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In order to ensure extraneous production materials are not available a line clearance must be done prior to any production activities.
What is meant by line clearance?
The term line clearance is understood to mean the checking that the equipment and workplace have been cleared of all products, documents and materials from previous packaging orders not required for the current order and that the equipment is clean and ready for operation.
What are the 3 Cs of line clearance?
The 3 Cs of line clearance, which are cleanliness, compliance, and confirmation, play a crucial role in maintaining pharmaceutical industry standards and preventing cross-contamination or mix-ups. Cleanliness is the first and foremost aspect of line clearance.
What are the requirements for line clearance?
Line clearance should ensure that all materials, products, labels, and records from previous operations have been removed. The person responsible should initial the batch record to show that a clearance check has been carried out. The line should be clearly labeled to show the product and its strength to be packaged.
What is line clearance in FDA?
Line clearance is the physical procedure of clearing the space, equipment and materials used in manufacturing to get ready for the production of a new medical device.
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