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level: Level 3 Definition of terms

Questions and Answers List

level questions: Level 3 Definition of terms

Question	Answer
All CONTROL MEASURES taken designed to ensure that finished products consistently conform to established specification of identity, strength, purity and quality.	Quality Control
An act of HOLDING OFF A MATERIAL for use, or a product for packaging or distribution by physically setting it apart or by system duly validated, PENDING a decision on release or rejection.	Quarantine
All substances whether active or excipients that are employed in the processing of a finished product.	Raw Material
A RESOLUTION between the THEORETICAL and ACTUAL yield.	Reconciliation
The INCORPORATION of all or PART OF PREVIOUS BATCHES with the required quality into ANOTHER BATCH at a defined step of production.	Recovery
The STATUS OF MATERIALS or products which are NOT PERMITTED to be used for processing, packaging or distribution.	Rejected
The STATUS OF MATERIALS or products which are PERMITTED to be used for processing, packaging or distribution.	Released or Passed
A SAMPLE REPRESENTING the lot, the batch, or the total amount of materials based on a sampling plan.	Representative Sample
The REWORKING of all or part of a batch of product of an UNACCEPTABLE QUALITY from a defined step of production in order that its quality may be rendered acceptable by one or more additional operations.	Reprocessing
Any FINISHED PRODUCT which is already in distribution and SENT BACK to the manufacturer or distributor due to complaint, damage, expiration, validity or other reasons such as the condition of the container or package which may cast doubt on the product identity, quality, strength and safety.	Returned Product
All measures taken to assure SUITABLE or adequate environmental CONDITIONS in compliance to GMP.	Sanitation