Technical Resources
Remote or On-Site: What an Audit Can Actually V...
A remote audit can be deeper than a site visit on records and shallower on everything the eyes do. The honest answer to whether you need to travel is a...
Remote or On-Site: What an Audit Can Actually V...
A remote audit can be deeper than a site visit on records and shallower on everything the eyes do. The honest answer to whether you need to travel is a...
Annual Product Quality Review: What a Good One ...
A review that concludes there were no adverse trends has either examined the trends or defined them out of existence. The difference is visible in what the document counts.
Annual Product Quality Review: What a Good One ...
A review that concludes there were no adverse trends has either examined the trends or defined them out of existence. The difference is visible in what the document counts.
Batch Blending: Uniformity Is Not the Same as C...
A blend can make a specification easier to meet and a history harder to trace. The difference between a designed blending step and a quiet rescue is whether it appears...
Batch Blending: Uniformity Is Not the Same as C...
A blend can make a specification easier to meet and a history harder to trace. The difference between a designed blending step and a quiet rescue is whether it appears...
Cleaning Validation: The Number That Sets Your ...
Between two products on the same equipment sits a maximum allowable carryover. It is a number somebody calculated, and whether it was calculated well is a supplier question worth asking.
Cleaning Validation: The Number That Sets Your ...
Between two products on the same equipment sits a maximum allowable carryover. It is a number somebody calculated, and whether it was calculated well is a supplier question worth asking.
Chromatographic Integration: The Step Nobody Au...
A 0.05 per cent impurity can appear or disappear depending on where the baseline is drawn. Integration is a measurement step, and it deserves the same scrutiny as the weighing.
Chromatographic Integration: The Step Nobody Au...
A 0.05 per cent impurity can appear or disappear depending on where the baseline is drawn. Integration is a measurement step, and it deserves the same scrutiny as the weighing.
Not Detected, Below Limit, Zero: Three Differen...
Detection says a substance can be seen. Quantitation says a number can be trusted. Between the two sits every result on an impurity line, and most certificates never state where...
Not Detected, Below Limit, Zero: Three Differen...
Detection says a substance can be seen. Quantitation says a number can be trusted. Between the two sits every result on an impurity line, and most certificates never state where...