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A systematic approach for the evaluation, validation, and implementation of automated colony counting systems
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Release Date - 24th March 2022
  bioburden     data integrity     environmental monitoring     Rapid Micro     rapid microbiological methods  
Abstract
This paper describes a systematic approach to the evaluation, equipment qualification, and deployment of automated colony counting systems, which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits.
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Alternative adventitious agent detection methods in biopharmaceuticals: A proposal for a structured best practice approach for their evaluation, validation, and implementation
315.52 KB 2 file(s)
Release Date - 29th June 2022
  Adventitious virus and mycoplasma     ARMM     Rapid Micro     rapid microbiological methods  
Abstract
This paper addresses the need for a systematic and best practice approach to the evaluation, validation and implementation of these methods related to adventitious agents testing to support the adoption of alternative adventitious agent testing (AAT) methods. A nine-step framework and common language are described which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMMs and alternative AATs.
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Alternative and rapid micro methods (ARMM): A framework for the evaluation, validation and implementation of alternative and rapid microbiological testing methods
290.96 KB 1 file(s)
Release Date - 21st July 2020
Abstract
There are now available to the biopharmaceutical industry several alternative and rapid microbiological methods (ARMMs) for the detection and enumeration of microorganisms during testing. Regulatory authorities are encouraging the biopharmaceutical industry to adopt innovative technologies. Together these methods will lead to improved monitoring and assurance of control of biopharmaceutical processes and manufacturing environments, as well as shortened cycle times in the supply chain. This paper addresses the need for a systematic and best practice approach to the evaluation, validation and deployment of these methods. The absence of such best practice has hindered the adoption of ARMMs, resulting in slow adoption. A nine-step framework and common language is described which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMMs.
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Alternative and rapid micro methods (ARMM): Practical applications of bio-fluorescent particle counting in Environmental Monitoring investigations
0.00 KB 0 file(s)
Release Date - 6th December 2019
Abstract
Investigations into environmental monitoring (EM) excursions can be prolonged and do not always result in clear root causes or CAPAs. This paper outlines how bio-fluorescent particle counting (BFPC) can be used in investigations to eliminate the inherent delays of culture-based methods. The application for investigations supplements routine EM; acting as a risk reduction tool enabling real-time detection of viable microorganisms in air samples − supporting root cause analysis and remedial actions. The paper includes guidance on how to use the technology, a real case study involving a mold excursion, and examples of business benefits achieved by various companies.
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Application of first principles primary drying model to lyophilization process design and transfer: case studies from the industry
0.00 KB 0 file(s)
Release Date - 9th March 2021
Abstract
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.
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Attribute matrix on PAT for in-line monitoring and real-time release
0.00 KB 0 file(s)
Release Date - 26th October 2021
  ILM and RTR     ILM and RTR in DP     PAT  
Abstract
A BioPhorum member only attribute matrix consisting of analysis of the current and desired state of PAT for ILM/RTR
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BioPhorum deliverables mid-year report 2021
6.61 MB 1 file(s)
Release Date - 2nd July 2021
Abstract
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Container closure (CCI): Dye ingress methods for container-closure integrity testing: An industry position paper
0.00 KB 0 file(s)
Release Date - 15th September 2018
Abstract
The release of the expanded USP in 2016 cast doubt over the validity of so-called probabilistic analytical methods, including one the biopharmaceutical industry’s most universal tests – the dye ingress method for container closure integrity With the dye ingress method ubiquitously used without issue for decades, this paper highlights the continued value and applicability of this and other probabilistic analytical tests. In addition, this paper also describes how any method, whether probabilistic or deterministic, stands or falls on the quality of its development and validation, and not necessarily on the properties of the test itself. The most important factor is to apply a test method is not how it is labelled, but lies in its development, qualification and whether it meets the need for which it is designed.
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Container closure integrity (CCI): Container closure integrity control versus integrity testing during routine manufacturing
0.00 KB 1 file(s)
Release Date - 7th June 2015
Abstract
In 2014 uncertainty around regulation for container closure and integrity testing (CCIT) fed a perceptible shift in mindset across the industry, causing some concern amongst many subject matter experts in biological manufacturers. Their concern was that gaps in guidance was enabling skewed expectations such that they would promote 100% CCIT for the release of drug product batches. This paper addresses this concern by re-stating the principles of CCI, qualification, process control and in-process testing to establish the framework within all effective container closure integrity programs. It concludes that performing 100% CCIT does not provide certainty that a process is well controlled and introduces an additional step that is not always necessary or suitable for the high processing speeds in the industry.
