In this week’s news, EU wants more feedback on GMP rejig, CDMOs need digital QC tech, US pledges billions for coronavirus vaccine and more…
EU opens second consultation on proposed GMP revisions
The EU wants more feedback on its plan to add quality risk management (QRM) principles to GMP guidelines.
The European Commission, the EMA, the PIC/S and the WHO launched the second round of consultations last week. It said that although QRM is not mentioned explicitly in the proposed revision, the principle applies to the whole document.
It wrote, “Annex 1 was first published in 1971, to ensure sterility of medicinal products placed on the market for the benefits of patients.
Since then it has undergone a number of targeted updates but, until now it has not undergone a full review. This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow.”
The first consultation period – which ran from 2017 to 2018 – attracted input from 140 drug companies, academics and other stakeholders.
In addition to QRM, the proposed revision covers limits on microbial contamination during the qualification process. It also touches on differences between EU and US good manufacturing practices (GMP) expectations.
Lack of digital QC tech in the CDMO space a risk says expert
CDMO sector use of digital tech lags behind other industries says an expert who argues such systems could make medicines safer.
Pharma’s growing reliance on outsourced manufacturing combined with the underuse of digital technology in the CDMO space makes it harder to assess product quality according to Cathal Strain President, Neo PLM.
Writing in Pharmamanufacturing Strain said, “Pharma companies and CMOs continue to rely on disjointed, document-based processes rather than integrated digital systems to manage product knowledge and manufacturing.”
Instead Strain suggests that greater use of modern digital technologies in the CDMO space would facilitate more efficient tech transfer, greater uniformity and ultimately safer medicines.
US FDA sets date for next round of MDUFA talks
The US FDA will hold a public meeting on Medical Device User Fee Amendments (MDUFA V) next month.
The agency said it “invites public comment on the medical device user fee program and suggestions regarding the commitments FDA should propose for the next reauthorized program.”
The legislation – the current version of which expires in 2022 – sets out how much medical device manufacturers must pay FDA reviews.
It also determines agency review processes, including target action dates.
Also in the news
The US Government has earmarked $8.3 bn to fight the coronavirus outbreak. According to Reuters $3 billion will be spent on vaccine development.
Pharmamanufacturing looked at the use of digital technologies in pharmaceutical outsourcing.
The cell and gene therapy sector needs more skilled staff according to Texas A&M. The organisation told Bioprocess Insider ex-military personnel make ideal candidates.
Florida Senator Marco Rubio wants to use loans to help pharmaceutical companies construct facilities to manufacture active pharmaceutical ingredients US. His comments follow growing concerns that the coronavirus outbreak will impact API supplies. Read more at Insidehealthpolicy.
The US FDA’s decision to convert certain NDAs to BLAs will impact compounding pharmacies according to RAPS.
STAT reported that industry interest in cell and gene therapies continues to increase.
Some developments of note in the CDMO space.
Thermo Fisher Scientific looks set to buy Qiagen. The combination would expand Thermo’s diagnostics business.
Demand for CDMOs with capacity to make oral solid dosage forms continues to increase according to a ContractPharma report.
BioDuro has launched antibody and cell therapy discovery services. See press release.
STCube has hired Samsung biologics to make a candidate anti-cancer monoclonal antibody. The drug targets a new mechanism and may be more effective than current therapies according to STCube.