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Manufacturing, Packaging & Logistics In-Depth Focus 2020
Included in this in-depth focus are articles examining the importance of child-resistant medicinal packaging and analysing whether continuous processing is the future for pharma.
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European Pharmaceutical Review Issue 2 2020
This issue focuses on the regulatory challenges associated with increased ventilator demand during COVID-19, as well as articles investigating the use of LC-MS for protein characterisation, improving efficiency with continuous processing and the risks posed by cleanroom contaminants. Other features discuss the continual evolution of solid dosage forms and the…
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Article: Pharma Analysis & QC – Analytix Reporter special edition
Biologics continue to be a major modality in the pharmaceutical pipeline. New and unique LC-MS tools will become available for use from discovery through QC.
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MHRA issues Medicines Defect Information alert for levofloxacin tablets
Teva has informed the MHRA that the GTIN number found on a batch of levofloxacin tablets is incorrect, prompting the Medicines Defect Information alert.
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Dr Reddy’s recalls four lots of Phytonadione injectable emulsion in US
The FDA has announced that Dr Reddy's is recalling Phytonadione injectable emulsion because of complaints due to ampules breaking and shattering.
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MHRA issues Class 4 Medicines Defect Information for paracetamol
A barcode for paracetamol 250mg/5ml oral suspension displays the wrong strength when scanned, prompting the MHRA to announce the defect information.
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Jefferies announces support for new pre-filled syringe packaging solution
A private-public consortium to develop pre-filled syringe packaging has been backed by Jefferies, including a seed capital commitment of at least $10 million.
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Novartis recalls Sandimmune and Neoral over risk of poisoning
The company is recalling 100mg blister packages of both Sandimmune and Neoral due to their packaging not being child-resistant, a fault that could result in infants being poisoned.
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FDA approves label update to sodium glucose co-transporter-2 (SGLT2) inhibitors
Safety updates to labels of SGLT2 inhibitors will recommend temporary discontinuation of these medications before scheduled surgery, says the FDA.
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MHRA issues alerts over defects in Patient Information Leaflets
The MHRA has issued two alerts, one for incorrect maximum daily dosage of Ibuprofen 400mg and a second for missing safety information about Oxylan Prolonged-release tablets.
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American Health Packaging voluntarily recalls ranitidine tablets
Ranitidine tablets have been recalled due to the possibility of the products containing unacceptable levels of NDMA.
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FMD alert issued for diamorphine hydrochloride lyophilisate for solution by MHRA
A defect in the 2D matrix for the expiration date of diamorphine hydrochloride lyophilisate for solution has been announced by the MHRA.
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India to hold pharma companies responsible for drug quality after reforms
Amendments to regulations in India will make pharmaceutical companies accountable for the quality and safety of medicines, alongside manufacturers.
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Experts highlight importance of reducing pharma packaging waste
At a recent event, pharmaceutical packaging experts discussed strategies to reduce waste and protect the bottom line.
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The role of ELSIE in evolving current thinking on extractables and leachables
Extractables and Leachables Safety Information Exchange (ELSIE) has been the most influential industry group in developing guidelines for extractables and leachables. In the wake of the ICH convening a new group to develop a concept paper and business plan on their Q3E Impurity Guideline, Dave Elder discusses the strides that…
