Module 3.2.P

Question 1

Contains a detailed description of the dosage form, including a list of excipients, drug substance(s), and the intended use.

Answer 1

P.1: Description and Composition of the Drug Product

Question 2

Describes the formulation design, development process, and justification of choices for excipients and manufacturing processes.

Answer 2

P.2: Pharmaceutical Development

Question 3

Includes detailed information about the manufacturing process and controls, including flowcharts, process validation, and batch formula.

Answer 3

P.3: Manufacture

Question 4

Covers the specifications and quality control measures applied to excipients used in the dosage form.

Answer 4

P.4: Control of Excipients

Question 5

Focuses on the specifications, analytical methods, and acceptance criteria for the finished drug product.

Answer 5

P.5: Control of Drug Product

Question 6

Describes the reference standards used for testing the drug product, including potency and identity verification.

Answer 6

P.6: Reference Standards or Materials

Question 7

Provides information on the materials and packaging systems that protect the dosage form.

Answer 7

P.7: Container Closure System

Question 8

Describes the stability studies conducted on the drug product, ensuring it remains stable under various environmental conditions.

Answer 8

P.8: Stability

Question 9

This guideline outlines the critical parameters and acceptance criteria for drug products.

Answer 9

ICH Q6A (Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products)

Question 10

This guideline outlines the principles of quality by design (QbD), emphasizing a thorough understanding of the formulation and process development.

Answer 10

ICH Q8(R2) (Pharmaceutical Development)

Question 11

This document is critical to ensuring that the manufacturing practices meet regulatory standards.

Answer 11

ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)

Question 12

This guideline applies to risk management strategies, ensuring that excipient quality is maintained throughout the lifecycle.

Answer 12

ICH Q9 (Quality Risk Management)

Question 13

Relevant for ensuring the stability and quality of the drug product within the packaging system.

Answer 13

ICH Q1A(R2) (Stability Testing of New Drug Substances and Products) and ICH Q3C (Residual Solvents)

Question 14

Supports the data analysis needed for shelf-life determination.

Answer 14

ICH Q1E (Evaluation of Stability Data)