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PV services include:
Construction QA
Quality assurance is the application of systematic methods to all areas of a business that affect quality. PV assists construction contractors in the development and implementation of a quality system.
Typically steps performed for our customers include:
- Developing a quality manual.
- 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.
- 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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Validation Master Planning
PV performs services encompassing all aspects of regulatory validation for the pharmaceutical, biotech, and medical device industries. We develop detailed Validation Master Plans and risk based assessments to determine proper validation and commissioning scope, and ensure compliance of each system or facility.
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Computer Systems Validation
PV has been performing computer systems validation since its inception. Computer system validation ensures that computer systems are thoroughly assessed and documentation is put in place to demonstrate that each system performs exactly according to specifications, in a consistent manner, and in compliance with federal regulations such as 21 CFR Part 11.
Systems include:
- Laboratory Information Management Systems (LIMS). PV has validated such solutions as PE Nelson SQL*LIMS, Beckman LabManager, LabVantage Sapphire, and Beckman Peakpro, to name a few.
- Computerized Maintenance Management Systems. PV has validated such solutions as PMC2000, MAXIMO, and Total Maintenance Software.
- Continuous Monitoring Systems. PV has validated such solutions as GE/Kaye LabWatch.
- Enterprise Resource Planning Systems. PV has validated such systems as SAP and MRPII.
- Building Management Systems
- Deviation Tracking Systems. PV has implemented, validated and trained customers on TrackWise software.
- HPLC Systems
- Record Imaging Systems
- Manufacturing Execution Systems
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Production Equipment and Laboratory Instrumentation Qualification
Equipment and instrumentation qualification are key elements in determining that the quality assurance standards of a pharmaceutical product or medical device are met. The goal is to ensure, with a high degree of confidence, that equipment used to manufacture a product and laboratory instrumentation used to test a product consistently meet pre-determined specifications, and that successive lots of the product are acceptable as per FDA guidelines.
Validation Experience includes:
- Spectrophotometers
- Total Organic Carbon Analyzers
- HPLCs and GCs
- Process Chromatography
- Lyophilizers
- Autoclaves
- Depyrogenation Ovens
- Barrier Isolators
- Fluid Bed Dryers
- Fermentors
- Pasteurizers
- Mills and Granulators
- Glassware and Stopper Washers
- Packaging Equipment and Lines
- Filling Equipment and Lines
- Transfer Systems
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Critical Utilities/ Facilities Commissioning and Qualification
Commissioning and Qualification of Facilities and Utilities are key elements in determining that the quality assurance standards of a pharmaceutical product or medical device are met. The goal to ensure, with a high degree of confidence, that the facilities and utilities supporting the manufacture and testing of a product consistently meet pre-determined specifications, and that successive lots of the product are acceptable as per FDA guidelines.
Commissioning Experience includes:
- New Facility Commissioning
- Retrofit Commissioning
- Decommissioning
Utility and Facility Qualification experience includes:
- Aseptic Facilities
- Solid Dose Facilities
- In Vitro Diagnostic Facilities
- Clinical Facilities
- Water For Injection Systems
- HVAC systems
- Critical Air and Gases
- Clean Steam
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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:
51 Veriteq VL2000 data loggers
5 complete Kaye Validator 2000 systems
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, incubator
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Stability chamber
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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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