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Rework is the process of correcting defective, failed, or nonconforming items after inspection. This process includes disassembly, repair, replacement, and reassembly.
What is the difference between rework and reprocess?
Rework, on the other hand, involves modifying the process with additional steps not originally included in the validated manufacturing process. This is done to correct defects or deviations that cannot be addressed by simply repeating existing procedures.
What is a rework procedure?
Rework is an unincorporated food product kept for subsequent use or reprocessing. Examples of reworking may include: re-forming meat patties rejected for being broken, underweight or improperly breaded.
What is a rework in FDA?
Measures in the bill are intended to prevent pharmaceutical companies from blocking companies from producing generic drugs by refusing to sell drugs to the new companies, or taking advantage of safety regulation to block new drugs. Generic drug companies would be allowed to sue to gain access to samples.
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FDAs Pre-Approval Inspection (PAI) Program and How to
by CDRD DiGIulio Cited by 4 A pre-approval inspection (PAI) is performed to contribute to FDAs assurance that a manufacturing establishment named in a drug application is capable of
42 CFR 488.5 - Application and re-application procedures
A national accrediting organization applying to CMS for approval or re-approval of an accreditation program under 488.4 must furnish CMS with all of the
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