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