Specification
How to Set Impurity Limits in Drug Products
Step-1: Classify the peak by origin Step-2: Map the dominant formation pathway and whether it’s avoidable Amlodipine besylate tablets example: Step-3: Apply the correct regulatory ruleset + exposure thresholds Step-4: Convert limits into analytical requirements Step-5: Link each limit to control level (control strategy) Related: Pharmaceutical Impurities Calculator Resource Person: Pearl Pereira ... Read More
Pharmaceutical Raw Material Specification and Template
A raw material specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. When a specification is first proposed, justification should be presented for each procedure and each acceptance criterion included. The ... Read More
Pharmaceutical Finished Product Specification and Template
As per ICH Guideline,A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. When a specification is first proposed, justification should be presented for each procedure and each acceptance criterion included. ... Read More