Welcome to GMP Concepts where we practice 'Compliance with Common Sense'. GMP Concepts is here to help your organization assess and audit your suppliers, identify compliance concerns, and propose corrective and preventive actions that will ensure not only a high quality product but also one manufactured under GMP compliant quality systems.
Each company out there is required to demonstrate their understanding of the compliance level at their suppliers and third parties. Often times the expectation is that you or a third party on your behalf has conducted an on-site audit of that supplier and/or third party. That said, the audit itself is only as good as the auditor executing it...
The auditors retained by GMP Concepts bring many years of experience and a wealth of knowledge from across all parts of the supply chain. Our audit universe includes:
- API Suppliers
- Raw material suppliers
- Suppliers of primary package components
- Contract manufacturers, contract packagers, contract testing labs.
We can also conduct internal audits of your facility.
At GMP Concepts, our specialty areas include (but are not limited to):
- Auditor qualification
- Systems Inspections
- Investigation writing
- Supplier Certification Programs
- Meaningful CAPA generation
At GMP Concepts, we handle our audits as 'projects'...a project includes:
- Audit Agenda/Plan
- On-Site Audit of the supplier/third party (based on the length of time you have negotiated with the auditee)
- Audit Report - in the clients' required format (this will include any back and forth between myself and the auditor
- Initial Assessment of the auditees' response - this is my personal assessment of the response and proposed action plan offered by the auditee (and recommendation to accept or not accept).