an S88 approach with control modules and equipment modules
• PLC designed to work with SCADA systems over Ethernet, Profinet or Profibus communication networks
• DeltaV landing module created for easy integration of perfusion controller into DeltaV facilities
• Portable tablet user interface created to control multiple perfusion controllers using Wonderware; Provides user security, recipe management and historized data in a 21 CFR part 11 compliant manner
• System designed following GAMP methodologies
• Robust software quality testing performed to ensure defend-ability against external audit of proprietary software
• Development and execution of full product qualification, including performance qualification, against product specific lifecycle documentation

cGMP Compliance Remediation

Evaluated business and production practices throughout for a cosmetics manufacturer to develop a joint action plan for 483 remediation to conform to cGMP. Developed documentation systems and SOPs for corporate policies; worked with contract manufacturers to ensure all GMP products were manufactured according to 21 CFR Part 211. Provided product and process development studies, improving product processes and developing new product manufacturing processes. Built complaints investigation, stability, and cleaning procedures.
 

Design Group Scope of Work:

• Product/Process Development
• Validation – Product, Process
• Line Integration/Automation
• SOP Development 
• 3rd Party Manufacturing Remediation
• Complaints Investigation
• Quality Management System Development
  
   
  
  
   

Capacity Expansion for Vaccine Production Facility

Capacity Expansion, new, ground up, full scale vaccine production facility

Project Scope
•  Building Construction
•  Production Support Clean Utilities
•  Complete Production Scale Purification Train
•  Aluminum Salts Production
•  Wash Area

Design Group Scope of Work
•  Automation for Buffer, Clean Utilities, and Wash Areas
•  GMP Batch Automation Design and Implementation
•  OEM FATs
•  Area Start Up and Qualification

Bag in Box Line and Foam/Gel Puck Line Validation

Validation and Engineering Services for Bag in Box (BIB) Line and Foam/Gel Puck Line

Validation and Engineering Services for BIB Line

• WinPak Form Fill Seal: FAT, SAT, SOP’s, OQ
• Videojet Coder: SOP, OQ
• Fox IV Labeler: SAT, SOP’s, OQ
• RA Jones Cartoner: FAT, SAT, SOP’s, OQ
• Domino Laser Printer: SOP’s, OQ

Validation and Engineering Services for Foam/Gel Puck Line

• PCM Filler: FAT, SAT, SOP’s, OQ
• PSA Torquer: FAT, SAT, SOP’s, OQ
• Accraply Labeler: FAT, SAT, SOP’s, OQ
• Domino Laser Printer: SOP’s, OQ

Commissioning, Qualification, and Relocation

Legal and business drivers resulted in the design, construction, commissioning, qualification and registration of a new manufacturing facility. 

Project Scope

• Provide quality and validation resources for the assessment, planning and management of relocation
• Compile schedules, documentation and vendor service agreements for successful inspection and release of the new facility
• Project included relocation of operations to a renovated 110,000 sq./ft. office building and a recently constructed 100,000 sq/ft warehouse and manufacturing suite
• Deliverables included Commissioning and Qualification of Purified Water, Nitrogen, Compressed Air, Cool Room, Warm Room, Controlled Storage Area, Controlled Environment, and Building Monitoring Systems
• Project was managed with a hard end-date due to commitments to Agency Audits for TGA, BSI, and FDA being scheduled with a 4-month lead time
• All documentation and qualifications were completed within the respective target dates and presented to inspectors successfully
• The cross functional team was also responsible for generating all maintenance procedures and support documentation
• Additional support was provided for Audit Readiness, Protocol Updates and Generation as well as Root Cause Analysis and Corrective Action
• This effort employed over 4000 direct labor hours of support

Utility Commissioning Services

Provide commissioning services for facility and utilities in new commercial production space.
 

• Generate user requirement specifications, commissioning documents and turn over packages (TOPs) for modified utilities (plant steam, pure steam, O2, CO2, N2, Compressed Air (CDA), WFI, chilled water, waste, HVAC and Facilities).
• Reviewed TOPs, field verified all installed utilities, resolved any variations between design and as built conditions, executed commissioning documents and modified URS’s as required.

Continuous Manufacturing

Design Group Scope of Work:

• Paperless Commissioning
• 50L SUB/ATF/VAC
• Chromatography Skids
• Wave Mixers
• SUMV
• TFF
• VI
• Tube Sealers