In this week’s news, US FDA sets up quality pilot for US drug and API plants, Rx-360 expects pharma to embrace remote audits and more…

US FDA rolls out quality programme for US-made drugs and API

The US FDA has launched quality management programs for domestically produced drugs and APIs.

The programmes – details of which were posted in the US Federal Register (here and here) – are designed to gather information that could give US based manufacturers an advantage of foreign rivals the FDA said.

“The aim is to gain insight from third-party assessments of a manufacturer’s quality management system to inform future development of an FDA rating system to characterize quality management maturity (QMM).

“Such a rating system would allow a cross-sectional comparison of manufacturers. Manufacturers that choose to disclose their facility ratings could benefit from a competitive advantage, as knowledge of QMM ratings would enable health systems and other purchasers and payers of medications to differentiate among drug manufacturers.”

The FDA invited companies interested in taking part in the pilot programmes to contact it and provide details of their manufacturing facilities.

The COVID-19 pandemic has increased calls for the US to reduce its reliance on imported medicines over fears of supply chain disruption.

UK to expand addiction warnings on opioid pain med packs

The UK MHRA says opioids sold in the UK must feature additional safety warning on their labels.

The regulator said the idea is to ensure that users of these potent pain medications are aware of the potential addiction risk.

It added that, in addition to the updated packaging warning, healthcare professionals have been asked to discuss these warnings with any patient taking or planning to take an opioid-containing medicine.

MHRA Director of Vigilance and Risk Management of Medicines, Sarah Branch said,” Last year, we announced that opioid-containing medicine packaging must carry warnings.

“Now, we are strengthening those warnings to ensure that opioid medicines are supplied with consistent information on how to manage the risk of addiction,” she added.

Remote supplier audits will increase says supply chain group

Remote supplier audits may take longer than expected at first but the benefits are clear according to industry supply chain consortium, Rx-360.

The organisation made the claim in a new best practices guide, explaining that initially such assessments may take longer to execute than traditional site visits.

However, despite this, Rx-360 sees value in remote assessments. It wrote “Remote auditing during the coronavirus pandemic of 2019 and 2020 has grown in its utility within the pharmaceutical industry.

“Being able to understand the growing bandwidth issue on both the pharmaceutical supplier side and the manufacturer side will position remote auditing to continue its growth and utilization for the long term.”

Also in the news

The Association for Accessible Medicines (AAM) has published a whitepaper setting out its position on testing for nitrosamines, potentially carcinogenic compounds present in some drugs.

Politico looked at the impact the coronavirus pandemic may have on drug manufacturing in Europe.

The New York Times covered the likely impact the development of SARS-CoV-2 vaccines will have on the ongoing drug pricing debate in the US.

Bloomberg says manufacturing issue mean Russia will miss its Covid-19 vaccine production target.

Merck & Co announced plans to build a new facility to make the bladder cancer treatment Tice BCG in the US. The firm – which unexpectedly became the only manufacturer of BCG for patients in many countries around the world in 2012 – said demand had outpaced capacity.

Reuters reports Indian drug and API contractor Dr Reddy’s Laboratories has been hit by a cyber-attack.

CDMO tends

Some developments of note in the contracting sector:

Thermo Fisher Scientific says it plans to expand capacity at its manufacturing Singapore facility.

Sharp says it will invest $10m to add capacity for biologic drug and injectable packaging at its facilities in Allentown in the US and Hamont-Achel in Belgium.

Cambrex has expanded its facility in Edinburgh, Scotland, increasing capacity for solid dosage form manufacturing.