The subject of planned deviations made for a raucous “Breakfast with the FDA” session Sept. 25 at the Parenteral Drug Association/FDA conference in Washington.
These are the deviations from standard operating procedures that workers carry out on purpose, typically to keep a pharmaceutical plant operating when for one reason or another they won’t be doing it the way the company said they would.
“FDA Compliance Experts Advise Against Treating Minor Changes As ‘Planned Deviations’” – Bowman Cox, Pink Sheet
I wish I had gone to the PDA/FDA conference this year, if for nothing else to have been able to stand up and cheer wildly when this was said:
Brooke Higgins, a senior policy advisor in the FDA drug center’s Office of Compliance, agreed that “it’s a very strange term, and it kind of makes your skin crawl a little bit.”
There is a whole lot more good stuff over at the Pink Sheet’s summary.
I am a firm believer that there are no such things as planned changes. There are change controls, some of which are temporary, occasionally even ones that are retroactive (deviation identifies a change which is formalized in a change control). But all are through the same system, with the same evaluations and assessments and the same sorts of actions.
Keep all changes together. Its a true best practice.
Investigations of a Dog 