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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 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.
First article inspection is typically a purchase order requirement of the purchaser for the supplier to complete. If the manufacturer doesn't have the in-house capability or if the purchaser requests, the first article inspection may be conducted by an approved subcontract supplier such as a dimensional inspection/metrology laboratory.
Risk-based inspection (RBI) is an optimal maintenance business process used to examine equipment such as pressure vessels, quick-opening closure - doors, heat exchangers, and piping in industrial plants. RBI is a decision-making methodology for optimizing inspection plans.
The history of testing, inspection and certification services spans back several centuries. In the late 19th century, following the advent of the Industrial Revolution and the considerable risks involved with high-pressure steam boilers, specialized institutions emerged across Europe which carried out periodical inspections of such vessels to assess their overall condition as a precautionary ...
A building inspection is an inspection performed by a building inspector, a person who is employed by either a city, township or county and is usually certified in one or more disciplines qualifying them to make professional judgment about whether a building meets building code requirements.
The U.S. drug regulator is set to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs, a top executive for the Food and ...
Inspection and measurement of the thickness of the different layers of an electronic chip using THz and X-ray radiation. THz has the privilege of being non-ionizing (non-destructive) but the resolution of X-ray is higher. [2] Quality related in-process inspection/verification is an essential part of quality control in manufacturing.
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related to: fda checklist for inspections and standards of construction equipment