In this week’s news, India reviews risk system for devices, EDQM to update API certificates system and more…

EDQM plans API certificate revamp and calls for input

The European Directorate for the Quality of Medicines & HealthCare (EDQM) plans to revamp the system it uses to certify drug APIs comply with the European Pharmacopoeia.

The EDQM said it intends to redesign its “certificates of suitability” to better meet the needs of drug makers and regulatory authorities.

According to the Strasbourg-based Council of Europe directorate the idea is to focus on the provision of relevant information on active substances.

The EDQM asked drug firms, CDMOs and other interested parties to provide feedback via an online form.

USP proposes chapter on nitrosamine detection

The United States Pharmacopoeia (USP) has put together nitrosamine testing methods to help drug and API firms test for the carcinogenic impurity.

The USP says the new United States Pharmacopeia—National Formulary general chapter provides guidance on assessing materials for nitrosamine.

It also sets out control strategies for the impurity, the presence of which in some angiotensin II receptor blockers and ranitidine and metformin has been the subject of concern in recent years.

India proposes risk system for devices and diagnostics

India wants to classify devices and in vitro diagnostics according to a new risk-based system.

According to the CDSCO the idea is to adopt a similar regulatory framework for medical devices and diagnostic products sold in the country it uses for pharmaceuticals.

The proposed guidelines – here for devices and here for diagnostics – would classify products in accordance with four risk categories, based on a number of criteria.

ETHealthworld spoke to Sunil Khurana, CEO & Managing Director, BPL Medical Technologies about the risk-based classification plan earlier this year.

USP proposes revisions to chapters on plastics in drug and API production

The USP has revised drafts of the two chapters on plastic materials used in pharmaceutical manufacturing.

The tweaked chapters – <665> and <1665> discuss the selection and qualification of plastic components and systems used to manufacture active pharmaceutical ingredients (APIs) and biopharmaceuticals.

The draft changes can be view here.

Also in the news

The US FDA has issued a set of vaccine safeguards in response to concerns the agency is under pressure to rush approval of a SARS-CoV-2 vaccine in time for the presidential election.

Biopharmadive took a look at CEO and employee pay in the biotechnology sector.

AstraZeneca has put trials of its candidate coronavirus vaccine on hold after an adverse event involving one participant.

A study in Nature assessed the viability of using Phase 0 micro dosing studies in drug development.

GMP Academy set out what drug firms and CDMOs should expect from formal warning letters issued by the US FDA.

CDMO tends

Some developments of note in the contracting space:

Catalent will invest $130m to expand capacity at its gene therapy facility in Harmans, Maryland.

The UK Vaccine Manufacturing Innovation Centre (VMIC) will help Oxford Biomedica set up additional manufacturing suites for AstraZeneca’s candidate Covid-19 vaccine. See full story here.

Lonza will use automation to scale-up production of customers’ cell therapy products. The Swiss CDMO told Bioprocess Insider about its Cocoon manufacturing system.

Samsung Bioepis has called on governments and industry to ensure the security of manufacturing resources and supply chain structures.