15 Questions
In-process quality control includes batch release of excipients.
True
Testing of raw materials is not a part of in-process quality control.
False
Quality control only occurs at the finished product stage.
False
Testing of retained samples is a type of in-process quality control.
True
In-process quality control does not include testing when deviations to manufacturing occur.
False
Documentation related to Batch Manufacturing Report (BMR) should be retained by the QC department for at least 6 months after the expiry date of the batch.
False
Technical Notebooks (TNBs) are not recommended to be readily available for the purpose of comparison of data.
False
Procedures and calibration records of instruments & equipment should not be part of the documentation available to QC.
False
Sampling Procedures do not need to include instructions for any sub-division of a sample for multiple analysis.
True
Data from environmental monitoring is not a required documentation element for QC.
False
Analytical reports and certificates of authentication (COA) are only issued for finished products, not raw materials.
False
In-process controls do not need to be performed using methods approved by Quality Control.
False
Laboratory reagents intended for prolonged use do not need to be marked with the preparation date and expiry date.
False
Analytical reports can only be used for reporting quality inspection results, not cleaning results of manufacturing equipment.
False
All testing operations described in the marketing authorization should be carried out according to the methods outlined in the Red Guide.
False
This quiz covers the responsibilities and examples of testing conducted as part of manufacturing processes, such as batch release of excipients, active testing of packaging components, intermediates testing, and more.
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