Post Views: 920 Risk Based Inspection (RBI) – Schedule M Point 1.1 in the CDSCO RBI checklist asks inspectors to confirm whether the entire manufacturing facility is separated, dedicated, and not part of any other non-drug facility. CDSCO Why this…
Post Views: 1,892 A Hormone is defined as a chemical released by a cell or a gland in one part of the body that sends out messages that affect cells in other parts of the organism. Only a small amount of…
Post Views: 3,369 HIRA (Hazard Identification and Risk Assessment) is a structured method for detecting and evaluating hazards in process facilities HIRA detects potential risks that may cause accidents, injuries, or environmental damage.
Post Views: 6,463 Preventive Maintenance in Pharmaceutical Industry Preventive maintenance in pharma is a planned, systematic approach to maintaining equipment, utilities and facilities so they remain in a qualified, reliable and GMP-compliant state. Instead of waiting for failures to happen,…
Post Views: 2,651 A User Requirement Specification (URS) is a formal document that outlines the needs of a user for a system, product, or service. In the pharmaceutical industry, a URS is a crucial document that ensures that equipment, processes, or systems…
Post Views: 2,359 The URS is a definition of requirements to fulfil the demands of the process from the Users’ point of view. The success of a GMP clean room design is dependent on a clear and concise User Requirement Specification…
Post Views: 1,717 Oncology in Pharma – Complete Overview Oncology is the branch of medicine that deals with the prevention, diagnosis and treatment of cancer. In pharmaceuticals, oncology is one of the most active and fast-growing therapeutic areas, with hundreds…
Post Views: 2,664 A User Requirement Specification for DPI is a formal document that defines the requirements for using a system in a regulated environment, such as a pharmaceutical facility. It’s a living document that can be updated as requirements change and…
Post Views: 3,089 What Is a URS for Ointments in Pharma? A User Requirement Specification (URS) for ointments is a formal document that defines what the end user expects from equipment, systems and facilities used to manufacture, store and pack…
Post Views: 2,484 A placebo is a “physiologically inert substance or sham intervention (psychological, physical or mechanical) which produces beneficial effects independent of any direct therapeutic effects”. The positive effects occur as a result of a patient’s expectations rather than as a result…
Post Views: 5,029 Occupational Exposure Level (OEL) is the maximum airborne concentration of a substance (usually an API or potent intermediate) that workers can be exposed to, safely, during their normal working day. In simple terms, OEL tells you “how…
Post Views: 5,232 Lyophilizer Qualification in Pharma is an important aspect in pharma. Lyophilization, also known as freeze-drying, is a process used to preserve a perishable material or make it more convenient for transport. It works by freezing the material…
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