As part of inspections the authorities also check computerised systems. Klaus Feuerhelm, former inspector at the Regierungspräsidium Tübingen, has created a TOP 3 list of the most frequent complaints for 2020. TOP 2 of the list - system descriptions. What were the deficiencies found here?
The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to review the batch documentation?
The EMA published the final reflection paper on "Similarity". The paper shows how statistics should be used in drug development when a comparative assessment of quality attributes (QAs) needs to be made for pre- and post-manufacturing changes, biosimilar development as well as generics development.
It is official now: the EU Commission has confirmed the full functionality of the Clinical Trials Information System in the Official Journal of the EU. This means that the Clinical Trials Regulation 536/2014 (CTR) will become applicable on 31 January 2022. What are the GMP / GCP changes associated with this?
The FDA is warning against certain hand sanitizers because of side effects and contamination, especially during the COVID-19 pandemic. The latest notifications concern alcohol-based hand sanitizers.
Near infrared (NIR) analytical procedures are widely used in the pharmaceutical industry for identification testing and assay measurements and for monitoring and controlling manufacturing processes. In this context, the U.S. Food and Drug Administration (FDA) has published a new Guidance for Industry entitled Development and Submission of Near Infrared Analytical Procedures.
Parenterals must be 100% visually inspected. This is a clear requirement of the pharmacopoeias, just as it is clear that containers with particles must be sorted out. But do the particles found always have to be identified?
During an inspection the FDA found insufficiencies around access authorization. Read more about remediation activities required by the US FDA.
In a recently published Warning Letter sent to a Chinese company, the FDA criticises, among other aspects, that analytical test methods were not adequately validated and no system suitability requirements were present.
Computerised systems are also audited as part of inspections by the authorities. Klaus Feuerhelm, former GMP inspector at the Regierungspräsidium Tübingen, has compiled a TOP 3 list of the most frequent complaints for 2020 based on his inspections. TOP 1 on the list is the audit trail review. What deficiencies were found here?