Chief Pharmacist
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 ...
OEL and OEB in Pharmaceutical Industry
In pharmaceutical manufacturing, safeguarding worker safety is paramount when dealing with active pharmaceutical ingredients (APIs) and potent substances. Two crucial ...
Intrinsic Dissolution
In this chapter, we delve into the process of determining the intrinsic dissolution rate, a crucial factor in the characterization ...
Certificate of Analysis (COA)
A Certificate of Analysis (COA) is a document that certifies the quality and purity of a product or material. In ...
Quality by Design (QbD)
Quality by Design (QbD) is a systematic approach to pharmaceutical development and manufacturing that emphasizes designing quality into a product ...
Content Uniformity (CU)
Content Uniformity ensures that the active pharmaceutical ingredient (API) is evenly distributed in each finished dosage unit, such as a ...
Blend Uniformity (BU)
Blend Uniformity focuses on the homogeneity of the API in the powder blend before it is compressed or encapsulated. Purpose ...