The new ISO TR ISO/TR 24971:2020 Guidance on Risk Management for medical devices has been published last month. This Technical Report provides additional guidance on how to implement a Risk Management System according to ISO 14971.
Once again, the lack of laboratory data integrity, beside other observations, caused the issuance of a US-American FDA Warning Letter and resulted in deficiencies mainly focused on the solvent recovery processes.
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes new Q&As relating to pharmacovigilance activities like CAPAs, Audits and Remote-Inspections.
The recently published final assessment report of the CHMP describes in great detail the state of knowledge on nitrosamines in human medicinal products. All you need to know about risk assessment, calculation of limit values and analysis of nitrosamine contamination can be found in this document.
The costs for construction - but also for reconstructions - vary considerably. Tenders for this also often vary considerably. Currently, there are two interesting developments in this area: the increased use of bending machines and the renunciation of chemical passivation. Read more here.
The European Medicines Agency (EMA) has published the final version of its guideline on the use of the different pharmaceutical water qualities. The revision had become necessary due to the possibility to produce WFI using methods other than distillation. Read more here.
Regulatory authorities around the world want to work together more closely on the basis of Covid-19 and have identified three areas for this: research during pregnancy, medicines in clinical trials and monitoring of vaccines. Read more here.
In order to ensure a smooth and efficient cooperation between the authorities and marketing authorisation holders even in the times of Covid-19, the documentation and templates to facilitate the handling of marketing authorisations have now been bundled, listed and published on the website of the HMA (Heads of Medicines Agencies).
On 14 April 2020, the Brazilian regulatory authority ANVISA published a new guideline for the validation of computerised systems which is to replace the guideline of the same name from 2010. Find out more about the main contents and further developments here.
In this Warning Letter from the FDA to a manufacturer of unauthorised tissue-based products, deficiencies in current Good Tissue Practice (cGTP) and violations of fundamental GMP regulations are described.
The European Pharmacopoeia (Ph. Eur.) has published the revised chapter 2.2.48 on Raman Spectroscopy for public consultation. All interested users are encouraged to review the draft and submit their comments from July to September 2020.
The World Health Organization (WHO) has published a draft proposal for revision in The International Pharmacopoeia. The document entitled DISSOLUTION TEST FOR SOLID ORAL DOSAGE FORMS will be posted on the WHO Medicines website. The deadline for comments is 31 August 2020.
The drafts for the new Ph. Eur. chapters on plastic packaging materials (COP, COC, and Extractable elements in plastic materials for pharmaceutical use) have been re-published in Pharmeuropa to give stakeholders sufficient time to comment.
The European Commission, the HMA and the EMA released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document includes flexible approaches for adverse reactions reporting and labeling.
The Good Distribution Practice for Active Substances Guidance on interpretation and implementation has been published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute.