"Clear and precise" SOPs should be part of corporate compliance audit programs -- FDAer.

CORPORATE COMPLIANCE AUDIT PROGRAMS SHOULD HAVE "CLEAR AND PRECISE" SOPs for all manufacturing procedures and practices, including all possible "don'ts," FDA Office of Enforcement Deputy Director Arvin Shroff, PhD, told a Food & Drug Law Institute meeting July 11. The recommendations were included in Shroff's unofficial list of "points to consider" for auditing programs. Many standard operating procedures (SOPs) "are written so broadly just to appease FDA...that you can almost drive a truck through it," Shroff remarked. "When you write a very broad SOP, you can run into problems yourselves -- your own employees can misuse them," he warned.

The former FDA review chemist recounted an example of a nasal spray product with container specifications listed in the NDA that specified a certain supplier for the top and bottom container parts, which "fit very well." However, when the company used a cheaper container supplier "to save a penny" per bottle using the same NDA specs, "the parts didn't fit," which led to a large-scale recall of the nasal spray, Shroff said. "Nobody checked...whether those specifications were good or not. Actually those specifications were developed for FDA...and the firm paid for it."

Shroff also recommended the establishment of SOPs for regular announced and unannounced audits, and "would underline the unannounced."

Education in pertinent food and drug law and good manufacturing practices requirements should be part of corporate compliance training programs, Shroff said, as well as technical training in employee responsibilities. "Most of the problems we have noted over a period of time are because the employees had not understood what their roles are," Shroff said.

Other factors to fit into a compliance program, Shroff suggested, are an independent quality assurance/quality control unit to perform corporate compliance audits and independent audit reporting functions to minimize conflict of interest. He also suggested that companies make use of third-party consultants to review findings of both internal and external consultant auditing. "The reason for having another consultant take a look at the internal and external audit is sometimes [when] the internal auditor hires the consultant, the consultant is very reluctant to give a bad report," Shroff maintained.

The FDAer emphasized that the corporate audit suggestions are not agency policy. FDA is "not privy to all the ins and outs of a particular situation so, as a rule, we do not provide any advice in the QA/QC area because the management of a corporation or their philosophy can vary drastically," Shroff said.

Shroff applauded efforts by firms to establish effective internal compliance auditing programs, referencing "excellent presentations" given by three corporations at the FDLI conference, including an overview of the Mallinckrodt Group's corporate compliance program. "I'm gratified to learn that corporations are taking compliance audits seriously and are trying to do something about it," Shroff said.

FDA Mid-Atlantic Region Acting Food and Drug Director Joseph Phillips echoed Shroff's encouragement of the corporate programs. "Those firms that have strong corporate compliance audit programs have a greater probability of success in getting their applications approved," Phillips said.

The field director emphasized that FDA does not "by policy or practice" ask for copies of internal corporate audits. "If I begin to ask for your internal audits, I'm going to discourage you from doing internal inspections," Phillips said.

Phillips clarified areas of documentation required by the agency under GMP regs and laws "where, on occasion, there's a little confusion when we ask for some of the work you have done." Documentation under Sections 211.80 and 314.70 of the CFR pertaining to annual reviews and supplemental changes to an approved application are required by FDA, as is follow-up data on out-of-spec samples, Phillips pointed out.

He advised the FDLI audience "to keep these issues separate" and to "expect" FDA to ask for them. Phillips encouraged firms to maintain an internal compliance program and to "be assured that we're not going to use it against you" unless FDA is investigating possible fraud.