A supplier audit in pharma is a formal evaluation of vendors providing raw materials, packaging, or services. The aim is to ensure they comply with Good Manufacturing Practices (GMP), regulatory standards, and quality expectations. It is a critical part of...
India’s parliamentary panel has recommended decentralising medical device approvals to State Licensing Authorities. The aim is to reduce delays, improve efficiency, and strengthen competitiveness. The reforms target bottlenecks in CDSCO processes, especially for...
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,...