Rolf Simons, of 3S Simons Security Systems GmbH, explains how a multi-layer approach can help secure the products along the entire supply chain and in all aspects; micro colour-code technology can decisively contribute to the success of all these endeavours.
Rebecca Vangenechten of Siemens argues that, while the pace of change will vary from company to company, all CMOs need to have a PAT strategy in place. PAT offers immense potential for pharmaceutical manufacturing.
This article by Harriet King of Biocair International focuses on bridging the gap between the logistics provider and the cool chain, a core element in the transportation of temperature-controlled pharmaceutical product.
In this second part of this series, Dr Rick Turner and Russell Reeve of Quintiles look into the concepts of interim analysis, and at the programme level.
The future demands on the Health Service are going to be partly dictated by demographic change and partly by resources available. In this article, Dr Phil Luton of the HPA examines the POCT issues.
Laetus was founded in 1974, and is the pioneer of pharmaceutical packaging security. It all started with the barcode identification system ARGUS, which over the years became the industry standard for packaging material identification. Based on that sound know-how, Laetus developed further solutions to increase security for patients. In the 90s, we developed the first camera system in the market for blister inspection. It was followed by highly sophisticated vision systems to increase and ensure the quality and effectiveness of the products for our customers.
When counterfeiting is reported globally, pharmaceutical products receive most of the attention because peoplefearpoisoning,contamination, and medicines that don’t cure. Yet the pharmaceutical market spends less on authentication technologies as a percentage of sales than the luxury market. Why? Part of this is due to the unique way prescription drugs are distributed in the largest global market, the US, where the patient seldom sees original packaging.
The problem of counterfeit medicines was first addressed at the international level at a World Health Organization (WHO) conference in 1985. Things have come a long way from there, and much has been undertaken to combat the growing threat of fake medication. Yet, while governments and organisations are discussing the implementation of a uniform definition into their respective legislations, and guidance is being published for mass serialisation of prescription medicines, the counterfeiting ‘business’ is shifting to new markets.
Pharmaceutical packaging manufacturers increasingly agree to ‘zero fault’ supply agreements from brand owners in order to win contracts. To meet the requirements of these agreements, manufacturers have to make their quality assurance procedures more robust than ever before – a costly and time-consuming business. However, help is on hand from an unlikely source.
In multi-particulate systems the dosage of the drug substance is – in contrast to classic single-unit dosage forms like tablets – divided on a plurality of sub-units, consisting of thousands of spherical pellet particles with a diameter of typically 100 – 2000 ?m. Although their manufacture and design is more complex in comparison to classic single-unit dosage forms, multi-particulate dosage forms offer a magnitude of different interesting options and advantages to accomplish unique product characteristics and in particular specific drug release patterns.
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