SOP Development and Implementation for the FDA-Regulated Industry

How to effectively write an SOP to ensure compliance

What is an SOP? In an organization, it is an operation-specific procedure that gives a thorough description of all the activities needed to carry out tasks that comply with industry-related regulations, State laws, and many a time, the methods the organization itself has prescribed for its business. Documentation is at the heart of a solid SOP. The core of developing an SOP is how the organization systematizes its processes and documents them.

A procedure must necessarily describe the manner in which to carry out a certain activity, or what is called the “how to” of it. SOPs are a set of standards, procedures, principles and policies that go on to streamline core areas such as finance, HR, administration, marketing and many others.

Many advantages and benefits accrue from putting in place a sound SOP. These are some of them:

• The organization’s efficiencies go up
• They help put in place a healthy workplace environment, and help meet regulatory requirements
• The organization’s products and services carry higher quality, and are more consistent and reliable
• The error rate in most activities comes down
• SOPs are a ready reference to resolving disputes between Business Associates.

learn More