blog

Introduction Define Good Manufacturing Practices (GMP) in the context of pharmaceutical manufacturing:- Good Manufacturing Practices (GMP) in the context of pharmaceutical manufacturing refer to a system of regulations, codes, and guidelines that ensure products are consistently produced and controlled according to quality standards. These practices are vital for maintaining the safety, quality, and efficacy of …

The Importance of Good Manufacturing Practices (GMP): How GMP Affects Drug Quality and Regulatory Compliance Read More »

Introduction Overview of the importance of understanding international drug regulations :- Understanding international drug regulations is crucial in today’s globalized world, where the pharmaceutical industry operates across borders and the movement of drugs, both legal and illegal, can have profound implications for public health, safety, and economic stability. The landscape of drug regulation is complex, …

Navigating International Regulatory Frameworks: A Guide to Drug Regulations Globally Read More »

Observation   1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm manufactures over-the-counter (OTC) drug products, including alcohol-based hand sanitizers[1]. During the inspection of your facility, our investigator attempted …

USFDA 483 on Access Management of Computerized System Read More »

Clinical data management leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. It ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the …

Clinical Data Management Read More »