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Qualification of Staff:
Performance Validation's technical staff
is grouped into 4 technical levels based on years of
experience and demonstrated technical proficiency. These range from
our entry level position (0-2 years experience), to our
Principal level (>10 years experience). PV has the
ability to assign the correct resources to the task
based on tenure and technical expertise.
Professional Qualification Statements, which
detail individual experience for our team members are
available for customer review.
PV services include:
Commissioning & Qualification (C&Q)
Performance Validation has successfully delivered
numerous major facilities with an approximate value
exceeding 540M USD. We have experience in the
development and execution of C&Q using the ISPE Baseline
Guide(s), ASTM E2500 as well as developing C&Q programs
tailored to conform with client policies, procedures and
templates.
Services offered:
Performance Validation provides expertise with the following
Commissioning and Qualification activities:
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Consultation including recommendations on client approach, best
practices, benchmarking, audit and assessment of
current practices
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Turnkey Project Management and staffing of the entire C&Q effort
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Master plan (verification, commissioning, validation, project plan)
development & implementation
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Risk Management
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Per the ISPE Baseline Guide for system and component classification
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Per ICH Q9 for the use of standard quality tools to facilitate risk
based on scientific knowledge and protection of
the patient
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Per GAMP5 for the application of risk to automated or quality
systems
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Development, training and implementation of Good Engineering
Practices to support the commissioning effort
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Requirements & Specifications development
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Design/enhanced design review
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Vendor Management including audit, assessment, and testing
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Change management/ configuration management prior to system
turnover and acceptance
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Testing (Commissioning and Qualification,
Verification, Validation, or other testing
activities (FAT/SAT))
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Formal release/turnover activities and System Acceptance
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Periodic Review (e.g., annual audit) of the qualified systems
Experience:
Performance Validation has over 20
years of experience in performing C&Q projects for the
following types of equipment and facilities.
Equipment & Equipment Automation
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Autoclaves
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Barrier Isolators w/sterility testing (VHP,ETO)
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Depyrogenation Ovens
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Fermentors
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Filling Equipment and Lines (complete filling
lines/or individual components)
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Fluid Bed Dryers
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Glassware and Stopper Washers
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Lyophilizers
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Mills and Granulators
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Packaging Equipment and Lines (complete
packaging lines/ or individual components)
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Pasteurizers
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Transfer Systems
Facilities
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Administrative Facilities
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Animal Heath Facilities
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Aseptic Facilities
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Bulk API Facilities
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Cell Culture Facilities
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Clinical Facilities
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DEA Vaults
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In Vitro Diagnostic Facilities
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Pilot Plant Facilities
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Quality Control Laboratories
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R&D Laboratories
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Solid Dose (Dry Products) Facilities
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Temperature controlled warehouses and
production areas
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Walk in Freezers/ Cold Rooms
Utilities
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Clean out of Place/ Clean in Place Systems
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Clean Steam
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Critical Air and Gases
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HVAC systems
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Non Critical Utilities
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Water For Injection Systems
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Computer Systems Validation
Performance Validation has successfully guided numerous clients
though the current industry requirements for computer
systems validation. We have utilized our trained
professional teams to ensure that our clients' computer
systems are thoroughly assessed and documentation is
established to demonstrate that each computer system
performs to specifications, in a consistent manner, and
in compliance with federal regulations (e.g. 21 CFR Part
11, 21 CFR 820.70(i), and 21 CFR 211.68, etc.). Performance
Validation has experience in the development and
execution of CSV deliverables using the GAMP Guide(s),
and current regulatory information
as well as developing C&Q programs tailored to conform with client
policies, procedures and templates.
Services offered:
Performance Validation provides expertise with the following CSV
activities:
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Consultation, including recommendations on client approach, best
practices, benchmarking, audit and assessment of
current practices
-
Turnkey Project Management and staffing of the entire CSV effort
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Site or Global Computer System
Validation Master Plan
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Validation Master Plan including life-cycle,
security, data migration, business
continuity/disaster recovery, and decommissioning
governance
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Risk Management - utilizing the
latest GAMP methodologies tailored to access risk of
computerized sysetms
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Development, training and implementation of Good Documentation
Practices to support the validation effort
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Facilitate and document User Requirements & Functional/Design
Specifications
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Software Vendor Management including audits and assessments
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Developing and implementing
Change Management for the project/system
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Test Protocol development and execution including facilitating
deviation resolution
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Periodic Review (e.g., annual audit) of the
qualified system
Experience:
Performance Validation has over 20
years of experience in performing CSV for the following
types of systems.