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Container closure integrity (CCI): Response to the publication of USP<1207>
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Release Date - 19th January 2017
Abstract
USP published its revised and expanded guidance, USP, in 2016 ostensibly asking as many questions as it answered. Specifically, USP implies ’probabilistic’ tests such as the ubiquitous dye ingress method are inferior and proposes a preference for so-called deterministic tests. The added assertions that deterministic methods can achieve high levels of sensitivity and accuracy do not reflect the ‘real world’ experience of the industry’s CCI experts whose work with the newer methods highlight a range of improvements that must be addressed before such claims can feature in guidance. This paper makes the distinction that any method – probabilistic or deterministic – when properly validated may be regarded as acceptable, with no one method type worthy of a preferred status
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Container Closure Integrity: How to solve the CCI puzzle
0.00 KB 0 file(s)
Release Date - 30th June 2020
Abstract
Finish Biopharmaceutical Drug Products for a Modern Age is a formulation/fill-finish eBook containing two articles. One of these articles, written by Scott Ewan BioPhorum Fill Finish facilitator, brings together details on activity in the Container Closure Integrity workstream.
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Container Closure Integrity: User requirements specification (URS) for optimized container closure integrity testing equipment
181.37 KB 1 file(s)
Release Date - 18th November 2020
  CCIT     container closure integrity  
Abstract
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.
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Continued process verification (CPV) and the validation of informatics systems
0.00 KB 1 file(s)
Release Date - 21st November 2018
  Continued Process Verification     CPV     Drug Product     ILM and RTR     in-line monitoring     Operations     Quality     Real-time release  
Abstract
Continued process verification (CPV) provides ongoing verification of the performance of a manufacturing process and as such entails the processing of large amounts of data. This paper draws on the experiences of multiple biopharmaceutical manufacturing companies in validating the informatics components of their CPV programs. It sheds light on common issues and provides recommendations and best practices. Computer systems validation is relevant across the lifecycle of a CPV informatics solution. As such the papers scope includes the initial and ongoing activities and deliverables to determine that the solution meets its intended uses and other requirements, for example, data integrity and performance requirements. 
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Covid-19: How industry is using technology during the covid-19 pandemic
4.75 MB 1 file(s)
Release Date - 1st September 2020
Abstract
This article looks at the role of technology in the workplace and specifically how the Senior BioPhorum Connect group is addressing issues such as the use of remote working technologies, cyber security and digitizing the cGMP space.
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Datamining to determine the influence of fluid properties on the integrity test values
0.00 KB 0 file(s)
Release Date - 20th July 2020
Abstract
Eudralex volume 4, Annex 1, the EU GMP for sterile products, requires that ″The integrity of the sterilised filter should be verified before use · · ·″ (1). Implicit in this requirement for a pre-use, post-sterilization integrity test (PUPSIT) is the rationale that the sterilizing filter could sustain damage during sterilization or use (i.e. subsequent to any pre-use test conducted prior to sterilization), causing a defect which would not be detected by the post-use integrity test. That is, that such a defect could be ″masked″ during filtration. To assess whether a filter defect could be masked by partial filter plugging the Consortium evaluated the impact of bacterial retention testing on the bubble point (BP) of the test filters. The paper concludes that filtration processes producing bubble point changes sufficient to present a risk of masking defects are not common, and detectable during the routine BCT. Thus the BP ratios observed during routine bacterial retention testing is one means to assess the potential of a given filtration process for masking of defects and can be considered when determining whether a PUPSIT should be implemented.
