IPEC e-newsletter - Excipients Insight April 2017 - 30-04-17


Inside this issue


Recommended reading

Continuous manufacturing is driving more focus on excipient fitness for purpose

The deployment of continuous manufacturing (CM) is prompting the pharmaceutical industry to understand better the characteristics of the excipients they are using and work more closely with suppliers to assure that the materials are fit for purpose. CM is also prompting a harder look at how to open up the clearance pathway for new/modified excipients that would better serve the advanced processing needs and objectives.

IPQ News

Industry asks US FDA to 'pause' data quality reporting plan

API, excipient and drug industry groups have reiterated concerns about the latest iteration of the US FDA’s “quality metrics” reporting requirements. 


UK triggers Brexit: what's next for the UK, MHRA and EMA?

UK Prime Minister Teresa May on Wednesday set in motion the UK’s departure from the EU over the next two years, guaranteeing the European Medicines Agency (EMA) will see some significant changes over the next few years.


Chinese and US Pharmacopeia projects keep the CRC busy

The name sounds solemn and serious – Compendial Review and Harmonization Committee (“CRC”) – and while the subjects with which they deal are indeed very weighty, the pace and volume of their work belies the slow-moving, bureaucratic impression which the name may evoke.

IPEC-Americas Insider

Understanding how excipients affect drug quality

In implementing Quality by Design for drug formulation, it is crucial to identify the critical properties of excipients and understand how their variation affects the final drug product.


EMA-FDA QbD pilot program led to further harmonization

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further harmonization of concepts introduced through the International Council for Harmonisation (ICH).


ECA reviews use of hoses in the pharmaceutical industry

Hoses are omnipresent in the production of medicinal products, but can present a range of disadvantages compared to permanently installed pipes, says the European Compliance Agency (ECA). Hoses need to be qualified before use. In the course of qualification, some elements must be checked or determined such as cleaning, disinfection, sterilisation, intended purpose (single / multi-use), i.e. leach out, examination of the inner surface, particle release, durability, test procedure.





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