The FDA launched the development of an enhanced electronic, interoperable U.S. track-and-trace system for industry set to go into effect in 2023.
Quality Metrics can support both companies and regulators to guarantee a high quality performance and the continuity of quality product supply.
The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 1: Must there be a concept for evaluating the criticality of data? And what rules for entering critical data into computerised systems must be available? The answers to both questions can be found here.
What happens if a certificate is issued before the withdrawal date but released after this date? New Q&As give a clear answer.
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2017 to March 2018.
The European Commission has published version 13 of the Questions & Answers document regarding the implementation of the rule on safety features for medicinal products for human use.
The European Medicines Agency (EMA) has started with the relocation to the Netherlands and informs about contact details and continuation of the main activities.
To face a possible Hard Brexit, UK plans to amend EU GMP Guidance.
The EMA recently released comments gathered during its public consultation for the ICH Q12 draft guideline. Read more about EMA ´s overview of comments received on ICH Q12 on pharmaceutical product lifecycle management.
To face the possibility of a Hard Brexit, the MHRA has issued updated guidance proposing some necessary arrangements in regard of Clinical Trials of IMPs.