The U.S. Food and Drug Administration has a lot of regulations that companies must obey to sell products that are safe for the public to consume. James Shores explains the ways that manufacturers can stay FDA compliant in this video.
Are there any differences in terms of compliance issues cross-country (or even regions)? Yes and no. In general, there are only minor differences in GMP. However, speaking of auditing, differences
almost always exist.
Regulatory authorities act as a guardian that ensures the safety, efficacy and quality of drugs available to the public, to identify the strengths and weaknesses of drug regulation and to propose strategies to improve drug regulation.