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Elastomer stoppers: Improving quality standards for elastomer stoppers In parenteral drug manufacturing
0.00 KB 0 file(s)
Release Date - 30th April 2018
Abstract
Stoppers are a known source of particulate contamination. This is, in part, due to various physical and technological limitations inherent to the stopper manufacturing process. As a quantitative control measure, stopper manufacturers perform a battery of release tests to determine lot acceptability against established quality standards. Among the universally required release tests is particulate load of a representative sample. Elastomer stoppers are commonly tested under guidance provided through ISO 8871-3. During BioPhorum engagement with several stopper suppliers, it became apparent that multiple elements of this particle count method — including, but not limited to, equipment, environment, and particle classification — varied across the different suppliers. Consequently, the BioPhorum Stopper Quality team determined a need to undertake a comparative analysis of the test methods and constituent variables that are currently utilized by stopper manufacturers. This paper is intended to highlight testing inconsistencies and drive the collaborative development of a more sensitive, harmonized particle count method.
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Environmental Monitoring (EM): A harmonized risk-based approach to selecting monitoring points and defining monitoring plans
7.87 MB 2 file(s)
Release Date - 10th November 2020
  environmental monitoring     environmental monitoring in drug product (EMinDP)  
Abstract
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.
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Environmental monitoring (EM): Continuous microbiological EM for process understanding and reduced interventions in aseptic manufacturing
0.00 KB 0 file(s)
Release Date - 1st March 2019
Abstract
This paper provides recommendations for quality oversight, manufacturing operations, and industry perspective of regulatory expectations to enable aseptic facilities to move toward real-time and continuous microbiological environmental monitoring, thereby reducing interventions and future replacement of Grade A settle plates and nonremote active air sampling. The replacement of traditional monitoring with biofluorescent particle-counting systems provides an improvement in process understanding and product safety and reduces operator manipulations, assuring product quality and real-time process verification. The future state pharmaceutical technology roadmaps include gloveless isolators with real-time and continuous monitoring for aseptic manufacturing.
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Environmental monitoring (EM): Risk assessment template
0.00 KB 1 file(s)
Release Date - 28th February 2019
Abstract
This Excel spreadsheet tool compliments the guidance document 'Environmental monitoring: harmonized risk-based approach to selecting monitoring points and defining monitoring plans'. This allows the user to assess a room against six factors, the amenability of equipment and surfaces to cleaning and sanitization, personnel presence and flow, material flow, proximity to open product or exposed direct product contact material, the need for interventions/operations and their complexity, frequency of intervention and score them
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Formulation: An intercompany perspective on biopharmaceutical drug product robustness studies
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Release Date - 1st February 2018
  Control strategies     CQA     Design space     Development     Drug product robustness     Formulation     Quality by design (QBD)  
Abstract
To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Workstream conducted an intercompany collaboration exercise, which included a benchmarking survey and extensive group discussions around the scope, design, and execution of robustness studies. The results of this industry collaboration revealed several key common themes: (1) overall DP robustness is defined by both the formulation and the manufacturing process robustness; (2) robustness integrates the principles of quality by design (QbD); (3) DP robustness is an important factor in setting critical quality attribute control strategies and commercial specifications; (4) most companies employ robustness studies, along with prior knowledge, risk assessments, and statistics, to develop the DP design space; (5) studies are tailored to commercial development needs and the practices of each company. Three case studies further illustrate how a robustness study design for a biopharmaceutical DP balances experimental complexity, statistical power, scientific understanding, and risk assessment to provide the desired product and process knowledge. The team discusses identified industry challenges with regard to biopharmaceutical DP robustness and presents some recommendations for best practices.
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Human performance (HuP): A new measurement approach to better drive, safety, quality, reliability in biopharmaceuticals
0.00 KB 1 file(s)
Release Date - 8th August 2018
  human performance     KPIs     Measurement     Operations     Quality  
Abstract
One of the dilemmas companies face when driving down failures and near misses to 'zero' is what to measure. Conventional approaches often fail to support ambitious 'zero' performance levels and can discourage the right type of debates and discussions. This guide from the Human Performance (HuP) team explains how biopharma operations can understand and measure performance in the most meaningful way and how to capture risks and enable sustainable learning and improvement through the 'Family II' mindset. Piloted by four companies the guide explains how to measure success rates and encourage employee reporting, how to implement such reports, and management the communication around the program to help everyone get closer to the target of zero failures.
