How do you ensure consistent GMP audits and inspections across regions?

To ensure consistent GMP audits and inspections across regions first of all we need to understand the compliances and regulatory requirements of the region and then make a simple checklist to fulfill those requirements by engaging the team members of all departments. Still, most importantly closure on the shared observation is important as GMP audit is for the betterment and smooth running of the operations and organization.

You have to carefully read the GMP requirements which your company is using during their normally followed production runs. If the GMP requirements which your company is following don't meet the criteria that the FDA or WHO require, you have to carefully examine them and make sure that you can enhance your GMP criteria to make sure that you can match the stringent standards set by the FDA and WHO. That will insure that you won't have any misunderstandings, non-compliance, or enforced delays.

Effective communication of audit findings is a critical aspect of the audit process, especially when it comes to sharing these findings with different regions. As businesses today are increasingly global in nature, many companies operate across multiple regions and countries. Therefore, it is important to ensure that the audit findings are communicated effectively to all stakeholders, regardless of their location. A great wat to do this in today's world is vis a SharePoint site or Teams page.

In my experience many companies aren’t consistently following all the requirements consistently to pass an audit without desperately trying to fix their issues the week of the audit. However, if they are following all the requirements to provide excellent quality products all of the time it wouldn’t be so much work to prepare for the audit.

I agree to a great extent. However, I also would point out that the FDA regulations are written like Law Book - many are generic in nature. The auditors are humans and differ in their interpretation of the FDA codes. You need to be confident in your interpretation and build systems and SOPs maintain compliance. And be ready to explain your views in case an Auditor challenge.

I agree. GMP regulations are/should be such that when followed, company is benefited. In most cases, it makes good business sense to follow them - reduce waste, no recalls, improved profitability. With that mindset, there will be commitment from top down to follow them.

A simple fundamental: if the back-up person for every activity can do the work of the usual person by following the procedures without supervision, it is unlikely that you will have a compliance issue. If this cannot be done, why not? A main goal of GMP or QSR is reproducibility by the appropriately trained staff.

As I am from food processing industry, I would like to add that how GMP is linked and very important with Food Safety Culture. In any food processing factory, GMP is strongly linked with a strong food safety culture plan. By involving every staff member, emphasizing adherence to SOPs and policies, and actively engaging in continuous improvement through the CAPA system, they not only ensured the safety of their products but also built a thriving and respected business in the industry. And so, their journey towards excellence continued, driven by the belief that a safety-conscious workforce is the heart of their success.

An examples that i’ve found in the field are the workers who ensure that the documents and records are clear, accurate, complete and up-to-date weren’t seriously care about the process & filling the documents. In my opinion the company should always have or point some “sharp” people to CONTINUOUSLY double check the documents for negligence because till now we’ve seen many cases of “human error mistakes” because of CARELESSNESS.