The pharmaceutical industry and the healthcare sector are subject to internal and external regulations aimed at ensuring the quality of a product or service and guaranteeing patient safety and effectiveness of medicines. Auditing is a way to assess an organization’s compliance with such internal and external regulations. It can be done for a variety of purposes, including routine inspections, new drug applications, or complaints or safety concerns.

How can Progress help you with this?

Progress has extensive expertise in the field of GxP, and specifically GMP regulations (Good Manufacturing Practice) in the United States and the European Union. Moreover, we have years of experience in the field of GMP-z (the standard for drug preparation in Dutch hospital pharmacies), GLP (Good Laboratory Practice), GDP (Good Distribution Practice) and GAMP (Good Automated Manufacturing Practice), against which audits are conducted. We can provide support in the following areas of auditing:

• Developing audit programs based on risk analysis, both internally
  (self-inspections) and external (suppliers).
• Conducting self-inspections at parts of your own organization, for example of your quality management system based on the United States Food and Drug Administration (FDA) Guidance for Industry Q10 Pharmaceutical Quality System.
• Conducting audits at suppliers of raw materials, materials, (semi) products or contract analyses.
• Preparing for pending (government) inspections, partly through mock audits that show how well an organization is prepared for a real audit.
• On-the-job training of your personnel in conducting and hosting audits.

Progress has extensive experience with auditing and has proven to be adept at setting up and implementing improvement plans based on audit observations for various clients. We ensure that organizations can respond effectively to audit findings and that improvement plans are in accordance with current and applicable regulations and guidelines. With more than 25 years of experience in the (bio-)pharmaceutical industry, we understand the challenges and requirements of delivering the highest quality medicines.

Progress offers various expertise (CMC and MSAT, Quality, Engineering and CQV and ATMP) and services (Consultancy, Project Management, Interim Management and Temporary Staffing).