Process Mapping and Internal Regulatory Systems

Do you find your written procedures hard to follow and overly complicated? Do you have concerns about communication between your Manufacturing and Regulatory departments over changes to manufacturing processes and analytical methods? Process mapping is increasingly being regarded as an attractive solution to facilitate communication and interaction between departments, and development of streamlined internal procedures.

Process mapping involves the creation of a diagram or ‘map’ to identify all the steps and decisions in a process (see example below). It can improve and help to monitor processes to ensure efficient operations, thereby reducing time and cost. The ability to clearly identify the key interactions between each department within a company is critical to ensure maximum cooperation and increased regulatory compliance.


Change Control Procedures

Initiation of a change control procedure is often the start of a variation process.  It may be initiated by Manufacturing, Quality Assurance or Regulatory.  The output may then be required by any of those departments or others, for example, medical information or Supply Chain Operations, for implementation.
The change control output will provide an awareness of the projected or required time-lines for approval of the variation and essential implementation dates.  In addition, when applying a Quality by Design (QbD) approach, even though a variation submission may not be the result, a robust change control process will determine any process changes and their impact. Mapping of the change control process can help make it more efficient and can ensure that all departments clearly understand their responsibility throughout the process. This is critical to the successful introduction and understanding of the QbD concept.
Process maps can also be a useful starting point for writing internal procedures such as Standard Operating Procedures (SOPs). SOPs and other procedures written using a clearly defined process are generally easier to understand and more streamlined. Internal procedures developed with input from the whole team and which are based on process maps are more likely to be followed resulting in greater compliance.


Process maps are a valuable tool for any company facing constant regulatory and economic challenges. Making process mapping a part of the normal regulatory process and a constant feature which people use as a basis to work from will facilitate more consistent turnaround times and deliverables, even though the regulatory environment around is constantly changing. Visual processes and procedures which are easy to understand are thus wholly worth the time and effort it takes to create them.