Designing and planning a pharma manufacturing facility require a delicate balance between engineering and regulatory compliance. Emphasis has to be laid on regulatory compliance, operational efficiency, risk management, and future scalability. Properly designed...
In pharmaceutical industry, a non-conformance is any deviation from approved specifications, procedures, or regulatory requirements. It can affect product quality, safety, efficacy, or compliance. It signals that a process, product, or documentation has failed to meet...
Current good manufacturing practices (cGMP) provide a robust framework of guidelines regulating every step of the drug manufacturing process. Every aspect from raw material procurement to final product distribution is strictly regulated. The goal is to deliver safe,...
SUGAM is the official CDSCO license application portal. It is a single-window online system for regulatory submissions. It ensures faster approvals and clear digital tracking of submissions. Central Drugs Standard Control Organization (CDSCO) has announced a new SUGAM...
Visual inspection in the pharmaceutical industry is a critical quality control step. Pharma visual inspection is a systematic examination of pharmaceutical products (often 100% of units) to identify visible defects before release. It is primarily applied to sterile...