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Meeting the challenges in serialization to win in the battle against counterfeiting

The World Health Organization (WHO) estimates that medicine counterfeiting causes one million deaths a year and that 10% of all drugs sold globally are fake. Events such as Covid-19 increase these risks by disrupting the supply chain and increasing internet purchases.  A key weapon in the battle against counterfeiting is track and trace (T&T), which is the ability to track and trace products through a supply chain – with ‘track’...

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Connecting vision systems with how the patient reads a label

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...

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BioPhorum launch new sustainability phorum

BioPhorum members have given us a clear message; to be an industry that supports sustainability is extremely important to them. With no other single organization providing ‘one voice’ for the industry, discussions have been gathering pace to launch a dedicated sustainability phorum. This will become the prime vehicle to translate high-level corporate statements and commitments into practical, on-the-ground, scalable and transferable solutions....

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How to perform aseptic process simulation for lyophilized products

Proposed 2020 revisions to EU Annex 1 around aseptic process simulation (APS) for lyophilized products have prompted extensive discussions on the need for clear best practices for the process simulation of the lyophilization unit operation.   To address these expectations, BioPhorum has written an article called A better approach to aseptic process simulation for lyophilized products, which presents a risk-based, holistic best...

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PUPSIT: identifying risks and preventive controls

Pre-use post-sterilization integrity testing (PUPSIT) continues to generate considerable debate in the industry. Committing to a PUPSIT strategy is no mean feat because, while it is recommended by regulatory bodies, it may compromise downstream sterility and it is expensive to mitigate these risks. To help clarify industry thinking, the Sterile Filtration Quality Risk Management (SFQRM) Consortium is sharing its knowledge and expertise on...

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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

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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SFQRM: The use of scientific data to assess and control risks associated with sterilizing filtration

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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Datamining to determine the influence of fluid properties on the integrity test values

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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