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Qualification & ValidationIPA Consulting Services is a preferred partner to many organizations in the Pharmaceutical, biotechnology, API, veterinary, and Natural Health Products across the world and is known for its quality, professionalism, performance and solutions. Dedication to quality, personalized support and the success of your projects are the key for our success. You receive a cost effective validation strategy while providing the highest quality service conducted with the strictest confidentiality. Our highly experienced validation associates have both skills and commitment to provide a superior service required to meet all of your validation and calibration, qualification, and commissioning needs in order for your organization to remain competitive, dynamic and achieve a new level of confidence. They have worked with many facilities, systems and equipment including; (WFI, clean compressed air, and HVAC), Aseptic Systems (autoclaves, depyrogenation ovens and tunnels, cleanrooms, vial washers); Biotech Systems (bioreactors and fermentors, cell harvest), APIs (reactors, mills, centrifuges) and Solid and Liquid Dosage products (blenders, tablet presses, solution prep, liquid fill machines). By providing hands-on validation support, qualification templates, preparation and execution of validation and compliance documents, we can relieve short term workloads that can exceed your available resources. We offer a comprehensive list of services including; Cleaning Validation, Process Validation, Computer Validation, Facility Qualification, Equipment Qualification, Temperature Mapping and much more. When it comes to qualification and validation services, our team brings a vast amount of experience to the table in order to achieve the best in innovative solutions for your new or existing facilities. Our services include the followings: Facilities, Critical Utilities and Equipment Qualification
Process Validation
Process Validation provides documented evidence with a high degree of certainty that a process will consistently produce product meeting its pre-determined quality attributes. Process Validation typically occurs after the Installation Qualification (IQ), Operational Qualification (OQ), and (when required) a Performance Qualification (PQ) have been satisfactorily completed. Successful process validation requires thorough process development, identification of controlled and critical parameters and in-process and final product specifications. Typically a minimum three (3) consecutive lots of product meeting the established quality specifications are necessary for process validation. These three consecutive lots are completed at the boundaries of critical parameters. Cleaning ValidationCleaning validation is documented proof that one can consistently and effectively cleanse a system or equipment item. The objective of cleaning validation is to ensure that a specific cleaning process will consistently clean to predetermined limits so as to prevent contaminants (product or cleaning process related) from leaving residues that will adulterate and adversely affect the safety and quality of the next product manufactured.
Computer Systems and Software ValidationComputerized Systems that perform regulated functions must be qualified or validated. Computer validation requires a cross-functional skill set that encompasses IT expertise, working QA knowledge (including GXP practices and computer validation), business acumen, and software modeling. IPA Consulting Services validation team understands GAMP and software development lifecycle methodology. Having specialized skill sets, our team offers a complete range of services for your computer validation needs. We EXCEL at SAP, TrackWise, Delta V, and custom software validations! We offer complete outsourced Quality Assurance services for software implementation and validation projects!
Calibration and Metrology Services
Other Services
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