Risk Based Inspection (RBI) – Schedule M Point 1.4 (as captured in the CDSCO RBI checklist) checks what measures your site has taken to ensure interior surfaces—walls, floors, ceilings and coving—are smooth, free from cracks/open joints, and permit easy cleaning.…
Schedule M “Point 1.3” depends on the version you’re using, so a risk-based inspection (RBI) should first align to the applicable text: If you’re using Notified Schedule M (dated 28 Dec 2023) 1.3 = Quality management. It defines quality management…
In a risk-based inspection (RBI) of Schedule M – Point 1.2 (Building and premises), inspectors treat facility design as a primary barrier against mix-ups, cross-contamination, microbial/particulate contamination, and pest ingress. Schedule M requires that buildings be designed/constructed/adapted/maintained to suit operations…
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 point is “risk-based”…
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 hormone is required…
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.
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, activities are scheduled…
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 meet regulatory standards…
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 (URS) to take…
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 of new drugs,…