GMP Tips

Here are more lessons from the peanut butter salmonella case.

1. During an FDA inspection of Peanut Corporation of America (PCA) in 2001, FDA found equipment “repaired” using duct tape. A private audit in 2008 found duct tape still being used.

2. Many of the customers of PCA relied upon audit data that PCA supplied them from a third-party auditor that PCA had hired. One customer, Kellogg’s, spent less than $20M on PCA products, and now estimate their recalls will cost them $70M.

3. Nestle sent their own auditors in to inspect PCA’s plants and rejected PCA as a supplier. Do you suppose their audits cost less than $70M to conduct?

Read an article with details that will cause your jaw to drop. Go to:
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GMP Tip

1. Don’t ever, ever use duct tape to “fix” equipment. Conduct GMP training. Make sure your people know not to use duct tape. It is a source of microbial contamination.

2. Conduct vendor audits. Remember last year we had issues with heparin coming from a vendor in China that had not been audited by the customer. Conducting supplier audits are an insurance policy. The consequences of not conducting audits is ALWAYS higher than the cost of conducting them.

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Validation Evolution: Are We Abandoning IQ and OQ?
How to Comply with FDA’s New Changes for Process Validation
May 1

Outsourcing in the Healthcare Industry: How to Avoid the Perils and Pitfalls
May 7

Defining Risk and Risk Levels: Implementing ICH Q9
May 14

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Methods Development and Validation Procedures for the Analytical Lab
May 27 Philadelphia, PA

Good Laboratory Practice (GLP)
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GMP Boot Camp: Fundamentals of GMP/QSR
Jul 15 – 16 Anaheim, CA

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