Cleaning program- PDA

 

It is important to consider the effect that weekends, holidays and delays might have on the cleaning schedule.

It is advisable to determine the stability of material remaining on equipment for longer time
periods than in a normal manufacturing sequence.

Material typically may degrade, dehydrate or may strongly adhere to equipment after long time periods. It may be advisable to establish the stability of the product in the manufacturing equipment for the longest (i.e., worst case) holding period.

Regulatory inspectors are known to be quite interested in how the company has taken the stability and cleanability of materials into account when materials sit in equipment for long periods of time.

The product reserved in the open container should be evaluated for product degradation studies.

The validation group, user group, quality assurance group, etc. are all responsible for ensuring that the test program is an accurate reflection of actual production.