The QMS Gap Assessment is critical to ensure product development and manufacturing meets the regulatory requirements as a condition for a successful commercialization. A gap analysis attempts to identify whether the company has adequate processes, personnel, documentation and system in place to undertake a clinical trial that fulfils regulatory requirements for product marketing authorization.
In other words, a gap analysis helps the company to understand where it stands now, where it wants to be, and how to get there from a quality point of view. The key deliverable will be a detailed report that helps the company identify and remediate gaps between current practices and regulatory standards in its overall quality management system.
Gap analyses should be performed in the early phase of clinical development, as changes to the QMS become more challenging the further a product is in development. The team must consider the costs of time and money to not only change the procedure but to re-train personnel and alter ingrained behaviors.
A QMS gap analysis should be performed in sequential steps:
- Identify areas to be analyzed. This should be done according to the criticality of the processes or systems
- Prepare a checklist for the identified areas and include the major steps that must be followed during work. This should include all documents such as SOPs, protocols or work instructions.
- Gap analysis is performed to identify any shortcomings or differences between what is required in the checklist against actual working on the ground.
- Identify and record gaps found. The severity of the risks of the gaps should be recorded too.
- Write corrective action for each identified gap according to the predefined standard documents. This checklist should be forwarded to the respective department for implementation.
- Review the implementation of the corrective action and record the status of the checklist.
An excellent gap analysis for QMS processes would include a review of documented procedures, SOPs, and also interviews of key personnel involved in the product development process or QA/QC procedures. Obtaining input from these individuals allows the quality consultant to understand the client’s awareness of any gaps and their perception of these issues.
It is important to understand that a comprehensive gap analysis is not a one-size-fits-all project as a fixed template is ill-suited to the complex pharmaceutical quality assurance environment. The process should be agile where both the client and the QA consultants can modify the analytical approach based on the needs of the organization.
At the end of a gap analysis exercise, we will provide the following:
- A detailed written report that describes the difference between your current QMS and the requirements of a specific regulatory or industrial standard
- An understanding of the gaps (current and anticipated) and approaches to be taken to become compliant with the standard.
At Synergy Bioscience, we believe that gap analyses can deliver an “insurance policy” to ensure that the QMS is working as intended and gives our clients the confidence to progress to the next stage in their clinical trials or product developments.