This paper reviews and identifies gaps in existing guidelines on APS for ATMPs; outlines technical limitations and challenges; and provides recommendations on design and how some of the existing challenges may be addressed through risk-based approaches.
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The intent of this paper is to illustrate that the probabilistic nature of detection is well understood and it aims to dispel the misunderstandings associated with VI through illustrated examples and by highlighting that the probabilistic nature of inspection is recognized in multiple
regulatory guidance documents.
A BioPhorum member survey aimed to gather initial industry benchmarking data and interest in defining an industry position on visible particulate control strategy for cell and gene therapies.
This member only paper explains how 100% inspection is not the same as 100% detection of defects, how VI is probabilistic in nature, how the probabilistic nature is noted is all major regulatory guidance, and explaining how probability of detection varies with a range of product and defect categories
A BioPhorum member only survey, the goal of which is to understand what the current industry standard is for visual inspection of final drug product bag for Phase I/II autologous/allogeneic cell therapy programs.
Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products
This paper provides a framework to support investigations related to atypical or frequently occurring particles observed during VI or related to field complaints – which require detailed and systematic assessment of risk to the quality of the batch. The proposal for a standardized risk investigation methodology outlined in this paper may support such risk assessments, where the total risk related to foreign particles is assessed by considering a variety of risk factors (type, frequency, etc.) and applying a failure mode and effects analysis (FMEA) tool to calculate a total risk-based score.
A member only benchmark examining the technology trends in visual inspection.
SFQRM: Strategy roadmap for the implementation of a risk-based approach to pre-use post-sterilization integrity testing (Pupsit)
Subject matter experts from the SFQRM Consortium has prepared this strategy roadmap with suggested actions and considerations to support the implementation of an effective risk-based approach:
Container Closure Integrity: User requirements specification (URS) for optimized container closure integrity testing equipment
The paper highlights a long-term desired view of CCIT to help develop equipment that can better meet end-user requirements. It will also provide confidence that CCIT methods can effectively demonstrate container integrity, such as microbial, headspace (gas, vacuum and moisture) and product integrity. It provides a long-term goal for companies that often use multiple CCIT technologies, with varied capabilities, to support the requirements of an expanding product portfolio. The URS will help overcome the significant inefficiencies that companies face. It will also help resolve the problem that the range of deterministic CCIT methods currently available do not represent a panacea for CCIT.
Environmental Monitoring (EM): A harmonized risk-based approach to selecting monitoring points and defining monitoring plans
The purpose of an EM risk assessment (RA) is to provide information to determine how to distribute monitoring to best verify that processes are operating under control. This step-by step guidance covers the EM RA process and provides recommendations on monitoring sites and methods based on the relative probability of contamination industry guidance addresses these needs and attempts to capture best practices in a useable ‘toolkit’ format. The guide incorporates good practices from biopharmaceutical manufacturers and adheres to current regulatory guidelines.