During a recent FDA inspection, investigators uncovered the complete absence of supplier qualification for critical raw materials.
The firm manufactured, released, and distributed an API without conducting any evaluation or approval of the suppliers providing two critical starting materials. Both materials were incorporated into an API batch that was subsequently released by the manufacturing firm, processed into finished dosage forms, returned to the original firm for distribution, and sold through retail stores to consumers over a three-year period.
Supplier qualification is a critical control that ensures the quality and consistency of product. Without proper supplier evaluation, firms cannot verify that suppliers operate under appropriate quality systems, confirm the identity and purity of incoming materials, assess contamination risks, ensure supply chain traceability, or protect patients from substandard or falsified materials.
You can now utilize the new GMP Trends Dashboard to investigate the compliance history of a firm.
Our new product visualizes site inspection histories for pharmaceutical and medical device facilities since 2008. With our platform, learn whether a firm received NAI, VAI, OAI and the types of CFR citations received during an inspection. Also, quality teams can access 483’s in our 483 Database and view FDA Investigator Profiles. Our intelligence tool enables quality teams to identify patterns of non-compliance at potential partner sites, make risk-based decisions about supplier relationships, and monitor ongoing compliance trends at approved suppliers
The GMP Trends Dashboard builds upon our 47 years of service publishing the GMP Trends Report to support quality teams worldwide with quality intelligence information.
If you would like to schedule a call to view the GMP Trends Dashboard, please sign up with this link. Also, you can call or text our head of sales at +1 (732) – 609 – 6769 anytime 7AM EST until 8PM EST for an on-demand conversation.
Here is a link to FDA Guidance concerning Supplier Qualification
Here is a screenshot of the New GMP Trends Inspection Dashboard
