Data Integrity and Preservation in Pharmaceutical Manufacturing: Technology’s Role in Safeguarding Compliance Throughout a Drug’s Entire Life Cycle

Aug 6, 2018

The life sciences’ relationship with technology has come a long way since Deloitte’s 2015 global life sciences outlook describing it as ‘operating in an era of significant transformation.’ Since the report was published, most in the industry have re-evaluated traditional methods of operations, put to bed (or at least put a plan in place to deal with) ineffective, costly, and disjointed systems and practices, and are embracing the positive change innovative technology can bring. This article by Mark Stevens of Formpipe Life Science suggests embracing this technological revolution to get the most out of the pharmaceutical manufacturing process. ...

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The Falsified Medicines Directive – Are You Ready?

Aug 6, 2018

The Falsified Medicines Directive 2011/62/EU, which is due for adoption in February 2019, will require pharmaceutical companies to apply serialisation codes to every applicable pack (OTC and some minor exemptions). As a consequence, artwork changes will be required, which all too often are treated as a rushed afterthought. The impending legislation will affect all prescription medicines for the European market. In this article, Gill Wright from Westrock MPs advises the first step to comply with this legislation is to get your artwork amended and approved. ...

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Prefillable Vials for Dual Sourcing

Aug 6, 2018

Trends toward sophisticated, innovative medications and increasingly individualised medicine are increasing the quality demands on the primary packaging being used and are also creating a new division of labour between the pharmaceutical industry and packaging manufacturers. Quality-optimised ready-to-fill products enable the pharmaceutical industry to focus on its core areas of expertise and free up capacity by eliminating the washing and sterilisation of packaging. Maximilian Vogl of Gerresheimer explores how prefillable vials enable companies to comply with the relevant ISO standards and pharmacopoeias, whilst also making it possible to process a large number of primary packaging types with minimal conversion required. ...

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