Blog
Site Master File (SMF)
For pharmaceutical and medical device manufacturers, a Site Master File (SMF) is more than just a document—it’s a blueprint of ...
Letter of Authorization (LOA)
In the pharmaceutical industry, Drug Master Files (DMFs) play a critical role in maintaining the confidentiality of proprietary information related ...
Marketing Authorization Holder (MAH)
Any company, firm or non-profit organization, which holds a marketing authorization granted by the European Medicines Agency (EMA), is called ...
Orphan Drug
An orphan drug is a medication developed to treat rare diseases (also called orphan diseases) that affect a small percentage ...
Understanding CEP, DMF, CADIFA and ASMF
CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) DMF (Drug Master File) CADIFA (Certificado de Adequação de ...
Post-Approval Changes in Pharmaceutical Industry
Post-approval changes in pharmaceutical companies refer to any modifications made to a drug product or its manufacturing process after receiving ...
Key Aspects of SUPAC Guidelines
SUPAC (Scale-Up and Post-Approval Changes) is a set of guidelines issued by the U.S. Food and Drug Administration (FDA) to ...
Overall Equipment Effectiveness
Overall Equipment Effectiveness is a key performance metric in manufacturing that measures how efficiently equipment is utilized. It is calculated ...
Granulation in Pharmaceutical Industry
In the pharmaceutical industry, granulation is a critical process used to improve the flowability, compressibility, and uniformity of powders before ...
Exhibit Batches in Pharmaceutical Industry
In the pharmaceutical industry, Exhibit Batches are manufactured to demonstrate and validate that a drug product or API (Active Pharmaceutical ...