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BioTeknica provides proven validation methodologies that have been successfully implemented for our clients at both small and large Medical Device and Pharmaceutical manufacturers.
Inadequate validation is a common source of FDA 483 findings. Responding to them can be costly and disruptive, especially if it requires the validation of your legacy products, test methods, equipment, and processes. If just one validation segment doesn’t meet regulatory standards, it can negatively impact your organization. We enhance your future bottom line by characterizing, optimizing, and thoroughly validating your production processes and systems.
– A comprehensive quality system record that captures the inventory of products and associated manufacturing processes, equipment, test methods, facilities and utilities and their validation status as well as plans to address new products or items and/or revalidation objectives.
– Commissioning protocols and reports demonstrate that design requirements are met and are then ready to proceed to validation where it will be demonstrated that key environmental control and process utility supply requirements are satisfied.
– Installation (IQ), Operation (OQ), and Performance (PQ) qualification protocols and reports to demonstrate that equipment is installed properly, and can successfully produce in-process and final products that meet specifications over the intended process parameter(s) operating range including worst case situations.
– Analytical, physical, mechanical, and visual test method characterization and validation protocols and reports demonstrate that the Manufacturing and Quality Control test methods can readily detect a nonconforming product with a high degree of assurance.
– Cleaning validation including determination of equipment process train vs. product use vs. cleaning method, determination of contamination limits, sampling methods and analytical test methods, and worst-case challenge testing.
– Computer validation following GAMP guidelines including user and functional requirements, risk assessment, and Software/Hardware Verification & Validation plans, protocols, and reports that demonstrate that automated manufacturing and quality systems meet all requirements.
– Protocols and reports that demonstrate the overall production process, from start to finish, including all sub-processes can successfully produce final products that meet specifications under nominal conditions.