ICHQ3D introduced for APIMF and API prequalification procedures
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The ICHQ3D guideline presents a process to assess and control elemental impurities in drug products using the principles of risk assessment.
Report on the international API inspection programme 2011 - 2016
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In April 2018, EMA published a report with an overview of the activities of the programme between 2011 and 2016.
First amikacin injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Quality Control Laboratory (QCL)
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New addition to the List of Prequalified Quality Control
HLL’s levonorgestrel prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list: