Chapter 2 - General principles and regulatory considerations: specifications and shelf life setting

Abstract

This chapter summarizes the specification requirements, for the drug substance (DS) and the drug product (DP), and sets the stage for the other chapters. The specification requirements for DS and DP are provided in the ICH guidelines Q6A (small molecules) and Q6B (large molecule). Those guidelines define universal tests applicable to all products and specific tests that apply to specific dosage forms. The ICH guidelines should be considered together with pharmacopeia requirements and regional guidelines inside and outside the ICH regions. Specific tests for complex dosage forms such as transdermal and inhalation products are not covered by ICH Q6A/B, which has led to regional guidelines and general chapters in the pharmacopeias. In addition to describing the regulatory framework for specifications, this chapter provides an overview of the statistical approaches to the development of acceptance criteria to ensure of the potency, purity, and performance over the shelf life of the product.