Regulatory Environment - Good Practices
So what is the regulatory environment?
The specific regulatory environment will entirely depend on the scope of the organisation’s activities. To discuss them all is not in the remit of this Module. However, to see a few common standards to illustrate the point please click on the links below.
There are specific laws and regulations which are applicable to many areas of activity. For example, within the pharmaceutical, agrochemical and clinical research industries there are a raft of legal requirements, including regulations setting out expected standards for performing certain activities. These are collectively known as the Good Practices or GxPs and would include, for example, Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice.
Good Manufacturing Practice is also a phrase associated with the food and engineering industries, which are also well defined by law.
Other National & International Regulations
There are innumerable other national and international regulations which are applicable to any particular activity and these form part of the regulatory environment for each organisation. Ensuring the organisation is fully cognisant of the regulations it needs to comply with is a critical part of business management.
