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Article: Regulatory guidance in designing a CCI testing strategy
A summary of the current state of container closure integrity testing in the pharmaceutical industry.
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Packaging & Labelling
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COVID-19 vaccine supply chains: LBC’s Tom Swarbrick interviews EPR’s Victoria Rees
Junior Editor of European Pharmaceutical Review, Victoria Rees, speaks with LBC's Tom Swarbrick about the glass vials needed to contain the Oxford-AstraZeneca COVID-19 vaccine.
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Factsheet: Total Organic Carbon (TOC) back to basics
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
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Why cold chain requirements are not holding COVID-19 vaccines back
Despite the stringent storage conditions required for Pfizer and BioNTech’s COVID-19 vaccine, the need for a return to normal life has levelled the playing field for all candidate prophylactics against SARS-CoV-2.
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Pharmaceutical bottle packaging – the quest for zero defects and data integrity
This article shares the results from an evaluation of a novel thermal imaging technology that took place before the initial implementation in a Pfizer manufacturing facility. The manuscript describes the technology and reviews the extensive process used to challenge its inspection capabilities through field testing. Finally, the potential benefits of…
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Class 4 Medicines Defect: missing safety information in some Perindopril products
The MHRA reports that certain packs of Perindopril products are missing important safety information, the products are not being recalled.
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Manufacturing, Packaging & Logistics In-Depth Focus 2020
Read this in-depth focus to develop your expertise in the characterisation of pharmaceutical powder and fluid flows during continuous manufacturing and find out the benefits of adopting high-resolution, cryogenically cooled thermal imaging for bottle packaging testing.
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European Pharmaceutical Review Issue 6 2020
This issue focuses on whether our vaccine innovation capabilities will prepare us for future outbreaks, how Raman spectroscopy can be used to rapidly detect SARS-CoV-2 and the development of high-throughput glycoanalytics for biopharmaceuticals. Also included are articles on opportunities in the global API market and how to successfully identify defects…
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Consistent data matters: lessons from the pandemic and the case for accelerating IDMP adoption
As ISO IDMP data standards gradually progress to implementation in Europe, Lise Stevens asks what bearing they might have had in the context of the global COVID-19 crisis.
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Whitepaper: Tips to improve SEC for mAbs and ADCs
Practical Tips for Monomer/Aggregate and Fragment Content Monitoring of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).
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Whitepaper: Single-use systems underline the rising significance of extractables and leachables studies
Single-use systems come with their own extractables and leachables challenges. Although there are no formal guidelines yet, safety must be assessed.
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iPDF: Pharma analysis & QC interactive detailed workflow
Secure your Pharma analysis & QC - Take your journey through our small molecules and biologics analysis & QC regulatory compliant portfolio.
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EMA highlights link between hydroxychloroquine and psychiatric disorders
The EMA recommends updating the product information for chloroquine and hydroxychloroquine after confirming a link between these medicines and psychiatric disorders.
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Production of hand sanitiser – consideration and tips for manufacturers
The top considerations for hand sanitiser manufacturers in the UK are outlined in this article by Robert Bussey.
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Packaging initiative to protect COVID-19 medicines against counterfeiting launched
The AlpVision COVID-19 Initiative will provide pharma companies with access to use a crytoglyph on their medicine packaging for free.
