The growing use of outsourcing by drugmakers is spreading the need for vendor audits across all areas of business. A regularly updated auditing and monitoring plan encompassing both internal and external operations represents one way to keep the risk of noncompliance in check, says Tim Krzeminski, director for project management and audit services at consultancy Compliance Implementation Services.
He cites several of the J&J/McNeil Tylenol recalls--some of those conducted after the Fort Washington, PA, plant shutdown--as evidence of the value of such audits. Inspections and production record audits led to discovery of noncompliance in additional areas, including labeling.
"Had they not detected the errors, triggering subsequent voluntary recalls, regulators could have detected them instead and consumers may have been negatively impacted," he says in an email. The result could have been even greater regulatory sanctions. "The audit detection also triggered J&J to perform a comprehensive quality assessment across its manufacturing operations, which should only strengthen controls in future operations."
Krzeminski said during a client webinar that as organizations transition operations to third-party vendors, internal auditors need to examine increased risks throughout the process. His talk focused on the clinical, manufacturing and commercial sectors represented by the 36 pharma attendees.
An informal poll of them showed that slightly more than half have an audit plan for the current year. Of the remainder, just 21% have a three-year audit plan they update annually. But a quarter of the respondents have no plan, according to a summary release.
- see the release