Steps to eradicate undetected contaminations in anaerobic testing
All biopharmaceutical manufacturers have a legal obligation to monitor the microorganisms that are found ...
Fill Finish
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Rising to the challenge of BioPhorum’s small flexible filler URS
This paper delivers a seminal example of how BioPhorum can partner with biopharmaceutical suppliers to address the needs of the industry, support new technology adoption in biopharma and facilitate positive and lasting change. BioPhorum’s Small Flexible Filler (SFF) URS allowed Groninger to build a line that would otherwise not exist, defining a strategic direction for the future of liquid fill and finish for the biopharmaceutical industry. Within two and a half years of BioPhorum publishing the SFF URS, Groninger, a German supplier to the industry, has developed a gloveless, robot-based, automated filling line that aligns with the URS and relevant current regulatory expectations.
Protocol and report for human readability study of single characters – application for biopharmaceutical vision system settings
The packaging of pharmaceutical products is regulated in most countries. Authorities expect that any printed information – such as product, use and storage data on the packaging material artwork or batch-specific data (e.g., expiration date) – is readable by the patient. Batch-specific data is commonly checked by vision systems using optical character verification. Pharmaceutical companies must be able to document traceability between what patients can read and understand, and how much of single characters can be ‘missing’ before they may be misread. While the term ‘readability’ in various regulations relates to the contrast between the background color and the text color (or to the font size), it does not consider how much that any missing parts of single characters may impact human interpretation of what is printed.
The purpose of the protocol is to use supporting data to establish how much of each single character can be missing before it is no longer perceived as the intended character. The report supplies the basis for defining acceptable character defects and supports setting up limits for vision systems to detect good/bad characters and minimize labeling errors.
Serialization – challenges and good practices in packaging operations based on experience of track and trace systems
This paper provides an overview of points to consider and good practices relating to the most challenging areas identified following an industry benchmark on the serialization of sellable units. The purpose of this benchmark was to identify common industry challenges with serialization and to broaden the knowledge of good practice, industry capabilities and to identify the quickest route to implementation and compliance with global serialization requirements. The paper also seeks to encourage dialogue between industry, regulatory agencies, and track and trace system providers, by adding the unique perspective of secondary packaging customer, summarized after several years of using such serialization systems
BioPhorum deliverables mid-year report 2021
BioPhorum is here to help you make better decisions, faster in your operations. Membership puts you and your team at the center of current debates and helps you to stand shoulder to shoulder with those moving the performance dial on challenges that need a collective voice and a global perspective to resolve. The BioPhorum Deliverables Report is a consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry...
Secondary Packaging: Electronic product information
BioPhorum has created a structure and approach to respond to the challenge of developing ePI solutions that add value to patients and healthcare providers alike highlighting the benefits and challenges of the broad range of factors surrounding the design and implementation of ePI, supporting the objective of finding a solution that can be implemented globally . The packaging perspective on ePI is simple: agree on an ePI format, and packaging functions can agree on how to apply it to product packaging. This paper looks at the opportunities and challenges and recommends the adoption and use of GS1 standards and recommendations both to meet supply chain and point of care needs and as a way to harmonize implementation of regulatory requirements.
Application of first principles primary drying model to lyophilization process design and transfer: case studies from the industry
Lyophilization modeling is well documented in academic circles but has not yet been widely adopted by pharmaceutical manufacturing companies. To facilitate wider adoption and implementation, an accessible Excel–based tool is provided, presenting several fresh examples as a practical introduction to the process of modeling the primary drying phase. Case studies are presented of the tool’s application during process development and scale up which highlight business benefits that have been realized by using the model. Written by members of the BioPhorum’s Lyophilization Workstream, this paper published in the Journal of Pharmaceutical Sciences is intended to serve as a pathway to not only share the collective knowledge on the topic but also accelerate its adoption in the industry.
Peer to peer practical guidance on remote inspections and audits
Drawing on their real-world experiences, a group of experts drawn from 28 BioPhorum member companies has provided guidance on the detailed working methods that support a successful remote inspection or audit; for example, how to manage information flows between the inspectors and the site subject matter experts’ team. With the impact of Covid-19 likely to be seen for the foreseeable future, virtual inspections may be required for some time. This guidance will help all stakeholders prepare and to avoid the potential problems of remote inspections and audits.
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.