
Corporate Structure
When your company is small, the personnel structure organization needs to be simple, yet efficient. One experienced general manager who works with a qualified person can easily manage the various functions that drive a GMP-compliant manufacturing facility. A very flat structure with few levels of hierarchy creates an environment that allows for quick decision-making and steady advancement. The most common starting structures can be seen in the chart below.
Quality Assurance
The QA Team is tasked with ensuring all areas follow all the necessary procedures and standard operating practices (SOPs) and check each step of the manufacturing process. Ensuring the integrity of the process as well as the quality of the products is what regulators desire to see in order to maintain a high degree of confidence. In larger companies, the Quality Team/Unit is usually headed by a Qualified Person (QP) whose job is to hire Quality Assurance Manager, Laboratory Control Manager, and Head of Regulatory Affairs.