[PDF] Inspektions-Zertifikat - Anciens Et Réunions

Who conducts a pre-approval inspection?

• The Pre-Approval Inspection team If an inspection is determined to be needed FDA will send a team of individuals to conduct the pre-approval inspection. The team may include: •Investigators •Other Specialists –Chemistry Expert –Microbiology Expert –Process/Facility Expert –Formulation Expert Pre-Approval Inspection Program (7346.832)

What is a risk mapping inspection?

• Risk Mapping Safety Inspections The third inspection method is called risk mapping. It is a good method to use at a safety meeting where everyone there is familiar with the workplace or process. This technique uses a map/drawing of the workplace or a list of steps in a process.

What information should an inspector communicate during an inspection?

• During an inspection, inspectors should appropriately communicate information about the process and the nature of the inspection to the various parties involved to help them understand such things as the inspection objective(s), time frames, data needs, and reporting process.

What are inspection procedures?

• Inspection procedures should provide for supervisory review and other safeguards to protect the inspection findings and reports against distortion by the personal feelings and biases of any party to the inspection. Findings often have been regarded as containing the elements of criteria; condition; effect; and, when problems are found, cause.