The pharmaceutical industry and the health sector are subject to internal and external regulations aimed at safeguarding the quality of a product or service. Conducting an audit is a way of testing an organisation’s compliance with such internal and external regulations.
How can Progress-PME help you with this?
Progress-PME has extensive expertise in the field of GMP regulations (Good Manufacturing Practice) in the United States and the European Union. Moreover, we have long 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 can be conducted. We can offer support in the following areas:
- developing audit programmes based on risk analysis, both internal
(self-inspections) and external (suppliers)
- conducting self-inspections in parts of your own organisation
- conducting audits at suppliers of raw materials, materials,
(semi-)products or contract analyses
- preparing for pending (government) inspections, also by means of
mock audits that show how well prepared an organisation is for a real audit
- on-the-job training of your personnel in conducting and hosting audits
Progress-PME has also proved itself adept at setting up and implementing improvement plans based on audit observations for various clients.