The British MHRA has joined an Australia-Canada-Singapore-Switzerlan Consortium to explore opportunities for information and work-sharing.
In addition to the new USP Chapter <1567> Pyrrolizidine Alkaloids announced recently, the USP is proposing a new chapter entitled <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs).
In last week's newsletter you could read about part I of Q&As on cleaning validation - asked during ECA's first Cleaning Validation Online Training Course in September. The ECA would like to share a selection of these Q&As on Cleaning Validation - now in part II.
A repacker in the US has recently received a Warning Letter from the FDA. The described deficiencies are repackaging of products in non-equivalent primary packaging, the lack of cleaning validation and the establishment of a suitable quality unit.
About 2.5 years ago, the FDA announced a Guidance for Industry on Computer Software Assurance (CSA). However, this guidance has not yet been published. Currently, GAMP Francophone has published a first position paper on this issue.
A US-American pharmaceutical manufacturer has recently received a Warning Letter from the FDA due to deficiencies in packaging and quality assurance.
In September the ECA offered the first Cleaning Validation Online Training Course - with many questions for the speaker. The ECA would like to share a selection of these Q&As on Cleaning Validation with the community.
Due to the Covid-19 pandemic, on-site audits by Notified Bodies are partly only possible to a limited extent or not at all. What are the alternatives? A guideline of the Medical Device Coordination Group (MDCG) provides information on this.
Medical devices are essential medical tools and that is why health authorities are also interested in their development. For this purpose, the FDA has presented a catalog of tools for the development of medical devices.
The reprocessing of single-use devices in the medical device sector is left to the EU Member States. However, only the national law of the respective member states must allow this. Now, an implementing regulation is available which describes common specifications for reprocessing single-use devices.