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Human performance (HuP): Changing the performance paradigm in pharma/biotech: Integrating human performance in global organizations
0.00 KB 1 file(s)
Release Date - 28th September 2015
  deviation management     Deviations     human performance     Leadership     Operations     Quality  
Abstract
In 2015 when the BioPhorum Human Performance team started to understand how the industry could reduce error rates many were seeing a plateau of performance. Industry data showed 50% of deviations were attributable to human error and that the error rate has been constant over several years. Comparing us to other high-risk industries with unparalleled levels of reliability, such as nuclear power and aviation, the team saw that changes that could be made with the integration of HuP into our operations. This article utilizes the experience of two large, global biotech companies, at the time to illustrate the pathways to integrate HuP and the benefits realized not just in human error reduction, but also to quality, safety, compliance, and on-time delivery—the critical measures that will make or break a biotech company’s performance.
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Human performance (HuP): Guide to implementing and maintaining a leader observation and coaching program
0.00 KB 1 file(s)
Release Date - 18th October 2018
  Coaching     Deviations     human performance     Leadership     Operations     operator competence     Quality  
Abstract
A well established Human Performance program will significantly reduce failures and deviations in any biomanufacturer's operation. Critical to this is the creation of a culture where leaders partner with workers to learn about what enables success and what creates challenges. This learning is most effectively done through first-hand observation, active listening and ensuring candid discussions about systems’ issues related to risk. Written by BioPhorum’s Human Performance Workstream, this guide details how to implement and maintain a leader observation and coaching program, what such a program entails, the expected benefits, the expectations for leaders and a suggested implementation plan.
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Human performance (HuP): Lonza error prevention system (EPS) – Changing human performance in pharmaceutical operations
0.00 KB 0 file(s)
Release Date - 9th September 2016
  deviation management     human performance  
Abstract
Errors are a part of life. With human errors accounting for approximately 50% of quality incidents and related problems within the pharmaceutical industry, the need to improve human performance in manufacturing operations is obvious. The purpose of this article is to describe error-proofing ways of structuring and writing knowledge documents, procedures, batch records, as well as practices for structuring, conducting, and documenting training to assure competence. These practices are recommended for adoption to shift the current 'training for compliance' paradigm to a 'training for competence' paradigm. It will also be demonstrated that a training for competence focus achieves GMP compliance. Results at Lonza have been encouraging, with human error-related quality deviations and non-conformities reduced by more than 40% across 13 sites globally within the first two years of the implementation of its Error Prevention System.
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Human performance (HuP): Training for biotech manufacturing operator competence
0.00 KB 1 file(s)
Release Date - 26th March 2016
  deviation management     human performance     Leadership     Operations     operator competence     Training  
Abstract
For decades, the biopharmaceutical industry has trained its workforce with a ‘read and understand’ approach. This approach is outdated and ineffective at delivering effective learning and competent staff. This ‘Training for competence’ guidance enables companies to understand how their organisation compares to their peers, and to identify what ‘best in class’ looks like for operator training, and will help to identify how to implement this approach across their networks
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Isolator best practices: Benchmark and analysis
0.00 KB 0 file(s)
Release Date - 15th May 2020
Abstract
This benchmark details the current industry operating practices on gloves testing, surface disinfection and interventions in isolators. It includes the practices from 26 biopharma drug product sites from 14 member organizations. The survey has been used to share practices and consider the opportunities for joint improvement in the industry. in more detail the survey compares glove inspection both visual and automatic integrity testing, disinfection and cleaning methods as we as the use of H2O2.  Interventions, their categorization, tracking and approval, operator qualification and the handling of door seal failures.
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Isolator glove management evaluation of regulatory guidance and framework of recommendations
1.23 MB 1 file(s)
Release Date - 31st January 2020
Abstract
The loss or delay of a batch for glove failure and uncertainties of glove management are perennial concerns for aseptic filling operations. Written by a team of industry practitioners who create, justify and manage glove programs, this guide defines current best practice and the actions we can all take to reduce risk. Specifically it enables users to understand glove-related risks, facilitating deviation investigations and building confidence when presenting to inspectors. Helps users understand the rationale for supplier recommendations about glove lifecycle management. Reduces the need for users to develop their own glove lifecycle management strategies and standardizes the language for collecting data in and across companies, that will support future benchmarking and improvement.
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Line clearance benchmarking survey
0.00 KB 0 file(s)
Release Date - 26th October 2021
  secondary packaging  
Abstract
A BioPhorum member only benchmark survey identifying line clearance best practice, as part of the Secondary Packaging workstream.
