Cleaning validating individual pieces of equipment
Another API manufacturer was told in November that its c GMP deviations, including failure to validate cleaning and maintenance of critical equipment, had rendered its products adulterated.Even industry giants need reminders about the importance of cleaning. received a warning letter from the FDA that identified “numerous significant” deviations from c GMPs at its Kalamazoo, MI, operations.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.” Performance Qualification Protocol KARMA LAB can develop Performance Qualifications to validate a complete integrated process (e.g.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.As part of the IQ all such documentation will be identified and referenced.“Equipment manufacturers can also use and execute our protocols as a Dry Run prior to shipping the equipment. First, if something is wrong, the equipment manufacturer will discover it while the equipment is still under its full control at its site where all the resources and personnel are readily available to deal with the situation.Every company involved in the pharmaceutical industry should take cleaning as seriously as the FDA does, says Dr.
First among the five items cited: Cleaning procedures for non-dedicated reaction vessels, holding vessels, recrystallizers, centrifuges and dryers used to produce APIs and intermediates had never been validated.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.These companies have learned that no segment of the pharmaceutical industry is exempt from the FDA's cleaning validation requirement.That includes manufacturers of dosage form medications, biotech firms working with living organisms, medical device manufacturers, chemical companies supplying active ingredients, contract and government facilities, and the new nutraceutical manufacturers.