A robust system for continuous management of FDA-industry suppliers is necessary to assure the safety, identity, strength, quality, and purity of drug products. The initial qualification of a supplier will typically consist of an onsite assessment of the supplier, along with characterization and qualification of the supply. Once qualified, the quality agreement provides the basis from which on-going supplier management is achieved.
As per CFR 820.50 (Purchasing Controls), “Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.”
The FDA and ISO are looking to see that you have qualified your supplier. Simply stating that they are ISO certified, FDA registered, or work with that "large international medical device company" will not be enough. In many cases, critical suppliers must be audited. We can conduct audits to help you maintain compliance and ensure that compliant products are delivered to your company.
We can help your company with following services:
- Risk-based, supplier selection, evaluation, qualification & monitoring program design and SOPs
- Supply chain control mapping
- Compliance with FDA, ICH, IMDRF, and ISO requirements