FDA Wants to Use Data Mining to Find High Risk Drug Manufacturers
April 23rd, 2013 // 2:40 pm @ jmpickett
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We all know that the pharmaceutical supply chain is very complex and spans the globe. This makes it difficult for FDA to pinpoint who the bad companies are and which products are the most dangerous. Most APIs are imported from India and China and other low cost countries. To keep well ahead of potential problems, FDA tries to do inspections for the plants that are the most risky.
Now, FDA is saying that it needs to implement a new software system that can go through large amounts of data to help it determine which plants are the most dangerous.
FDA’s idea is to come up with a Drug Quality Data Domain that will assist two FDA offices – Office of Scientific Investigations (OSI) and Office of Manufacturing and Product Quality (OMPQ) – that will help to decide which plant should be next for inspection.
- April 25 – How to Survive PREDICT – FDA’s New Import Screening Program
- April 29 – Audit Your Lab Like an FDA Auditor – A Roadmap to cGMP Lab Complance
- April 30 – How to Prepare Yourself for 21 CFR Part 11 Inspections
FDA wants to have an off the shelf software system that can conduct evaluation in real time, priority setting and report to support making of decisions for facility selection and inspection sites.
FDA said that it is searching for a vendor with a lot of experience in risk and trending analysis, and also simulation and modeling.It expects that this system will comb through information from many inspection and various other reports such as those for GCP, bioequivilance, REMS and pre and post approvals.
As we have seen in recent years with contaminated drug ingredients and counterfeit drugs, the supply chain for drugs is becoming very complex. FDA has more foreign drug/ingredient companies that it needs to track than it does of those in the US. cGMP inspections of foreign manufacturers increased 10% in 2012 to 812 inspections in 61 countries. It also relies more on auditors that are not based in the United States. Also, about half of the 45 warning letters issued to manufacturers abroad were from inspections from international FDA staff.
FDA also is setting up a new system that will let countries rely on internal audits. The US now imports almost 80% of its APIs and 40% of the finished drugs. This means that over the next 10 years, FDA is going to transform from a domestic-focused agency to one that is operating in a fully globalized economy.
Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:
- April 25 – How to Survive PREDICT – FDA’s New Import Screening Program
- April 29 – Audit Your Lab Like an FDA Auditor – A Roadmap to cGMP Lab Complance
- April 30 – How to Prepare Yourself for 21 CFR Part 11 Inspections
- May 1 – Avoiding Warning Letter Disasters With a Strong cGMP and GCP Quality Agreement
- May 2 – Avoid the CDRH eCopy Confusion – How to Prepare a Compliant eCopy Submission
- May 7 – FDA Recall Chief Update – How to Design a Bulletproof Recall Strategy
- May 15 – FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters
- May 16 – Spend $500K on Compliance or $300 Million on Consent Decree? – Essential cGMP Compliance Tips for Sr. Management
