FALSIFICATION in Formulation Area

Hello. I’m a manager at a pharma company. I just learned that almost the entire formulation/compounding group has been falsifying cleaning records, not conducting cleaning and documenting it was clean, etc…

These are sterile injectable drug products. I’ve been tasked with conducting an investigation regarding the falsification. It was already decided the entire formulation department will be terminated.

Does anyone have any thoughts on what she be included in such an investigation?

Also, is falsification of this magnitude required to be reported to any regulatory agencies? In my case, the FDA?

The cleaning falsification in the compounding area has to have been going on for many years. A few of the (soon to be terminated) employees have been at my facility 22, 32 and 35 years.

Any input or ideas you can provide would be greatly appreciated. I know once I complete this investigation, I’m sure I’ll be the next to get terminated. Please Help

@Greg_S falsification of data in pharmaceutical and other industries is very common. I have seen it in many pharmaceutical industries but it is dangerous for the quality of products. People don’t take the cleaning process seriously and they become more flexible to skip cleaning when they see that there is not any problem when they are falsifying the cleaning data. It common and human tendency.

It shows that people don’t have training of cGMP and GDP and they have a casual approach. This casual approach towards the cGMP is really dangerous.

Now, ideally, you can add a checkpoint in the document where a QA person will check the cleaning process before signing the document and it must be done during the cleaning process.