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Equipment: Performance Validation Program - DYNALABS

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Equipment: Performance Validation Program - 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. Continuous Quality Improvement (CQI) Consulting Services Customer Improvement System Customer Production System Data Analytics Laboratory Services Test Services Lab Services API (Active Pharmaceutical Ingredient ) list DVx™ On site Drug Verification DVx™ Specifications DVx™ Validation Process DVx™ General FAQs On-site Managed Services Consulting Improvement Systems Production System Six Step Approach DYNALABS OOS Process Online Services Sample Submission Customer Service What We DoHospital Pharmacies Stability of Drug Diversion of Drug In House Training Product Validation Drug Investigation Compounding Pharmacies People: Training Validation Program Materials: Vendor Qualification Program Equipment: Performance Validation Program Process: Process Validation Program Product: Product Validation Program Frequently Asked Questions CompanyOur Story Announcements Announcing a new National Accounts Manager, Christine Versichele. DYNALABS announces new Chief Technology Officer DYNALABS welcomes a new Principal Consultant DYNALABS embarks on $1.2 million expansion DYNALABS Announces a New Vice President of Sales DYNALABS announces Director of Quality & Regulatory Affairs DYNALABS LLC Named One of Inc. 5000 Fastest-Growing Private Companies in 2017 DYNALABS named to the 50 Fastest Growing Companies of 2017 DYNALABS Enhances Antimicrobial Effectiveness Testing for USP Potency Testing for Oxytocin DYNALABS Announces New President DYNALABS investment doubles the size of its testing facility Custom Packing Slip DYNALABS Receives ISO/IEC 17025 Accreditation Entrepreneurial Success SmallMerchantryof the Year 2016 DYNALABS investment doubles the size of its testing facility Enforcing FDA Labeling Policies Entrepreneurial Success Award Events Registrations and Awards Vision, Mission Leadership Partners and Alliances Investor Information ResourcesWebinars Blogs Industry News FDA to Remove APIs from list FDA Drug Shortages The Pharma Reports The Pharma Report | Sept 2018 Tech Bulletin | June 2018 Tech Bulletin | May 2018 Tech Bulletin | April 2018 Tech Bulletin | March 2018 Tech Bulletin | February 2018 Tech Bulletin | January 2018 Tech Bulletin | December 2017 Careers Contact < Home | What We Do | Compounding Pharmacies | Equipment: Performance Validation Program Equipment: Performance Validation Program OBJECTIVE To develop forfeit effective, efficient programs to validate the performance of specific pieces of equipment used for making compounded medications. BACKGROUND Equipment used for compounding medication needs to be validated to be operating properly. There are three hair-trigger activities associated with equipment validation: Installation Qualification: Was the piece of equipment install properly? For example, are the utilities and environmental factors towardly for the proper operation of the piece of equipment? Operational Qualification: Is the piece of equipment operating in a way in which it was designed? For example, does it start, run, and shut lanugo properly? Do lights, bells, and whistles vivify when they are supposed to? Performance Qualification: Does the piece of equipment unceasingly produce the quality of product for which it was designed? As with anything, validating the equipment is working properly may be a troublemaking and expensive exercise, if not washed-up properly. OUR APPROACH DYNALABS focuses on helping with the Performance Qualification speciality of Equipment Validation. Data created during the Process and Product Validation may be used in part for the Performance Qualification of the equipment as well. If there are issues with the equipment during process validation, these issues will be addressed with solutions. The process for developing a Performance Qualification Program is as follows: Identify the various pieces of equipment used for compounding Determine the hair-trigger pieces of equipment requiring validation Installation and Operation qualification status Establish plan for Performance Qualification of hair-trigger equipment IMPACT TO THE PHARMACY Minimize the forfeit of equipment validation Minimize financing associated with reworks and discards Optimize time and financing associated with equipment failures Lower probability of litigation due to product not meeting label claims 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. 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