Cleaning validating individual pieces of equipment
All set-up information is documented and samples are collected at the end of the integrated process based on ANSI/ASQC Z1.4-1993 general inspection levels and acceptance quality levels established by the end user.Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.” Computer System Validation KARMA LAB will develop each of the various aspects of Computer System Validation. Karma Lab is able to define, document and implement the process of documenting and testing all the various aspects of a computer based control system/process, from its inception through its design, build and installation, and all the way to its eventual decommissioning.
a packaging line consisting of several pieces of equipment, Incubators, Sterilization Autoclaves, Depyrogenation Tunnels, Ovens, Cold Rooms, Freeze Dryers, etc… Performance Qualification Protocols test the performance and critical parameter testing for each individual piece of equipment on an integrated process.
Among those listed, the FDA claimed the manufacturer had failed to provide a written record of major equipment cleaning, as required by Title 21 of the Code of Federal Regulations, section 211.182.
Specifically, the agency cited a failure to document the daily cleaning and sanitizing of aseptic fill lines.
If you think equipment and utensil cleaning are tasks best left for rainy days, consider the case of Ganes Chemicals Inc.
(Carlstadt, NJ), a 75-year-old manufacturer of active pharmaceutical ingredients (APIs).