Inspection Readiness and support
Regulatory inspections are key instruments for governments to control compliance with regulations and marketing authorizations.
Timely preparation for an inspection is crucial to ensure the organization is well prepared and that the inspection runs smoothly. Experience has shown that inspection preparation should be well organized and managed. Preparation is a team effort, requiring central coordination and involvement of various disciplines.
We can help you to get ready for the inspection.
We have experience with successful preparation of many regulatory inspections by the Dutch Health and Youth Care Inspectorate (IGJ) and the United States Food and Drug Administration (FDA) including routine inspections and PLI/PAI supporting marketing authorization of new products.
Activities may include:
- GAP assessments: identification and remediation of inspection risks.
- Training of SMEs facing the inspectors
- Practice facility tours (mock tours).
- Training laboratory technicians and operators being observed by inspectors.
- General inspection training on Do’s and Don’ts. The actual inspection: what to expect.
- Creation of story boards, helpful to prepare for questions on e.g. complex deviations or to explain the manufacturing process.
- Project Management support
QMS support
A robust Quality System (QMS/PQS) is not only regulatory requirement to ensure product’s pharmaceutical quality and patients’ safety. A well-structured QMS/PQS also contributes to the effectiveness and operational efficiency.
We can help you to identify gaps in the current system and support in defining and delivering a fit-for-purpose QMS/PQS. Typical activities may include:
- GAP analyses by comparing current procedures with applicable GMP requirements and regulatory guidelines.
- Creating a well-structured QMS. Use of templates and authoring instructions.
- Writing and reviewing SOPs.
- Project management support
If you are interested and would like to discuss opportunities please feel free to contact WPC.
See other services as well: