In this week’s news, FDA mulls plant rating system, EMA finds potential NDMA sources, EU chats drugs with China and more…
US FDA mulls quality rating system for manufacturing plants
The US FDA says a rating system for pharmaceutical manufacturing plants would better inform patients and payers.
Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research outlined plans for a facility rating system in a blog post this week.
She suggested one benefit would be to let patients, drug distributors, hospitals, and pharmacies choose suppliers that are less likely to encounter quality problems that would disrupt supply lines.
“Manufacturers with very high reliability usually have what is called a mature quality management system. However, purchasers currently are not able to readily identify those manufacturers.
“Unfortunately, incentives today are not high enough for many manufacturers to establish mature quality management capabilities.
“As a result, drug manufacturers are more likely to keep costs down by minimising investments in manufacturing quality, leading to quality issues that can trigger supply disruptions and shortages of needed medications.”
The idea of a quality system raised a few industry eyebrows. See RAPS for more details.
EMA suggests blister packs potential source of NDMA in heartburn meds
The EMA has included blister packs on a list of potential sources of the carcinogenic contaminant NDMA recently found in some heartburn drugs.
The Agency issues the list of eight potential sources in an updated version of its Q&A document on the subject last week.
According to the EMA the NDMA could be present as a result of sodium nitrite being used in production, contaminated APIs, solvents used during manufacture, cross contamination and degradation of starting materials.
The Agency also believes certain packaging materials could be the problem.
“Nitrosamine contamination has been observed by one MAH in a finished product stored in blister.
“The MAH has hypothesised that the lidding foil containing nitrocellulose printing primer may react with amines in printing ink to generate nitrosamines, which would be transferred to the product under certain packaging process conditions.”
EMA in talks with Chinese regulators
In other news, the EMA met with Chinese regulators to discuss GMP, API quality and environmental contamination.
According to a press release the meeting took place on October 25.
The EMA said “Discussions were also held around establishing a common training curriculum focused on GMP and GCP standards, in cooperation with other international partners and the WHO.
“In addition, EMA introduced the Chinese delegation to EMA’s role and activities in areas like inspection coordination, the evaluation and authorisation of medicines, and safety monitoring.
A joint EU-China consultation and cooperation mechanism was set up in 2010 to foster information exchange on pharmaceuticals, medical devices, cosmetics and regulatory science.
Also in the news
Bioprocess Online complied a great selection of trends to watch in China’s fast-growing biopharmaceutical manufacturing sector. Regulatory reforms and the country’s CDMO sector are among the topics discussed.
Seeking Alpha covered the EMA’s approval of Bluebird’s revised manufacturing method for its thalassemia gene therapy Zynteglo. They worked with CDMO apceth Biopharma.
RAPS looked at a survey suggesting that the pharmaceutical industry is doing better at complying with evolving track & trace legislation.
Some development of note in the CDMO sector:
Cytovance Biologics has upped plasmid DNA production capacity citing growing demand from gene therapy developers.
Taiwan-based CDMO Bora has opened its first North American office.
Sonnet Biotherapeutics has hired Abzena to make its cytokine derived drug candidate for clinical trials.