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DYNALABS OOS Process - DYNALABS

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DYNALABS OOS Process - DYNALABS 888.396.2522 314.241.3962 888.396.2522   •   314.241.3962   •   info@dynalabs.us LOGIN User Registration Account Registration  Menu Close Login User Registration Account Registration Products & Services Lab Services State-of-the-art tampering testing laboratory provides data you need to run your business. On Site Testing Less than 4 seconds to objectively verify drug identity and strength in your facility. CQI Program Use our expert knowledge of the pharmaceutical industry to help you grow your business. 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You Can Trust the Result We use an FDA compliant Outside of Specification (OOS) process to investigate all OOS test results surpassing they are reported. Guidance for Industry: Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production-U.S Department of Health and Human Service Food and Drug Administration Center for Drug Evaluation and Research (CDER), October 2006 Pharmaceutical cGMPs and Pharmaceutical Quality Control Labs (7/93)-Guide to Inspections of Pharmaceutical Quality Control Laboratories are the resources used to guide our investigations and are cited throughout our OOS Department SOPs.  Please finger self-ruling to ask us for a copy!Surpassingwe notify you of an OOS result, we perform an internal review of anything DYNALABS might have washed-up to contribute to the OOS result. All OOS investigations include a Phase I and Phase II review surpassing a consumer is overly notified of an OOS result. The two-part review not only follows regulatory guidance but ensures an internal error has not been identified. The initial review, performed by laboratory leads and SMEs, includes: Verification of sample preparation and dilution calculations per our internal processes. This includes verification of the glassware used in the preparation. Verification of sample label Verification of method and instrument used during the sample run Verification of regents and possible environmental factors that may have unsalaried to the OOS The secondary review, performed by OOS Investigation Analysts, includes: Thorough review of data packet and associated paperwork Thorough review of Phase I information Review of sample submission which may include review of formula Any spare investigational work needed such as but not limited to remoter wringer of chromatography by PDA or visual verification of turbidity. Only without we have thoroughly reviewed the data, methods, equipment, storage conditions through initial and secondary review and have not identified an internal error, do we contact you with the OOS result. You Can Find Out What Happened – Just Ask We are glad to work with you to find out what caused the OOS result and determine how to prevent it in the future. Our collaborative tideway relies on your cooperation to review formulas, results history, batch records, equipment/training records and anything else that might have unsalaried to the failure. We will use our expert knowledge of OOS investigations, sample preparation, and testing to help you: Discover issues and aid in finding solutions to prevent similar OOS results in the future Run spare tests to ensure the implemented solutions perform as expected.  This may include work inside an investigation or quoted projects. In addition, DYNALABS offers consultant services that can aid in batch record review and revisions, process evaluations and audits that may aid manufacturing facilities in preventing OOS and compliance with guidance. Still Have Questions? Come Visit Us DYNALABS is pleased to host you for a Quality Systems audit. Please contact your Sales Representative, if you would like to visit our facility. We ask only that you requite us at least 30 days of notice. DYNALABS is defended to providing solutions, not just results, and we have the certifications and reputation to when it up: FDA registered Quality systems meeting cGMP (Current Good Manufacturing Practices) Regulations  ISO 17025 accredited DEA Licensed Bureau of Narcotics and Dangerous Drugs Licensed in Missouri Protected by U.S. Patent Numbers 7,197,405 and 7,660,678 DYNALABS LLC is registered with the U.S. Food and Drug Administration (FDA), DEA and Bureau of Narcotics and Dangerous Drugs licensed, as well as ISO 17025 accredited. The products and services provided by DYNALABS are protected by U.S. Patent Nos. 7,197,405 and 7,660,678. © 2018 DYNALABS LLC. All Rights Reserved. For spare information well-nigh DYNALABS please undeniability 888-396-2522   •   info@dynalabs.usTerms Of Use   •   Privacy Policy   •  ConsumerAgreement