3.2.P.2.1.1

Question 1

Focuses on the information required for the Drug Substance in the Common Technical Document (CTD). It is a cornerstone for both regulatory affairs professionals and pharmaceutical developers striving to achieve compliance in the European market. This section ensures that the quality, safety, and efficacy of the drug are well-documented and conveyed clearly.

Answer 1

Section 3.2.P.2.1.1

Question 2

Understand the chemical composition, including the structure, molecular formula, and stereochemistry. Consider including detailed physicochemical properties to paint a complete picture of the drug substance.

Answer 2

Characterization

Question 3

Provide a thorough description of the manufacturing process, including raw material specifications. Details about critical steps should reflect Good Manufacturing Practices (GMP) compliance.

Answer 3

Manufacturing Process

Question 4

Each aspect of quality control must be addressed, from impurities to stability testing. Ensure robust methods are in place to meet stringent quality criteria.

Answer 4

Control of Drug Substance

Question 5

Document the stability data under stressed conditions. This not only informs shelf-life but also assures regulators of the product’s integrity over time.

Answer 5

Stability Data

Question 6

Outline specifications for packaging that maintain the quality of the drug substance.

Answer 6

Packaging and Storage