Undergoing a GxP-compliance regulatory inspection is a challenge for any company or site staff. Since various individuals, and even multiple departments, participate in inspections, you need a high level of pre-inspection organization and planning. In previous blogs, we discussed how Inspection Management Software (IMS) tools like PSC’s AuditUtopia® can assist in providing organization and tracking of requests and documents during such an inspection. But who provides the answers to the Investigator’s technical questions? Time to introduce your Subject Matter Experts (SMEs).

Expert review

Identifying the Inspection Room Answer Team

How does a company or site determine not only the disciplines required to be “on call” for possible inspection support? Specifically, who are the SMEs to ask? Waiting until after an FDA Investigator has asked a technical question is the wrong time to start discussing who onsite may know the answer. Worse yet is having the Investigator wait for a surprised and unprepared person, who is hopefully an actual SME on the question at hand, to provide ad hoc answers to Investigators.

The recommendation is that SMEs are identified in advance and prepared for the role they may have to fill on a Site Inspection Team. This designation and role need not be formalized by job title but should be captured, maintained, and updated in some form of record accessible to Site Agents when/if needed. Below is only one example of a straightforward (and incomplete) format for such an internal plant SME list:

Subject Matter Expert contact chart

The type and amount of information in such lists is up to users. The fundamental aim is to quickly and accurately identify whom to refer a question and how to get in contact with them.

Which SMEs Are Needed?

Trying to determine everyone who may need to provide information in an inspection requires a bit of fortune-telling. However, site management is usually aware of past and present “hot topics” based on the nature of the site’s operations, regulatory history, etc. At a minimum, the following disciplines should be required to identify appropriate SMEs for inspection support:

    • QA/QC/Validation
    • Engineering/Maintenance/Calibration
    • Process Support/Technical Operations
    • Regulatory Affairs
    • Manufacturing/Operations

Preparation and training of the selected individuals should follow management approval of the SME list, as they are an essential part of your Inspection Management Team. Watch for future blogs on those topics!

Join Our Newsletter


Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

Follow Us

Share, Engage, Stay Current

Related Articles

Risk Assessment Methods – One Size Does Not Fit All

Risk Assessment Methods – One Size Does Not Fit All

Risk assessment is a key competency for modern Pharma/Biopharma organizations. Since the publication of ICH Q9 “Quality Risk Management” in 2005, the use of both formal and informal risk assessment tools has become a critical activity and a focus of regulatory...

Reviewing Documents 101

Reviewing Documents 101

When it comes to reviewing documents such as batch records, qualifications, validations, and other important documents, there are certain items that should be reviewed carefully. The reviewing of documents is a very important task within a company.  Let’s take a...

Stay In the Loop - Join Our Newsletter