EDQM issues guidance to remind API suppliers of responsibilities

The EDQM has issued guidelines to remind API manufacturers of their responsibilities to the drug firms that use their products.

According to the organisation, “In the recent years, and in particular during the issue related to nitrosamine contamination of drug substances, the EDQM as well as its international partners have noticed that Certificates of Suitability (CEP) Holders may often lack knowledge and awareness regarding the extent of their various responsibilities towards their customers.”

A Certification of Suitability (CEP) certifies drug ingredients are made in compliance with rules in the European Pharmacopoeia (EP). API firms that have CEPs must ensure their manufacturing practices are compliant. 

They are also required to provide customers with all information sufficient “to enable them to fulfil their respective legal responsibilities.”

The guideline is available here.

 

GAO urges US FDA overseas inspection revamp

The US FDA should take steps to improve its overseas drug and API facility inspection programmes each year, according to the US Government Accountability Office (GAO).

The GAO made the suggestion last week, writing that the FDA should set up a pilot programme for unannounced inspections, make use of independent translators during site visits and revamp its inspector recruitment practices.

On the latter point, the GAO said that “Maintaining its investigator workforce to carry out foreign inspections has been a persistent challenge for FDA”, but added that recent agency initiatives have shown promise.

 

EMA issues new nitrosamine testing guideline

The EMA has issued advice to help API firms identify and control the risks of nitrosamines.

The document includes advice on testing for N-nitrosodipropylamine (NDPA). It also provides clarity on assessing the risk of multiple nitrosamines in drug substances. 

 

Also in the news

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has published its 2022 guidance agenda. Read it here.

Staff with biotech manufacturing skills are in short supply, according to a report in STAT.

The Pink Sheet shared details of efforts the biopharmaceutical sector has made to maintain access to raw materials at the height of the COVID-19 pandemic.

Endpoints looked at US entrepreneur Mark Cuban’s plan to set up a generic drug company.

Eli Lilly has announced plans to invest $1 billion in a new manufacturing facility in North Carolina.

DCAT made predictions about potential blockbuster drugs set to be launched this year.

Andelyn calls for regulatory clarity in the cell and gene sector. Read more here.

 

CDMO trends

Some developments of note in the contracting sector:

PCI Pharma Services has added automated sterile fill-finish machines to its facilities in San Diego and Melbourne. The CDMO cited the acquisition of Lyophilization Services of New England as the impetus for the investment.

Recipharm has acquired Portuguese CDMO GenIbet, a specialist in the manufacture of biological clinical trial material, viral vectors and RNA.

Coriolis Pharma has opened a new ATMP development facility close to its headquarters in Martinsried, Germany. 

CordenPharma has bought three manufacturing facilities from Vifor Pharma. 

Apnar Pharma has acquired East Windsor, NJ based Aurex Laboratories for an undisclosed amount.