Technical Resources
TSE/BSE Declarations for Animal-Derived APIs: W...
Animal-derived material brings a risk that no analytical test on the batch can rule out. The declaration is the only control, which is why a vague one is worse than...
TSE/BSE Declarations for Animal-Derived APIs: W...
Animal-derived material brings a risk that no analytical test on the batch can rule out. The declaration is the only control, which is why a vague one is worse than...
An API Supplier Scorecard: Eight Dimensions You...
A scorecard is only useful if two people scoring the same supplier reach the same number. That rules out most of the criteria companies actually use, which is most of...
An API Supplier Scorecard: Eight Dimensions You...
A scorecard is only useful if two people scoring the same supplier reach the same number. That rules out most of the criteria companies actually use, which is most of...
Why a QP Can Refuse Your Batch: Annex 16 in Pla...
Batch certification is a personal legal act, which is why it is not negotiated. Understanding what the QP is accountable for explains why a batch that passed every test can...
Why a QP Can Refuse Your Batch: Annex 16 in Pla...
Batch certification is a personal legal act, which is why it is not negotiated. Understanding what the QP is accountable for explains why a batch that passed every test can...
Three Consecutive Batches: What Process Validat...
The number three is a convention, not a process property. What validation establishes is whether the process holds inside its own variability, and three batches answer that only if chosen...
Three Consecutive Batches: What Process Validat...
The number three is a convention, not a process property. What validation establishes is whether the process holds inside its own variability, and three batches answer that only if chosen...
Do Bile Acid APIs Need a Mutagenic Impurity Ass...
A mutagenic impurity assessment is a decision tree, and the first branch asks whether the guideline applies. Skipping to the testing branch costs money; skipping the tree entirely wastes the...
Do Bile Acid APIs Need a Mutagenic Impurity Ass...
A mutagenic impurity assessment is a decision tree, and the first branch asks whether the guideline applies. Skipping to the testing branch costs money; skipping the tree entirely wastes the...
ICH Q11 Starting Material: How Far Upstream Is ...
The starting material decision looks like a chemistry question. It is a question about how much of the process you are prepared to describe, control and defend for the next...
ICH Q11 Starting Material: How Far Upstream Is ...
The starting material decision looks like a chemistry question. It is a question about how much of the process you are prepared to describe, control and defend for the next...