In-house committee to review changes, sticking with change program advised by McNeil exec. (Change control).

PHILADELPHIA -- Manufacturers may want to consider creating an in-house committee to review and approve changes in manufacturing processes, document those decisions and stick with SOPs continually to avoid 483s.

Such is the manner in which McNeil Consumer and Specialty Pharmaceuticals is handling change control, said Rose Mary Dollard, who is in charge of developing and maintaining qualification, validation and change control systems for the Ft. Washington, PA-based firm.

Addressing a Barnett/Parexel meeting here June 27, Dollard said that besides creating a "change control committee" comprised of staff from different departments within a firm, any changes should be defined ahead of time, with all relevant parties' responsibilities delineated.

Dollard argued that the procedure for change control should include filing a standardized form for submitting the change request, followed by evaluation, review and approval of the change request, execution of the change with documentation, review and approval of implementation and post-change tracking.

She acknowledged the latter may seem obvious, but it is a particularly crucial, and often missed step to change procedure. "You want a program, a systematic way of tracking changes. There's no use having one, if you can't use it on the back end," Dollard argued.

Important throughout the process is to keep documents as specific as possible.

"You can get a 483 for having too vague a description of your change, so when you do it, be sure to be detailed, so it meets the requirements," Dollard added.

In general, Dollard said she favors a holistic approach to change, keeping a broad eye on how the change fits into the company as a whole. She argued it is important, for the purposes of evaluation and approval of changes, to create a list of processes and systems potentially affected by the change, including manufacturing, products that are under NDA, NDA supplement or ANDA and controlled documents, such as SOPs. If a change in a cleaning procedure is an increase or decrease in time or temperature, for example, revalidation will be required.

"A change might even require revision of engineering drawings," Dollard added. The more prepared a company is for the aftershocks of a change, the more likely it is that they will remain compliant and validated.

Once the change control program is in place, all of the outlined procedures for change should be followed, even if changes must be implemented during night shifts. "Stuff that happens at 2 a.m. is just as critical as stuff that happens during the day," she said.

Dollard reminded the conference that changing processes and systems is both natural and necessary for process improvements, for cost efficiency, for adapting to new regulatory requirements and for upgrading to suppliers' new materials. Changing helps companies stay up to validation standards, not just the FDA's but international regulations as well.

But changing any element of a cleaning process could put a firm at risk for noncompliance or what she termed "non-validation." For this reason, effective change control in cleaning systems is crucial. The important thing is to create a change control program that works, and stick with it.