Auxiliary Element Impurity Database Enterprise Alliance: Reduce the burden of ICH Q3D detection

A growing number of drugmakers have agreed to bring together their perceptions of the risks of accessories element impurities to help develop a central database to more easily and quickly implement the risk assessment required by the ICH Q3D Element Impurity Guidelines.
a November 10 meeting of the Society for Drug Quality Research (PQRI) on the implementation of ICH Q3D, Laurence Harris, Pfizer's Director of Global GMP Analysis, introduced the latest developments in the accessories impurity database and praised the benefits of the database.
ICH Q3D guidelines set a maximum daily allowable exposure (PDE) for 24 elements and call on drugmakers to assess the risk of introducing elemental impurities in finished preparations such as accessories, production equipment, API and container sealing systems.
guidelines came into effect for all newly approved drugs in June 2016 and for all used drugs in January 2018.
according to ICH Q3D guidelines, the information and data used in risk assessments are available from a wide range of sources, including prior knowledge, published literature, data from similar processes, supplier information, drug composition testing, and drug testing.
PQRI has held its first ICH Q3D Elemental Impurity Requirements Conference in 2017, meetings in this area have been held for four consecutive years to discuss ICH Q3D's global implementation, enterprise and regulatory challenges and responses.
first day of this year's session, regulators described the progress and shortcomings in the evaluation of elemental impurities currently seen in the review.
the Lhasa database, which helps companies conduct risk assessments by identifying accessories and their elemental impurity levels that are already used in listing applications.
Harris says the database eliminates the need for drugmakers to conduct their own analytical tests, "if six or seven companies have tested for lead levels in 15 different sources of glycol, why should I do it again?" "The Lhasa database was established in 2015 and launched in 2016, initially with eight enterprise members, sharing information about element impurities in accessories that have been detected.
now has 13 members in the database alliance, including AbbVie, Ache Laboratorios Farmaceuticos, AstraZeneca, Borang, Baxter, Celgene, GlaxoSmithKline, Novartis, Pfizer, Polpharma, Sanofi Pasteur, Takeda Pharmaceuticals, and UCB Biopharma.
member companies of the Alliance contribute their results from internal analysis of the level of element impurities in the accessories in exchange for access to the database.
As the number of members increases, the database has grown from 800 analytical studies and 26,723 element impurity determinations for 200 accessories initially started to 40,574 elemental impurities assays for 299 accessories.
In addition to being available to alliance members, the database is also available to regulators to clarify why certain accessories are at a relatively low risk relative to other accessories in a particular formulation at a given daily intake.
database also includes samples of various accessories from a range of suppliers.
data-driven mitigation of detection burden Harris says the database allows businesses to quickly complete risk assessments "in less than ten minutes" to identify elemental impurities for specific accessories.
ICH Q3D was first released in 2014, there was little data on elemental impurities, and accessories "were considered a significant risk," says Harris.
" mined accessories (e.g., talcum powder) are considered high risk, while those that are not synthesized with metal catalysts are considered low risk.
but a study published in 2015 refutes these assumptions.
study, conducted by the U.S. FDA and the International Association of Pharmaceutical Supplements, assessed the risk of 24 elemental impurities in 205 samples, performed 4,900 tests, and found that the risk of accessories was lower than originally expected.
the study was published, the industry agreed that a more "science-driven" approach was needed to assess the risks of accessories.
also recognized the need to "save time and reduce detection for ICH Q3D risk assessments."
"Harris said, "The purpose of the Lhasa Database Alliance initiative is that we will be able to build a database that we can use as a data driver and hopefully generate a resource that reduces the need for continuous accessories detection that we don't think is necessary."
vendor in the Database database is obscured and only the names of the accessories are listed.
database is updated annually.
Harris said the database was designed to supplement the data in published supplemental literature and was the "largest known collection" of such data at present.
he said that at Pfizer, the database was used to conduct product risk assessments to ensure that palladium remained below the PDE threshold.
Pfizer uses palladium in APIs and company-made catalysts.
, said the alliance welcomes new members and "we want to continue to develop this database."
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