Posted By BB
Dear Learned-Bunch,

This is a fairly general question as I am trying to understand the myriad of regulation and standards that apply, or may be applied, to the pharmaceutical industry in the UK/EU.

Obviously process safety, batch traceability and GMP are paramount but who is likely to audit and set the bar (MCA, FDA etc)? What management systems are likely to be in place? (ISO 9001 derivatives?).

I appreciate that this may all depend on where the product is manufactured, what the processes and drugs are, as well as the end market, all information - or pointers are truly welcomed!

Thanks in advance!

Posted By Descarte
Safety regs depending on the site likely be COMAH DSEAR (dust and vapour) as well, CHIP, MSDS generation, ADR, manual handling, only other thing specific I remember being heavily involved in was occupational hygiene monitoring.