Q13: Continuous Manufacturing

Q13: Continuous Manufacturing

Continuous Manufacturing (CM) is an advanced pharmaceutical production approach where input materials are continuously fed into the system and the processed output (finished product) is continuously removed. Unlike traditional batch manufacturing, which occurs in...
Difference between FDA 483 and Warning Letters

Difference between FDA 483 and Warning Letters

Difference Between FDA Form 483 and Warning Letter 1. FDA Form 483 (Inspectional Observations) Issued when: FDA inspectors observe potential violations of the Food, Drug, and Cosmetic Act (FD&C Act) during an inspection. Purpose: To notify company management of...
How to Submit a DMF (Drug Master File)

How to Submit a DMF (Drug Master File)

How to Submit a DMF (Drug Master File) A Drug Master File (DMF) is a confidential document submitted to the U.S. FDA that contains detailed information about the manufacturing, processing, packaging, and storage of drug substances, intermediates, or components.It is...
Informed Consent in Clinical Research

Informed Consent in Clinical Research

              🧾 Informed Consent in Clinical Research 🔍 1. What is Informed Consent? Informed Consent is a process by which a clinical trial participant voluntarily confirms their willingness to participate in a particular trial, after having been informed of all...

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