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Pharmaceutical Manufacturing and Packing Sourcer
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Managing regulatory compliance has always been a challenge for organisations, particularly those in the pharmaceutical space. Stakes are even higher today as companies must balance adherence to strict, often exhaustive, and continuously changing policies and procedures with the desire to embrace digital transformation and accelerate business to keep up with growing global competition.
This leaves the regulatory affairs, as well as quality and compliance personnel, in the middle, serving as the conduit between standards bodies or agencies, and senior leadership representing manufacturing, supply chain, and other key operational functions. The back-and-forth can be dizzying as one side expects compliance at all costs and the other desires getting product to customers faster and more efficiently than ever.
Labelling is one such area that crosses departmental boundaries. For manufacturing and supply chain, the barcode label is the passport that enables the fast identification, transport, tracking, and delivery of product from production line to endcustomer. For the regulatory manager, that same label must conform to a myriad of regulations and standards, many of which are a moving target due to constant change.
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News and Press Releases |
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PCI Clinical Services Announces New Facility Dedicated to Clinical Trial Returns
Philadelphia, USA – October 15, 2018. Leading international pharmaceutical outsourcing services provider PCI Clinical Services (PCI) has announced the completion of a dedicated Returns Management facility at its Clinical Services Center of Excellence at Bridgend, UK. PCI provides a full service Returns Management service for clients, providing visibility and accountability in returning investigational drug product from investigational sites at the conclusion of a clinical study. Returning and reconciling Investigational Medicinal Product (IMP) on completion of a study is a critical part of a Clinical trial and can require complex reverse logistics. Trial outcomes can be impacted if Returns are not processed efficiently and precisely.
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White Papers |
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Analysis of Biopharmaceuticals to Conform to ICHQ6B
RSSL
Worldwide, the pharmaceuticals market is anticipated to grow from more than USD 782 billion in 2011 to approach a value of just over USD 971 billion by the end of 2016, registering a CAGR of over 24%. In 2010 the average medicines expenditure per person within the UK was £271, and this is expected to increase with the ageing population. A significant and increasing proportion of these sales are protein-based biotherapeutics or biomolecules. Currently, these account for 19% of the total market, and are growing at twice the rate of traditional small molecule pharmaceuticals. It is predicted that close to 50% of the top 100 pharmaceutical products will be biomolecules by 2016. By far the largest segment of the biopharmaceutical market is the monoclonal antibody (MAb) with an estimated share of 25.6%, which corresponds to USD 51.1 billion.
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Industry Events |
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SAPHEX 2018
1-2 November 2018, Gallagher Convention Centre, Midrand, South Africa
The SAPHEX exhibition and conference is now established as the “go-to”
networking and business event for anyone working in the South African
pharmaceutical manufacturing industry.
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