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The West without Borders fundraising initiative had a terrific year in 2011 and as we kick off the 2012 campaign, we can look forward to another great year of aiding charities in the communities where West employees live and work. In 2011, West employees contributed more than $210,000 to aid local charities.
Diane Paskiet, Director Scientific Affairs, will provide an update on the PQRI-PODP working group at the Smithers Rapra Extractables and Leachables conference in Barcelona, Spain on November 10-12, 2014.
For the tenth consecutive year, teams from West Pharmaceutical Services are raising funds to support research at Fox Chase Cancer Center in Philadelphia. With the support of our families, friends and neighbors, the West team has raised nearly $1 million for Fox Chase since 2004.
Container closure integrity (CCI) is a critical factor every drug manufacturer and compounder is required to achieve. To achieve CCI, one must consider factors such as vial material, blowback, and stopper design. One vital factor – too often an afterthought – is the aluminum seal.
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market?<br />According to the European Union Regulation (EU) 2017/745 (MDR) Article 1(9), a prefilled syringe (PFS) is identified as “a single integral product which is intended exclusively for use in the given combination, and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable” (1). According to 2017/745 Article 1(9), you must prove that the device part of your combination product complies with the appropriate General Safety and Performance Requirements (GSPRs) laid out in Annex I of MDR. As you can no longer do a self-assessment, you will need to reach out to one of the currently designated 43 Notified Bodies in Europe (2) to do the conformity assessment for you. The results of the assessment are then captured in the Notified Body Opinion (NBOp) which you are required to include in the submission file to EMA or your national competent authority.
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