In a risk-based inspection (RBI), Schedule M point 2.1 (Warehousing area) is assessed as a mix-up and quality-preservation control, because storage weaknesses can trigger wrong-material use, status errors (quarantine vs released), deterioration, contamination, and recall failures. Point 2.1 requires adequate…
In a risk-based inspection (RBI), Schedule M – Point 1.7 is assessed to confirm that the Product Quality System (PQS) is clearly defined and documented, and that a Quality Manual (or equivalent) exists and describes the quality management system including…
In a risk-based inspection (RBI), Schedule M (Oral Solid Dosage Forms) – Point 1.6 is assessed as a cross-contamination and foreign-matter prevention control. The requirement is clear: the manufacturer must guard against any material lodging and remaining undetected in processing…
In a risk-based inspection (RBI), Schedule M – Point 1.5 (Pharmaceutical Quality System) is verified by checking whether your PQS actually ensures consistent product quality across the full lifecycle—not just that SOPs exist. Point 1.5 requires the PQS to ensure…
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.