The basic elements are:
- An appropriate infrastructure or “quality system” encompassing the organization structure, procedures, processes and resources
- The systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for “Quality”
The totality of these actions is termed “Quality Assurance”
There are two basic elements of this aspect of the management function of a pharmaceutical company:
A working infrastructure = quality system. This includes:
A company needs to have a plan to develop all these items and a statement of its intent to carry out that plan. It is only when all the elements of the plan have been carried out that there is a system of quality management in place. Any company or organization making pharmaceuticals should show that there is a structure - an organization dedicated to making the products correctly. This structure must have the backing of the most senior management of the company to be sure that it will succeed.
Systematic actions to bring the quality policy to life. The totality of these actions is termed quality assurance (QA).
Inside an organization, QA is a management tool. In contractual situations, it provides confidence in the supplier. An important part of the systematic actions is the availability of a complete system of standard operating procedures. These are normally known as SOPs. They describe all the actions that need to be taken in a standardized way. This means that everyone involved in pharmaceutical manufacturing has a book of procedures that guides them in the way that they should do their job. It provides a standardized way of working.