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...
Self-inspection in pharma companies is a planned, systematic internal audit process aimed to evaluate processes, facilities, and systems. It is designed to ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal quality...
With increasing complexity of FDA regulated products and critical nature of patient safety, proper management of product recalls is essential. Hence, understanding US FDA product recalls is of vital importance to remain compliant. A US FDA product recall is an...