Manufacturers and regulatory experts expect major transitions in inspections and enforcement. Contributing to this environment
are the US Food and Drug Administration's strong focus on product and process quality (see Figure 1), increasing numbers of
global business partnerships, and complex product technologies.
During an investigation, FDA can review everything "from [the] receipt of raw material through manufacture and any component
associated with laboratory testing" as well as "anything required or self-imposed by the firm to move through the manufacturing
stages," according to Michael Rogers, director of the Division of Field Investigations in FDA's Office of Regulatory Affairs.
Figure 1: FDA's quality system model.
Although the path to compliance with current good manufacturing practices (CGMPs) was never meant to be a one-size-fits all
strategy, there are some compliance issues that year after year continue to plague manufacturers. Cited observations relating
to quality control, out-of-specification results, process validation, sterility assurance, and contamination continue to be
of top concern (see "Fast facts" sidebar and Figure 2).
Fast facts (FY 2006)
"It seems like these are the same things I've seen for the past 20 years," says John C. (Jack) Garvey, vice-president of compliance
and quality management at The Weinberg Group (Princeton, NJ). "Part of the reason is that investigators, even when they are
using systems-based techniques, are still relying on the traditional methods of information gathering through the negative-product
experience—looking at product failures, deviations, and product complaints."
Figure 2: Top 10 drug observations used in FDA Turbo Establishment Inspection Report*, as of July 1, 2007.
Regardless of the situation leading to an inspection, industry and regulatory experts agree on several basic factors to take
into account during preparation.
Conduct a thorough risk assessment
Although good manufacturing practices (GMPs) have for the most part remained the same since the 1970s, increased computerization
and automation since that time means that risk assessment has taken a systems-based approach.
Industry is taking a more proactive look at ensuring well-characterized quality systems—those systems for which the link
between process requirements and their influence on product quality is well understood and scientifically sound. Companies
still must ensure that their standard documents as well as training and operating procedures are in place, but it is now in
the context of control-focused documentation. A company must ensure that an investigator understands the application of the
quality system to its product and the link between that documentation and essential product requirements.
"You can't just focus on the details and the particulars of doing something," says Chris Smith, vice-president of regulatory
affairs and quality at AAIPharma (Wilmington, NC). "Instead you focus on creating a process that will ensure quality every