When it comes to manufacturing pharmaceuticals or medical devices, strict regulations are in place to ensure product quality and safety. The FDA in the US and EU GMP in the EU are two of the most well-known regulations.
Both organizations have their own set of auditing requirements that manufacturers must follow. This blog compares FDA and EU GMP auditing regulations. We will explain what you need to know.
Audit Approach
The first major difference between the FDA and EU GMP auditing requirements lies in the audit approach. The FDA employs risk-based audits to assess manufacturer compliance with relevant regulations and identify areas for corrective action. However, EU GMP standards prescribe production processes, paperwork, and quality control through GMP audit reports.
This means that the EU GMP audit focuses more on verifying compliance with specific requirements than identifying more general risks or areas for improvement.
Audit Frequency
Another key difference between the FDA and EU GMP auditing requirements is the frequency of audits. In the US, the FDA can conduct unannounced audits at any time, which can be nerve-wracking for manufacturers. However, they tend to be less frequent than EU GMP auditing and inspections, typically occurring every two to three years. Each production site must have a quality assurance (QA) system and self-inspect it, under EU GMP.
These self-inspections help identify improvement areas and demonstrate compliance with the regulations.
Audit Scope
A third difference between the FDA and EU GMP auditing requirements is the scope of the audit. EU GMP audits encompass the complete manufacturing process, while FDA audits focus on one product or procedure.
In addition, the EU GMP audit pharmaceutical requires manufacturers to have validation procedures for their processes and equipment. Manufacturers must demonstrate that their methods and equipment can generate high-quality products through testing and qualifying.
Documentation
One final difference between the FDA and EU GMP auditing service requirements is the required documentation. Both agencies require extensive documentation, but the EU GMP emphasizes the documentation of procedures and processes. This includes documentation of all manufacturing and quality control aspects, from raw materials to finished products. The EU GMP audit companies also require a quality manual that details the QA methodology and how it is implemented throughout manufacturing.
Conclusion
While the FDA and EU GMP regulations have a lot in common, some important differences exist in their auditing requirements. Understanding these differences is critical for manufacturers who want to ensure compliance with both sets of regulations. Manufacturers may reduce FDA and EU GMP audit risks associated with a FDA and EU GMP audit provider. They can ensure product quality and safety by proactively controlling their QA systems.