by Dr. Yashashwini Reddy | Aug 12, 2025
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...
by Dr. Yashashwini Reddy | Aug 9, 2025
Out of Specification (OOS) Investigation in Pharmaceuticals Definition OOS results are test results that fall outside the pre-established acceptance criteria defined in specifications, procedures, or regulatory filings.They can occur in raw materials, in-process...
by Dr. Yashashwini Reddy | Jun 30, 2025
🧾 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...
by Dr. Yashashwini Reddy | Jun 30, 2025
📢 Reporting Complaints Related to FDA-Regulated Clinical Trials 🔍 1. Why Report a Complaint? Reporting complaints helps ensure: Protection of participant rights and safety Maintenance of ethical and regulatory standards Detection of misconduct, fraud, or GCP...
by Dr. Yashashwini Reddy | May 19, 2025
The U.S. Food and Drug Administration (FDA) has issued multiple warning letters to pharmaceutical and medical device manufacturers for deficiencies in cleaning validation processes. These letters highlight the critical importance of robust cleaning procedures to...
