Ms. Boardley frequently evaluates FDA data on inspections and shares her insights. In her recent post she shared a table of the 10 most frequent citations in of Dietary Supplement Good Manufacturing Practices from FDA inspection reports:
|Specifications – identity, purity, strength, composition||55 (citations)|
|Written procedures – quality control operations||29|
|Specifications-component purity, strength, composition||28|
|Specifications – component identity||24|
|Written procedures – product complaint||22|
|Batch record – complete||21|
|Written procedures – holding||21|
|Specifications met – verify; finished batch||15|
|Component – verify identity, dietary ingredient||15|
|Master manufacturing record – each batch||14|
|Tests, examinations – scientifically valid||14|
It is the last item, Tests, examinations – scientifically valid, that is the key insight in the blog post. Ms. Boardley notes that 21 CFR 111.75(h)(2) has begun to appear in FDA Inspection Observations issued in 483 forms. Section 111.75(h)(2) requires that tests and evaluations to determine whether manufacturing specifications are met must use scientifically valid methods. As Ms. Boardley states,
“FDA’s focus during inspections is by now firmly fixed on examining the specifications you set for finished dietary supplements and their components, and ensuring that compliance with those specifications is tested using scientifically valid, fit for purpose methods. What does that mean in practice? It means you must be prepared to do due diligence, whether you use an internal or external third party lab, to ensure that the analytical methods used to test your supplements are scientifically valid for the product under test. In other words, you can’t just accept whatever method your lab prefers (or the cheapest method). You must understand the methods used and ensure the test will give accurate, reliable results in your particular situation.”
The post notes that “by input” is not an acceptable method of determining whether finished good specifications have been met and quotes FDA warning letters noting that manufacturers must document their choice of test method to demonstrate how/why the method will ensure that a product specification is met. Recent FDA warning letters also note that manufacturers must “verify that the laboratory examination and testing methodologies are appropriate for their intended use, as required by 21 CFR 111.320(a)”.
The blog post and its insights are a must read so you and your company can avoid an FDA warning letter.