Automation and Controls
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Building Management Systems (BMS)
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Environmental Monitoring Systems (EMS)
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Continuous Monitoring Systems
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Manufacturing Execution Systems (MCS/MES)
Information Management and Business
Applications
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Computerized Maintenance Management Systems
(CMMS)
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Quality Management Systems (QMS)
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Enterprise Resource Planning (ERP) Systems
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Laboratory Information Management Systems
(LIMS)
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Record Imaging Systems
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Environmental (Temperature/Humidity) Mapping
Services
offered:
Performance Validation offers the following services related to
environmental mapping:
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Consulting including characterization of equipment, permanent
monitoring probes placement, temperature control and
monitoring design recommendations, alarm strategies, MKT
calculations and analysis, and mapping study design,
development, and execution.
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Document development and summary reports for engineering studies
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Document development with respect to validation protocols,
including requirements, design review, classification,
qualification, and summary reports.
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Execution of studies, and problem resolution assistance.
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Project management and coordination of equipment, system, and
facility validation
Qualification of Staff:
All technical staff involved in performing mapping studies have
completed formal training provided by Kaye, or have
completed PV's internal training program on Kaye and Veriteq equipment.
Our internal operational procedures have been developed to ensure a
consistent approach to equipment set up, operation and
data retrieval.
Equipment
Availability:
Performance Validation maintains an inventory of calibrated and
validated mapping equipment to provide rapid response to
your needs. Our equipment includes
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100 Veriteq VL2000 data loggers
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5 complete Kaye Validator 2000 systems
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1 -
EZ Test incubator and associated Biological Indicators (for
sterility assurance)
Qualification Templates:
To provide cost reduction to our customers, Performance Validation
has developed a number of validation templates which
incorporate regulatory requirements and industry best
practices.
Current templates that are available include:
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Freezer, refrigerator, incubators
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Stability chambers
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Warehouse or production/manufacturing area
Experience:
Performance Validation has significant experience in
performing mapping studies and has completed numerous
projects for the following types of equipment and
facilities.
Equipment
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Autoclaves / Depyrogenation Tunnels/ Ovens
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Refrigerators / Freezers / Incubators
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Liquid Nitrogen Cryogenic Storage and Freezers
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Vessels / Tanks / Filters / Fermentors
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Water Baths
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Stability Chambers
Facilities
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Walk in Freezers/ Cold Rooms
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Temperature controlled warehouses and
production areas
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Environmental Baseline
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DEA Vaults
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Blood/Plasma Storage
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Medical Device Capabilities
The Quality System (QS) Regulation (21 CFR Part 820) presents the Good Manufacturing Practice (GMP) requirements for medical devices. As the FDA may audit manufacturing facilities for GMP compliance every 2 years, it is critical to ensure that all validation deliverables withstand these and internal company audits. Moreover, good validation results in more robust processes that improve production performance, minimize non-conforming product waste and ultimately save costs.
PV employs utilizes a risk-based approach to assess and solve your business needs covered by the QS Regulation and have assisted medical device manufacturers and suppliers in the following areas:
- Development and Implementation of QM Systems
- Internal quality audits and gap analyses
- SOPs development that define key processes and best practices for Process Validation, Cleaning Validation, Computer System Validation, Production Equipment Qualification, Laboratory Equipment Qualification, Test Method Validation, and Facilities and Utilities Validation
- Production and process controls
- Packaging and labeling control
- CAPA and FMEA program development
- Training Plan Development
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Construction Quality Assurance
Performance Validation has assisted pharmaceutical
manufacturers and construction companies in the
development of Construction Quality Assurance (CQA)
programs. CQA programs have been used to qualify
sub-contractors during the pre-bid process, monitor
performance through quality audit and assessments
throughout the project, and reduce downstream costs to
implement corrections through early detection of quality
deficiencies. Another benefit of early
identification and correction of quality deficiencies is
the reduction in overall validation costs in deviation
identification, tracking and resolution.
Typically steps performed for our customers include:
- Developing a quality manual and job specific
project quality plan
- Introducing employees to quality tools.
- Working with the customer to apply those tools to specific jobs to manage quality on a project to project basis.
- Develop and implement audits, checklists and
quality metric tools
- Developing standard operating procedures (SOPs) that define key processes and best practices.
- Introducing the use of risk management practices into the quality system.
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