Technical Resources
When System Suitability Fails, the Batch Is Not...
System suitability is the least dramatic check in the laboratory and the most consequential. It runs before the samples, on a standard solution, and it asks one question: is this...
When System Suitability Fails, the Batch Is Not...
System suitability is the least dramatic check in the laboratory and the most consequential. It runs before the samples, on a standard solution, and it asks one question: is this...
The Test Is Only as Good as the Sample Behind It
Sampling error is usually larger than analytical error, and almost never measured. A plan that takes every sample from the top of every drum certifies the top layer, not the...
The Test Is Only as Good as the Sample Behind It
Sampling error is usually larger than analytical error, and almost never measured. A plan that takes every sample from the top of every drum certifies the top layer, not the...
Rework and Reprocessing: One Word Changes the File
Both recover a batch. Only one stays inside the process that was validated, and the difference is decided by whether the step already existed in the file.
Rework and Reprocessing: One Word Changes the File
Both recover a batch. Only one stays inside the process that was validated, and the difference is decided by whether the step already existed in the file.
Deviation Classification: What a Buyer Is Entit...
Most deviations that reach a customer are the ones that could not be hidden. The grading system is what determines which ones could, and whether that was a judgement or...
Deviation Classification: What a Buyer Is Entit...
Most deviations that reach a customer are the ones that could not be hidden. The grading system is what determines which ones could, and whether that was a judgement or...
Who Signs a Batch Release, and What Each Signat...
The name at the bottom of a certificate is doing less work than buyers assume. Release is a chain of decisions, and a signature is the last link rather than...
Who Signs a Batch Release, and What Each Signat...
The name at the bottom of a certificate is doing less work than buyers assume. Release is a chain of decisions, and a signature is the last link rather than...
TLC and HPLC See Different Impurities: Why It M...
When a certificate says no impurity was detected by thin-layer chromatography, it has made a statement about a threshold, not about the absence of everything below it.
TLC and HPLC See Different Impurities: Why It M...
When a certificate says no impurity was detected by thin-layer chromatography, it has made a statement about a threshold, not about the absence of everything below it.