Susan J. Schniepp
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In the pharmaceutical industry, the most frequently audited facilities are without a doubt contract organizations. These organizations
are constantly being audited by prospective clients, existing clients, global and domestic regulatory authorities, and their
own staffs. They deal with due diligence, regulatory quality systems, routine GMP inspections, preapproval inspections, and
internal audits on a monthly, if not weekly basis.
Audits can last anywhere from 1 day to 3 weeks depending on the type of audit being performed. In addition to typical audits,
such as yearly GMP assessments by clients and regulatory authorities, contract organizations can also be tasked with "for-cause"
audits by inspectors due to customer complaints or product recalls. Clients might also decide to perform a "for-cause" audit
if the contract organization manufactured a number of lots with associated investigations for deviations during the manufacturing
process.
To stay ahead of the audit game, contract organizations must have a system for handling audits that is efficient, consistent,
and flexible. A great deal of experience among the audit team is necessary because the team must be audit ready all the time
while also assuring that the company's other departments maintain an audit-ready posture. The group must have the ability
to host more than one audit at a time and be able to address questions and provide documents—in a timely manner—for as many
as three auditors per group. The team must also be prepared to provide some of the same information to more than one group
at the same time.
Admittedly, handling two separate audit groups with two to three auditors each is an unusual situation. However, let's say
that a contract organization has 14 clients and each client requires an annual GMP audit. To maximize audit time, each client
brings two auditors and plans for a 3-day visit. Considering that each audit requires one day of preparation and one day of
follow-up activities for the contract organization, each audit ultimately takes up one week of the organization's time.
Let's also assume that the contract organization is trying to attract new business. It has five potential new clients that
wish to perform a quality audit before entering into a contractual agreement. In addition, let's assume that the organization
provides sterile injectable products (or a similar product) to the global market, placing it in the high-risk category of
manufacturing. This classification would result in annual GMP audits from, at a minimum, the regulatory agencies of the US,
Europe, and Japan. Agencies typically spend 1 to 2 weeks conducting cGMP audits.
