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Pharmaceutical Manufacturing and Packing Sourcer
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The biopharmaceutical manufacturing sector is adopting new technologies and consumables at a fast pace to meet growth demands and increase flexibility. At the same time, regulatory authorities are putting pressure on biomanufacturers to have control over their full supply chains. Indeed, both manufacturers and industry working groups are placing increased emphasis on raw material and supplier management to help protect patients, enhance transparency and minimise risk (1-4). Additional concerns centre around events that might interrupt the supply of components needed to manufacture human health products.
Some suppliers are responding by investing in strategies, in-house expertise and human and system resources to help biomanufacturers meet these needs, but others are not as responsive. When choosing suppliers, a structured and risk-based approach is important.
A Holistic Approach
Ensuring that materials are available when needed is a key aspect of a supply chain security programme, but it is not sufficient for suppliers to focus on this alone. The products must maintain a high level of quality each time, and any changes must be communicated in a punctual and transparent manner. A comprehensive supply security strategy addresses these needs. One example of a holistic approach is based on three interrelated concepts (see Figure 1).
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News and Press Releases |
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Charles River Laboratories Announces Extended Relationship with The Michael J. Fox Foundation
WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL)
today announced an extension of its long-standing collaboration with The
Michael J. Fox Foundation for Parkinson’s Research (MJFF), a leading
organization working to support the diagnosis and treatment of
Parkinson’s disease (PD). Since 2011, Charles River and MJFF have worked
together to accelerate the discovery of therapies for PD. This latest
extension includes grants from MJFF to support two projects:
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White Papers |
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Transforming Temperature Data Management Practices to Reduce Labor Costs and Improve Visibility and Control
Berlinger & Co AG
There are a number of temperature monitoring database options available to the biopharma supply chain professional and choosing the right one can significantly improve workflow which will reduce administrative time. This article will provide insight into practices for improving common processes through enhanced database functionality in the areas of managing data loggers by expiry date, storing and retrieving calibration certificates and acknowledging/documenting common temperature excursion events. Additionally, it describes the unique features and benefits of the Berlinger Smartview® data management system. Smartview® is a “Software as a Service” (SaaS) platform designed to efficiently and accurately manage both workflow and data in a regulatory compliant manner (21 CRF Part 11 & Annex 11). This comprehensive temperature data management system ensures reliability, accuracy, security, accessibility, and visibility to supply chain professionals, enhancing Good Distribution Practices (GDP) of temperature sensitive shipments.
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Industry Events |
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SMi presents the 2nd annual conference on Pharmaceutical Microbiology West Coast
6-8 June 2018, Crowne Plaza, San Diego, CA, USA
SMi proudly presents the 2nd Annual
Pharmaceutical Microbiology West Coast Conference, in San Diego, USA, on
the 7th and 8th of June 2018. Delivering updates and promoting discussion
on key challenges and developments within the pharmaceutical microbiology
industry.
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