3.2.P.1 Key Elements

Question 1

Clearly list the active ingredients and excipients. Each component must be identified with its function and quantity expressed in appropriate units.

Answer 1

Qualitative and Quantitative Composition

Question 2

Describe the formulation adequately. Specify the dosage form (tablet, injection, etc.), and ensure clarity on the method of manufacture and any critical intermediates.

Answer 2

Formulation

Question 3

Provide insights into the manufacturing process, including step-by-step procedures, controls, and any equipment utilized. This transparency helps build trust and ensures compliance with GMP regulations.

Answer 3

Manufacturing Process

Question 4

Present pivotal stability data that demonstrates the drug product’s shelf life and any necessary storage conditions. This reinforces its efficacy and safety throughout its intended use.

Answer 4

Stability Data

Question 5

Detail the packaging materials and protective measures that ensure product integrity and compliance with European standards.

Answer 5

Packaging Information