May 19, 2021 · No matter what the procedure for a temporary change to a process is called, it is crucial that the procedure is clearly defined and does not allow changes to be made under the …

May 18, 2023 · Planned deviations are anticipated and approved in advance, typically due to a temporary change in processes or procedures. They’re controlled and documented to ensure …

May 19, 2020 · Any planned permanent or temporary departure or modification or addition or deletion from an approved/qualified …

Dec 10, 2023 · Planned deviations are also known as controlled deviations. These are pre-planned deviations and we know these before occurrence. These deviations are temporary …

Historically, the Pharmaceutical industry has called a “deviation” by two other names: either unplanned deviations or planned deviations. However, the regulators are asking industry to …

Mar 17, 2024 · In GMP, it's essential to distinguish that any deviation declared should not have been pre-planned; deviations are inherently unplanned changes. The topic of planned …

Apr 9, 2020 · If you know of the situation prior to starting the printing, it is a planned deviation. If the equipment stops working while you are printing, and you have to use the other printer to …

Temporary Changes (a.k.a. Planned Deviations) are pre-approved deviations from the current operational document or system, covering a specified period of time or number of batches. …

Oct 8, 2018 · 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 …

Jan 27, 2017 · I once worked for a company that used "deviation" and "planned deviation" to distinguish between those two situations. In some places "variance" is used in the "planned …