Validation master plans - Lapses in records seen as bug-a-boo in FDA inspections.

PHILADELPHIA Firms must be wary of lapses in their validation documents, including master plans, that would wave red flags during an FDA inspection, an industry consultant reported here at a Barnett International conference held Sept. 20-21.

"For instance, the tests described in the protocol must challenge all the process or equipment parameters described in the spec," said David Dills, corporate manager of quality services and regulatory affairs at Perigon, Jacksonville, FL.

Also, the FDAer will check to see if atypical data points are explained adequately in the validation conclusion or summary, he said. Referenced procedures should be available as an attachment or through the document control system. All deviations must be explained and qualified.

The sample size must be appropriate. "An FDA inspector would frown at the lame excuse that you failed to use a sufficiently large sample because your lab was unable to handle it," Dills said. "That's like saying you have no SOP because no one in QA knew how to create one."

Dills warned against writing a protocol after testing, rather than before. When he asked if anyone in the audience had ever done so, there were a few titters.

Lapses in validation records raise red flags in FDA audits, but master plans not required Dills He emphasized the importance of document clarity. "I once read a 25-page SOP and was lost by the first paragraph of the second page," he said. "An FDA inspector would definitely be less patient than I was. Avoid technical jargon and make sure it can be understood by a ninth grade student without the help of an engineer."

How long should a document be? Dills said: "I once reviewed a firm's validation master plan that was only one page long. It was adequate because the firm had only seven employees and produced one product with a single piece of equipment. Another firm might need 600 pages or more. "

Dills noted that FDA and the Quality System (QS) rules do not require validation master plans. Industry adopted master planning to control costs. "Validation costs then were running up to 13% of the total cost of installed projects," Dills stated. "Today, validation makes up approximately 8% of a project's budget."