Posted on: 21st June 2017

The Storage and Transport workstream are setting out ways to standardize the validation of shipping lanes and equipment across the industry. Working with member companies to identify common problems, the team is to create a best practice process which will reduce the time to get medicines to market as well as save time and money.

Key to the development of this best practice will be to engage and align with suppliers within the supply chain, particularly active and passive shipper vendors, to ensure that the solutions developed will be implementable by all parties, as both sides have accountability in the qualification process. To that end, it is imperative that the various supplier groups are engaged now, to ensure that these key areas can be effectively addressed and that the supply chain is represented across the board to fully develop solutions.

The advantages of this best practice guide are clear: alignment of the industry with consistent approaches to OQ and PQ testing which will result in reduced qualification time for shipping lanes, reduction in resources required, reduction in repetition of work and reduced numbers of required shipping solutions. The ultimate outcome is a speedier time to market and significant financial savings for all parties.

Additionally, a harmonized approach to lane qualification will lead to improved submissions and clarity with the various regulatory bodies and as such lead to increased compliance.

While the workstream sits within the Drug Substance (DS) Phorum it is clear that the outputs developed will equally be applicable to both DS and Drug Product (DP) materials. As such, the workstream will be reaching out to their counterparts within DP to develop an integrated solution that benefits a much wider network of facilities and supply chains.

In parallel, the team is developing a longer term, strategic vision to meet the demands of the growing global market, in an increasingly complicated arena of low volume, high frequency distribution channels. This may include areas such as: harmonization of distribution risk assessment processes, supply chain integration, customs and excise compliance, addressing serialization and counterfeiting issues.

The intent is to publish a paper in 2018 having engaged with suppliers early in the process to develop a workable solution that fits both end users and suppliers. The team will also be presenting at conferences in the third quarter (Q3) of this year.

It is anticipated that an initial group of suppliers would participate in line with the next face to face meeting, provisionally planned for October 2017.

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