A pharmaceutical cleanroom is a highly controlled environment designed to minimize contamination during drug manufacturing. Airborne particles, temperature, humidity, and pressure are strictly regulated in a clean room. Setting up a pharma cleanroom requires a...
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...