statistics – Pharma GMP

Statistical Tools for Evaluating Uniformity of Dosage Units

digi — Wed, 26 Nov 2025 04:12:04 +0000

Statistical Tools for Evaluating Uniformity of Dosage Units Comprehensive Guide to Statistical Tools for Uniformity of Dosage Units in Process Controls The uniformity of dosage units in process controls is a fundamental quality attribute in pharmaceutical manufacturing, ensuring that each unit contains the intended amount of active pharmaceutical ingredient (API) within specified limits. Regulatory agencies...

How to Design a Statistically Sound In-Process Sampling Plan

digi — Wed, 26 Nov 2025 02:30:04 +0000

How to Design a Statistically Sound In-Process Sampling Plan Step-by-Step Guide to Designing an Effective In-Process Sampling Plan for Tablets In pharmaceutical manufacturing, in-process quality control remains a critical component to ensure product quality and compliance. A well-structured in process sampling plan for tablets supports real-time monitoring, trend analysis, and batch release decisions, minimizing risk...