Ageing facilities & drug shortages: industry concern drives guidance for manufacturers
The Points to Consider for Ageing Facilities document (available to purchase in PDF format), developed with input from the PDA and the Ageing Facility Task Force, is based on responses to an ageing-facility-focused workshop and survey held in 2015.
PDA co-chair and G-CON Manufacturing CEO Maik Jornitz said the document begins with indications and recognition that a facility is ageing, and highlights strategies and impediments for modernisation.
“The elaborate timeline for post approval changes are addressed and what impact it may have on starting a modernisation activity,” Jornitz told in-PharmaTechnologist.
“The document also lists possibilities to slow down aging or enhancements to process controls, which would create an in-depth control over an aging process. It discusses risk assessments for the different parts of a site, from facility to processes to analytics and these parts of the site could be improved,” he said.
A move to curb drug shortages
According to the PDA, noncompliant, aging facilities is one of the reasons firms cease manufacturing, which consequently contributes to drug shortages.
“The Points to Consider document is a direct outcome of the Ageing Facility Task Force, which was formed because aging facilities became a major point of discussions, especially as reasons for drug shortages or stock-outs,” explained PDA co-chair Maik Jornitz.
“Publications and discussions within the industry showed that aging facilities are a major contributor to quality issues, possible recalls and respectively drug shortages. Considerable concerns were voiced about the rise of drug shortage issues and an analysis showed that we need to look at ageing facilities as a possible culprit, but also how to remediate the problem,” said Jornitz.
Low on injectables
Jornitz said contract manufacturing organisation (CMO) Ben Venue’s 2013 facility closure is an example of ageing facilities affecting the manufacturing industry.
Ben Venue was founded in 1938, expanded its capabilities in 1987, and again in the 1990s.
The sterile injectables maker, which was owned by Boehringer Ingleheim, ceased production in Ohio, US after the facility failed to comply with current Good Manufacturing Practices (cGMP).
Ben Venue’s quality deficiencies were largely responsible for drug shortage issues in the US earlier this decade.