GE Healthcare Life Sciences. Validation Services. Compliance support through life cycle management

Transcription

1 GE Healthcare Life Sciences Validation Services Compliance support through life cycle management

2 Validation Services Validation Services is an independent product and service provider within GE Healthcare Life Sciences that offers validation support and documentation. To date, we have supplied validation documentation for almost 5,000 biopharmaceutical and pharmaceutical projects. Facilities that have used GE Healthcare Validation Services have reported numerous examples of successful audits by the FDA and other regulatory bodies. GE Healthcare Validation Services ensures efficient verification of your GE Healthcare equipment compliance status, based on current interpretation of regulatory directives and guidance. Our documentation supports your equipment throughout its entire life cycle. When you choose GE Healthcare as your provider of validation support, you can be confident that your equipment is operating in a reliable, consistent, and GxP-compliant manner. 2

3 Life cycle support Historically, equipment qualification was considered a one-off activity necessary for equipment operation in a regulated environment. However, the regulatory landscape has changed regulations now require a validation life cycle approach to demonstrate compliance throughout the equipment s working life. GE Healthcare takes your investment in our equipment very seriously, and we provide a comprehensive suite of validation services to support your equipment throughout its entire life cycle. With our life cycle validation approach, you benefit from a service that begins with purchase planning and includes installation, maintenance, utilization, and decommissioning of your equipment. Purchase planning: Customized approaches to documentation and validation Validation impact assessment Detailed description of equipment qualification approach Installation: Installation and Operational Qualification (IQ / OQ) documentation IQ / OQ performance Decommissioning: Decommission your system Prove status of a validated system after the last production cycle Maintenance and utilization: Change Control Protocol (CCP) documents Continuous Verification ValidationCare subscription 3

4 Accelerate your product s time to market Each day a new biotherapeutic is in process development rather than on the market, you incur significant costs. To stay competitive, it is imperative that regulatory compliance is achieved efficiently on production facilities as well as laboratory systems and processes. Adopting a risk-based strategy will reduce errors and minimize the need for repeat runs at the last crucial and time-pressured stages before a candidate drug can enter production and the market. Validation Services GE Healthcare equipment and software are developed and verified according to structured and documented procedures. This accelerates leverage of validation activities and results in a much faster qualification phase, minimizing the time to start-up at your site. Furthermore, our standardized test methodologies and modular documentation format enables efficient validation life-cycle activities such as Change Control Protocols and Continuous Verification following equipment upgrades and relocations. Traditional validation method GE Healthcare Validation Services approach GE Healthcare s approach to validation results in significant time savings relative to traditional validation methods. Customer surveys have shown substantial time savings with the utilization of GE Healthcare IQ / OQ services compared to relying on consultants or internal resources. Consultants In-house validation teams Survey results Average equipment supplier GE Healthcare Typical time to delivery Working days Differences in delivery time of IQ / OQ documents to biopharmaceutical companies.

5 Benefits of engaging Validation Services Significantly faster equipment qualification The peace of mind that comes with a proven history of support for GxP-compliant equipment and customer satisfaction including world-leading pharmaceutical and biotech companies Consistent validation support from our global network of field support and cgmp*-trained service staff Predictable costs and timelines Validation service offerings GE Healthcare offers a comprehensive suite of validation services to support your equipment through its entire life cycle. Our validation tests and protocols are developed and approved by validation experts. Our approach is in alignment with GAMP5, ICH Q8-10 and ASTM E2500, whereby validation activities and documentation focus on what is critical for end-product quality and are scaled according to risk, complexity, and novelty. Our comprehensive range of regulatory documentation, services and support for GE Healthcare equipment includes: Customized document and qualification approach We can customize the validation to accommodate your specific needs. GE Healthcare Validation Services can design customized Commissioning and Qualification programs to facilitate testing during the Factory Acceptance Tests / Site Acceptance Tests (FAT / SAT) qualification phase. Modular document framework Consistency and quality are critical for successful compliance. It is well-accepted that a consistent documentation package is indicative of the quality of the work it records. At GE Healthcare, we fully understand your needs and have developed a LEAN approach to documentation, combined with the latest information technology tools, to ensure packages of unsurpassed consistency within the shortest time frame. We designed our modular validation strategy to provide active support and compliance during the life cycle of a system and to minimize the impact of life-cycle change. This increases accuracy, versatility, and speed well beyond traditional validation approaches. *Current Good Manufacturing Practice 5

6 Change Control Protocols Change Control Protocols (CCP) help you verify the compliance status of your equipment after software and / or hardware upgrades, or following a system move. Continuous Verification Regulatory authorities require instrumentation in a GxP environment to be qualified before use and periodically evaluated thereafter to confirm they remain in a validated state, are compliant, and are fit for their intended use throughout their life cycle. A validation life cycle approach enables continuous process and system improvements while maintaining your equipment in a validated state as you gain experience in system use. Continuous compliance verifications are recommended in conjunction with: Preventive Maintenance Product changes (new production campaigns) Equipment breakdowns The use of a standard set of documents saves time for requalifications and ensures the maintenance of equipment in a qualified state. Requalifications and CCPs can be combined in a GxP services context for predictable compliance support throughout the product life cycle. Decommissioning Decommissioning requires the repetition of appropriate sections of the validation process to retire equipment and to prove the status of a validated system or manufacturing process following the last production run that uses the equipment designated for decommissioning. Our combination of automated modular document generation and risk-based validation approach is what sets us apart Mats Pettersson, Section Manager Validation Services, GE Healthcare BioSciences AB Reduce waste and increase efficiency Eliminate the piles of paper traditionally associated with FAT / SAT-IQ / OQ and replace them with a modern, efficient approach that combines the benefits of risk management and expert know-how from industry-leading professionals. 6

7 7

8 GE, imagination at work and GE monogram are trademarks of General Electric Company. All third party trademarks are the property of their respective owners General Electric Company All rights reserved. First published Dec All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare representative for the most current information. GE Healthcare UK Limited Amersham Place Little Chalfont Buckinghamshire, HP7 9NA UK GE Healthcare Europe, GmbH Munzinger Strasse 5 D Freiburg Germany GE Healthcare Bio-Sciences AB Björkgatan Uppsala Sweden GE Healthcare Japan Corporation Sanken Bldg., , Hyakunincho Shinjuku-ku, Tokyo Japan For local office contact information visit: / contact GE Healthcare Bio-Sciences Corp. 800 Centennial Avenue Piscataway, NJ USA AB 03 / 2011