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It is used when observing a physical process, to record actions as they happen, and thus get an accurate description of the process. It is used when analyzing the steps in a process, to help identify and eliminate waste—thus, it is a tool for efficiency planning. It is used when the process is mostly sequential, containing few decisions.
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
The FDA has the authority to inspect any establishment in which food is manufactured, processed, packed, or held. [16] In searching for contamination, the FDA typically uses organoleptic inspection methods – investigators trained to distinguish contamination and decomposition by sight and smell.
Hazard analysis critical control points, or HACCP (/ ˈ h æ s ʌ p / [1]), is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level.
The firms that are overdue for safety and quality inspections represent about 42% of the 4,700 plants that are currently registered to produce drugs for the U.S. and previously underwent FDA ...
Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
A First Article Inspection (FAI) is a production validation process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report.