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Line clearance risk assessment in secondary packaging areas
353.90 KB 1 file(s)
Release Date - 19th May 2022
  secondary packaging  
Abstract
This document describes the basis for performing a risk assessment for line clearance (LC) activities and failures. It contains a general description about the process and a template. This template is meant to support the documentation of the assessment of risks related to the LC process in secondary packaging lines handling pharmaceutical products and combination devices.
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Lyophilization: An industry perspective on the application of modeling to lyophilization process scale up and transfer
0.00 KB 0 file(s)
Release Date - 16th March 2017
Abstract
While freeze-drying modeling is well established and documented, the extent of its application to routine operations, including development and manufacture, has not yet been fully realized. A survey, conducted by BioPhorum, revealed that only a few companies use modeling for scale up and transfer. For the last year, the collaboration has been combining individual company efforts with the aim of harmonizing best practices and helping to define minimum regulatory standards. This paper outlines different applications of modeling to freeze-drying of biopharmaceutical products at commercial scale. It also signals the intent of the BioPhorum to champion a wider adoption, and realize the full potential of modeling across the industry to standardize lyophilization practices, accelerate technology transfers and optimize operational performance
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Member experiences of campaign manufacture with lyophilization processes
0.00 KB 0 file(s)
Release Date - 24th May 2022
  Lyophilization  
Abstract
The topic of campaign manufacture for lyophilization processes was discussed by the BioPhorum Lyophilization group. This member only publication is a summary of the approach taken by the major biopharmaceutical companies with experience of campaign manufacture who are members of the group.
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Operational vision: Adoption of in-line monitoring and real-time release
1.95 MB 1 file(s)
Release Date - 27th June 2022
  ILM and RTR  
Abstract
Historically, the biopharmaceutical industry has relied on traditional pharmaceutical manufacturing practices to make and release products. This publication examines the future of biopharmaceutical manufacturing by presenting the vision of fully implemented in-line monitoring (ILM) and real-time release. This aspirational vision includes full ILM, predictive analytics and advanced process controls (APC) enabling release of product in real time, with concomitant predictive and preventative alerts and resolution of process, equipment and other production issues.
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Particle classification: An industry-wide standardized methodology and risk classification tool for PC in biopharmaceutical parenteral products
0.00 KB 1 file(s)
Release Date - 5th October 2019
Abstract
All companies need to classify the risks various types of visible particles provide. This is not a simple task and without a well supported, scientific basis companies lay themselves open to regulatory challenges and sometimes have to commit to questionable controls. The proof of concept, developed by a large group of industry practitioners, allows companies to underpin their particle classification practices with a rational, risk-based approach. It will not change how companies classify visible particles, but will provide a framework to support their current classifications. The methodology assesses a range of patient risk factors, such as the route of administration, and applies a simple scoring system to calculate an overall risk score for a visible particle in a product or presentation. When challenged by regulators or internal QA teams, the methodology helps companies respond to demands to change particle classifications using an assessment of risk, which in turn may save batches from being destroyed if a classification is unnecessarily severe.
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Particle classification: Risk classification tool
0.00 KB 1 file(s)
Release Date - 4th October 2019
Abstract
This is the Excel spreadsheet based tool that compliments the guidance document titled 'An industry-wide standardized methodology and risk classification tool for particle classification in biopharmaceutical parenteral products' As such it enables users to enter product information and particle details and create a risk classification score in line with the guidance.
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Peer to peer practical guidance on remote inspections and audits
208.89 KB 1 file(s)
Release Date - 22nd January 2021
  audit     Covid-19     remote inspection     virtual inspection  
Abstract
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.
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Protocol and report for human readability study of single characters - application for biopharmaceutical vision system settings
11.25 MB 2 file(s)
Release Date - 7th September 2021
  secondary packaging  
Abstract
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.
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PUPSIT and the annex one revision
0.00 KB 0 file(s)
Release Date - 20th July 2020
Abstract
This article presents an update on the efforts of the joint PDA and BioPhorum collaboration workstreams—masking studies, historical data mining, filter manufacturing and use risk assessments and PUPSIT risk assessment and the development of a best practice guide.
