Last week’s round -up;
23-27 August 2021
New multi-analyte methods for evaluating migration from printing inks
The EDQM has released an inter-laboratory study, conducted in 2020, on multi-analyte methods for the determination of substances migrating from printing inks to food or food simulants. The study is part of the process in the development of guidelines related to the quality and safety of materials and articles which come into contact with food. The new analytical methods were validated by 11 control laboratories and are intended for competent authority laboratories and for private laboratories to assess the safety of food contact materials and articles. These analytical procedures detect contaminants which can pass into food from printed packaging including 6 photoinitiators, 3 related degradation products and 1 plasticiser.
EMA Reflection Paper on Statistical Methodology for Comparative Assessment of Quality Attributes
The EMA has adopted a Reflection Paper on Statistical Methodology for the Comparative Assessment of Quality Attributes in Drug Development. The reflection paper provides statistical methodology for the comparative assessment of quality attributes in the settings of pre- and post-manufacturing change, biosimilar development and generics development. The paper addresses questions related to comparison objectives, sampling strategies, sources of variability, acceptance ranges and statistical analysis approaches to conclude on the similarity of two drug products based on quality attribute data. The main objective of the guidance is to establish a framework and a common language to facilitate future discussion among stakeholders and to invite comments in relation to the issues raised. This guidance complements other available regulatory guidance on comparative data assessment of quality attributes, but it also contains more detail on how to carry out the comparison task based on empirical sample data.
FDA stands by nitrosamine risk assessment deadline
The US FDA has rejected the pharmaceutical industry’s request to extend the deadline for conducting nitrosamine risk assessments to 1st September from the original 31st March 2021 deadline. In September 2020, the FDA issued guidance on nitrosamine testing for pharmaceuticals, which required manufacturers to assess the nitrosamine impurity risks associated with all chemically synthesized APIs and all approved or marketed drug products that contain those APIs or other sources of nitrosamines by 1st March 2021. The FDA extended the deadline to 31st March due to complaints received from the industry. The industry then requested a further extension to 1st September due to the “time-consuming” and “resource-intensive” risk assessments required. The industry also expressed concern that the global supply chain may be affected due to the “magnitude of the risk assessments and subsequent confirmatory testing” resulting in drug shortages. Although the FDA has worked with manufacturers that have detected a high amount of nitrosamine contamination to mitigate drug shortages, the Administration has said that it has “not planned for additional extensions at the current time”.
SWP opinion on Diethanolamine and Coconut Oil Diethanolamine Condensate as excipients
The EMA has issued the opinion of the Safety Working Party (SWP) regarding diethanolamine and coconut oil diethanolamine condensate as excipients. There are carcinogenicity and genotoxicity concerns because diethanolamine has been shown to have carcinogenic potential in mice. The SWP’s conclusions regarding use of these excipients in medicinal products were: (1) MA holders should assess whether the use of the excipients in their products is still justified. PDEs of 53 micrograms/day and 705 micrograms/day were set for lifetime use and for use up to 12 months respectively. For the condensate, the level of contamination with diethanolamine should be identified and controlled at the PDE. (2) The possibility of formation of the nitrosamine impurity NDELA must be avoided. (3) For rinse-off medicinal products, retention factors of 0.01 and 0.1 are considered acceptable for diluted and undiluted products respectively.
The SWP’s opinion may be viewed at the following link: https://bit.ly/RealCMC-3D27gTI