How can you prepare for an Industrial Design project's GMP audit or inspection?

1 Know the requirements

The first step to prepare for a GMP audit or inspection is to know the specific requirements and expectations of the regulatory authority or the client that is conducting the audit or inspection. Depending on the type, scope, and purpose of your industrial design project, you may need to follow different GMP standards, such as ISO 13485, FDA 21 CFR Part 820, or EU MDR. You should familiarize yourself with the applicable GMP standards and identify the critical areas, risks, and gaps in your design process. You should also review the audit or inspection agenda and objectives and prepare the necessary documents and records to demonstrate your compliance.

2 Train your team

The second step to prepare for a GMP audit or inspection is to train your team on the GMP standards and the audit or inspection process. You should ensure that your team members understand their roles and responsibilities, the design objectives and specifications, the quality system and procedures, and the potential issues and solutions. You should also assign a lead auditor or coordinator who will communicate with the auditor or inspector, facilitate the access to the documents and facilities, and resolve any queries or problems. You should also conduct internal audits or mock inspections to test your readiness and identify any areas for improvement.

3 Organize your documents

The third step to prepare for a GMP audit or inspection is to organize your documents and records in a clear and consistent manner. You should have a document control system that ensures the accuracy, completeness, and traceability of your design documents, such as design plans, specifications, drawings, validations, verifications, changes, reviews, approvals, and reports. You should also have a record management system that ensures the availability, security, and retention of your design records, such as test results, deviations, nonconformities, corrective actions, preventive actions, complaints, and feedback. You should also have a document index or map that helps the auditor or inspector to locate the relevant documents and records quickly and easily.

4 Prepare your facilities

The fourth step to prepare for a GMP audit or inspection is to prepare your facilities and equipment for the physical examination. You should ensure that your design facilities and equipment are clean, organized, calibrated, maintained, and labeled according to the GMP standards. You should also ensure that your design facilities and equipment are segregated, controlled, and protected from any contamination, interference, or damage. You should also have a contingency plan in case of any emergency or disruption that may affect your design activities or the audit or inspection process.

5 Cooperate with the auditor

The fifth step to prepare for a GMP audit or inspection is to cooperate with the auditor or inspector during the process. You should be courteous, professional, and honest with the auditor or inspector and provide the requested information and evidence in a timely and accurate manner. You should also avoid arguing, hiding, or falsifying any information or evidence that may compromise your credibility or compliance. You should also ask questions, clarify doubts, and seek feedback from the auditor or inspector to understand their perspective and expectations. You should also document the audit or inspection findings and observations and follow up on any actions or recommendations.

6 Implement the improvements

The sixth step to prepare for a GMP audit or inspection is to implement the improvements and corrections that result from the process. You should review the audit or inspection report and identify the strengths, weaknesses, opportunities, and threats in your design process and quality system. You should also prioritize and address the nonconformities, deviations, deficiencies, or gaps that may affect your compliance or performance. You should also monitor and measure the effectiveness of your corrective actions and preventive actions and verify that they meet the GMP standards and the audit or inspection objectives. You should also communicate and report your progress and achievements to the regulatory authority or the client and seek their approval or certification.