In this week’s news, EMA advises API sector on nitrosamine testing, US FDA firms up device ID rules and more…

EMA updates advice on nitrosamine testing and reporting

The EMA has updated its advice on nitrosamine testing in a new Q&A document published last week.

The document here outlines how manufacturers should assess the risk of nitrosamine impurities in drugs and how to test products.

The update includes advice on reporting requirements for product line extensions, explaining that “No risk evaluation is generally necessary when submitting line extension or variation applications.”

Nitrosamine is a potentially carcinogenic impurity that has been detected in various APIs and pharmaceutical products over the past few years.

US FDA finalizes UDI rules for medical device makers

The US FDA has finalized its guidance on unique device identifiers (UDI) used to track medical devices.

The guidance document sets out the requirements for a UDI, explaining that it must be written in easily readable plain-text form or in a form that is compatible with automatic identification and data capture (AIDC) technology.

The FDA wrote that “the aim is to set out the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule.”

PIC/S new inspection data guidelines for regulators

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published new data management and integrity guidance for pharmaceutical manufacturers and distributors.

The document  is designed to help regulatory inspectors in “planning a risk-based inspection relating to good data management practices” according to the PIC/S.

Also in the news

Bioprocess Insider looked at US FDA efforts to clarify CMC change reporting rules for biologic drug manufacturers.

US biotechnology giant Amgen has plants to construct a new $365m product advanced assembly and packaging facility near Columbus, Ohio. Ream more at Pharmaceutical-Technology.

The Covid-19 pandemic has had a profound impact on the vaccine industry and the wider biopharmaceutical sector according to a report by STAT.

Global life sciences and technology companies have announced the launch of the Securing America’s Medicines and Supply (SAMS) coalition. The firms, which include Coherus Biosciences, say the aim is to secure access to biopharmaceutical in the US.

Pharmatech covered US Government efforts to encourage local biopharmaceutical manufacturing to ensure the continued availability of medicines.

CDMO trends

Some developments of note in the contracting sector:

Metrics Contract Services has invested in additional production capacity to expand its drug delivery and formulation offering.

Piramal Enterprises has announced a desire to buy additional capacity, including a possible re-entry into domestic formulations. Read more at MoneyControl.

Rentschler says it is in the process of expanding antibody production capacity with new bioreactors at a facility in Germany. See press release.

Almac Sciences has invested £350,000 in an automated crystallisation platform to support solid form screening of polymorphs, salts and crystals in addition to crystallisation of amorphous materials.

Waters has expanded its collaboration with Singapore’s Agency for Science, Technology and Research (A*STAR). The organisations are working together to use analytics to improve the safety, accuracy, and speed of biologics manufacturing.