In the news this week: US FDA outlines remote inspection plan; Korea poised for CDMO sector growth; New Zealand to modernize GMP code and EC clarifies on IVD device production rules.
US FDA sets out remote inspection plan in new guidelines
The US FDA has set out how it conducts remote inspections of drug and API manufacturing sites in guidelines issued this week.
The document makes clear “remote interactive evaluations” will be used for all agency programmes including preapproval and pre-license inspections, post-approval inspections, surveillance inspections as well as compliance inspections.
The FDA said teleconferencing, livestreaming video and screen-sharing technologies will be used, explaining that – for security reasons – it will use selected platforms and equipment to host virtual interactions, citing Microsoft Teams, Zoom for Government and Adobe Connect.
The agency added that facilities undergoing inspection must provide documentation in electronic format or make it available via screen sharing. Plants must also grant access to encrypted and password-protected files.
Korea set for CDMO boom says industry group
A Korean industry group says the drug industry’s focus on advanced therapies has prompted local companies to set up CDMOs.
According to a new report (here in Korean) by KoreaBio demand for CDMOs with production capacity for cell-based immunotherapy, gene therapy, and cell therapy is likely to increase over the next few years.
According to KoreaBIO CDMOs need to obtain “human cell management business approval” from the Ministry of Food and Drug Safety under the Act on Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals that was introduced last year.
The industry group cited recent approvals gained GC Cell and CHA Bio Lab – as well as plans outlined by Daewoong Pharmaceutical and Pharmicell – as evidence of the vitality of Korea’s contracting sector.
NZ to adopt PIC/S GMP code next month
New Zealand is set to change its GMP code with tweaks to rules on cross contamination and starting materials.
Medsafe, the country’s regulator, announced the plan this week, explaining that it will replace the current code which dates from 2009 with the version adopted by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2018.
The agency said it had received “generally positive” feedback from industry about the proposed changes. It also said that while the new code would be adopted in early May, manufacturers will have until November to bring their operations into line with the new requirements.
EC aims to clarify risk in-vitro diagnostics classifications for manufacturers
The European Commission’s Medical Device Coordination Group (MDCG) has set out how its risk-based certification system for in-vitro diagnostics will work.
According to a document published by the group, under the new In Vitro Diagnostic Regulation (IVDR) diagnostic techs will be assigned to one of four categories based on their intended purpose and their inherent risks.
Category D – high risk devices – will undergo additional checks according to the MDCG, which said the devices may need to be reviewed by an expert panel or tested by an EU reference laboratory. It added that these steps may incur additional fees.
Also in the news
The Canadian Centre for Commercialization of Regenerative Medicine (CCRM) published a blog about the need to rebuild the pharmaceutical manufacturing post Covdi-19.
Reuters covered the US Government’s decision to “pause” administration of J&J’s single-shot COVID-19 over a potential link to blood clots.
RAPS looked at the EMA finding that AstraZeneca’s COVID-19 vaccine may have a “very rare” but serious side effect of unusual blood clotting with a low blood platelet account.
RAPS also looked at several warning letters issued to CDMOs and drug firms after “virtual” inspections.
The Serum Institute of India (SII) must ship Covid-19 vaccine to global vaccine sharing facility COVAX, its co-lead Gavi has told Reuters.
Some developments of note in the contracting sector:
Mastercontrol told ContractPharma that CDMOs need to be paperless.
Pfizer’s contracting arm blogged about the perils of an insecure API supply chain.
The New York Times looked at problems encountered by Emergent Biosolutions making Covid-19 vaccines for J&J.