A GMP audit using a properly designed GMP gap analysis protocol is usually the first thing a Validation consultant is requested to perform on meeting a new client
Gap Analysis is designed to identify any government regulations and guidelines that apply to your company. Using our proven approach, our analysis will not only identify current regulations, but will identify any regulations and guidelines that are due to be implemented in the near term. Knowing about proposed regulations in advance of their implementation will allow you to understand and prepare for any changes and associated costs. Our Gap Analysis will highlight the critical parameters that apply to your distribution management systems and solutions. Our analysis will also identify any upgrades that are necessary to ensure that your business stays compliant with all regulatory requirements across all of the countries and jurisdictions in which you operate.
Our Gap Analysis process continually references:
- Applicable regulations and guidelines
- Product profile and stability information
- Shipping procedures
- Primary and secondary packaging processes and procedures
- Documentation management
- Warehouse and storage area monitoring
- Personnel training
- Transport procedures and policies
- Transport security
- and many other critical elements
During an inspection, a facility must be able to demonstrate that it is in a state of control. It may do so by having quality systems in place, knowing what the FDA expects and monitoring these systems. However, no matter how compliant a quality system is, if the manufacturer cannot successfully articulate it, the FDA will not get the message. As far as the agency is concerned, if something is not clear, then it is not happening at all.
Processes are to be in a state of control. Assuring that a process is in a state of control begins with defining what that process entails. All facilities maintain voluminous SOPs for exactly this reason. But the FDA wants to see that SOPs are not just resting in drawers, but are translated into action. Process maps become the tools for doing that. Process maps are the visual representation of SOPs, regardless of what quality system they address. The process map is the snapshot of how any given process is maintained in a state of control.
Gap Analysis and Preparing for Inspections
Even the most properly written SOP won't be followed correctly if it cannot be visualized. In some cases, employees might use a practice that is better than that in the SOP. Worse, they may be using a practice that is wrong. In order to find such compliance problem area, Our Process will guide manufacturers to create process maps of all practices—what is actually happening in the facility—and compare them against SOPs and regulations.
This "gap analysis" will identify differences between activities and expectations in the SOPs. Once found, either the SOPs or the practices can be revised, resulting in a new process map. Another tactic that firms use is the creation of a "future state" -- a process map of the ideal way to function that can then become the new SOP and practice.