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Rising to the challenge of BioPhorum's small flexible filler URS
1.31 MB 1 file(s)
Release Date - 29th September 2021
  small flexible fillers  
Abstract
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.
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Secondary Packaging: Electronic product information
992.32 KB 1 file(s)
Release Date - 26th March 2021
  digital health     electronic packaging     ePI     secondary packaging  
Abstract
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.
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Serialization – challenges and good practices in packaging operations based on experience of track and trace systems
3.34 MB 1 file(s)
Release Date - 7th September 2021
  secondary packaging     serialization  
Abstract
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
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SFQRM: Strategy roadmap for the implementation of a risk-based approach to pre-use post-sterilization integrity testing (Pupsit)
203.65 KB 1 file(s)
Release Date - 27th November 2020
Abstract
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:
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SFQRM: Test process and results of potential masking of sterilizing grade filters
0.00 KB 0 file(s)
Release Date - 20th July 2020
Abstract
This paper is one in a series of publications that are the result of the collaboration, and these should be considered together and viewed holistically in order to determine the best course of action with regard to PUPSIT. This paper examines the test process and looks at the results of potential masking of sterilizing grade filters.
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SFQRM: The use of scientific data to assess and control risks associated with sterilizing filtration
0.00 KB 0 file(s)
Release Date - 20th July 2020
Abstract
This article draws conclusions from the scientific studies, workstreams, and publications delivered by the Sterile Filtration Quality Risk Management (SFQRM) consortium formed between BioPhorum and PDA. It uses those conclusions to provide guidance to industry (sterile drug manufacturers, filter suppliers, and regulators) on the use of quality risk management principles and scientific data to prevent undetected non-integral sterilizing filters.
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SFQRM: The use of scientific data to assess and control risks associated with sterilizing filtration: a PDA and BioPhorum collaboration
0.00 KB 0 file(s)
Release Date - 10th November 2020
Abstract
It is generally recognized that post-use filter integrity testing is sufficient to detect filter failure and ensure patient safety unless there is a possibility that a filter passing the post-use test could have allowed bacterial penetration during filtration. This possibility is the phenomenon referred to as filter “flaw masking”, hypothesized to occur when, for example, a filter is damaged during sterilization such that it allows bacterial penetration, but that the damage becomes plugged during the filtration process to such an extent that it allows the filter to exhibit a passing post-use integrity test result. Two workstreams within the SFQRM consortium were designed specifically to evaluate the risk of this filter flaw masking and to understand in what conditions it might occur: Masking Studies, and Bacterial Challenge Test (BCT) Data Mining.
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Slide Deck - A Standardized Risk Assessment Tool and Harmonized Approach for Selection and Definition of Environmental Monitoring points​
3.68 MB 1 file(s)
Release Date - 27th September 2021
Abstract
The slides that support the webinar presentation 'An industry perspective on common practise in forced degradation studies of biopharmaceuticals', presented on 15 June 2021.
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Slide Deck - How to implement the human readability study of single characters
3.51 MB 1 file(s)
Release Date - 19th October 2021
Abstract
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Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products
226.04 KB 1 file(s)
Release Date - 14th December 2021
  classifying visible particles     particle classification     Visual inspection  
Abstract
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.
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Technology for visual inspection benchmarking survey
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Release Date - 26th October 2021
  Visual inspection  
Abstract
A member only benchmark examining the technology trends in visual inspection.
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URS for small flexible filler technology
0.00 KB 1 file(s)
Release Date - 26th June 2018
Abstract
As the product in company pipelines increase in number and reduce in expected patient numbers there is a need to move from large batch, high-speed lines, to agile units that can rapidly switch between products. These changes are leading to innovation and creativity from equipment suppliers, but in addition customers need more standardization and fewer proprietary systems to aid with interchangeability, reliability and unit cost reduction. To make this happen in good order users need to ask for similar capabilities, using the same language to create necessary pull to influence equipment suppliers. This URS establishes an industry benchmark of flexible filling needs and serves to streamline the acquisition and approval of new equipment by pharma company leadership. It will enable the industry to bring products to patients faster and reduced costs through use of standard components and processes. Ultimately, enabling organizations to develop small-batch capabilities in preparation for the future of personalized medicines.

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