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Pharmaceutical Manufacturing and Packing Sourcer

Supply Forecast

Packaging any pharmaceutical product can be a complex process. Ensuring a drug is packaged in compliance with the marketing authorisation and in a manner appropriate to environmental conditions requires detailed knowledge and experience, as well as having sufficiently trained staff and suitable facilities. This challenge is even greater if multiple drugs are being packaged for multiple markets at a single manufacturing site.

However, packaging products for clinical trials is arguably the most complicated and high-risk type of packaging work carried out in the pharma industry. The additional complexity introduced when there are numerous clinical sites means a detailed understanding of the regulations covering trials, as well as comprehensive knowledge of the study design and clinical protocol, is absolutely essential.

Various considerations in relation to packaging clinical supply will be discussed in this article, including the challenges associated with blinding supply and the impact that looming deadlines, such as that of serialisation, could have on the timescales and the overall cost of clinical trials. Overcoming these complexities through the introduction of new practices, such as just-in-time labelling, will also be outlined.

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Colin Newbould is Director of Regulatory Affairs and QP Services at Wasdell Group. He is also one of Wasdell’s QPs for certification to the European market. Colin has over 20 years’ experience in the pharma industry, and, having previously held management positions at PCI Pharma Services, Penn Pharmaceutical Services, and Catalent, Colin also has expertise in facility design and start-up, high potent manufacturing, managing supply chain quality, risk management, and continuous improvement. He holds a BSc in chemistry with analytical chemistry and toxicology, is a current management committee member of the Pharmaceutical and Healthcare Sciences Society, and has previous terms with the Pharmaceutical Quality Group.
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Colin Newbould
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