Post Views: 630 In Schedule M (Part I), Point 2.6 sits under “Warehousing Area” and requires that rejected, recalled, or returned materials/products are segregated in storage, with the area/items clearly marked, secured, and access restricted to authorized persons. Why Point…
Post Views: 651 In a risk-based inspection (RBI), Schedule M – Point 2.4 (Quarantine controls in warehouse/store) is assessed as a critical “quality gate” because quarantine is the main barrier preventing unreleased/untested materials or products from entering manufacturing or dispatch.…
Post Views: 662 In a risk-based inspection (RBI), Schedule M – Point 2.4 (Warehousing area) is assessed as a high-severity mix-up and quality-gate control, because quarantine is the main barrier preventing unreleased/untested materials or products from entering manufacturing or dispatch.…
Post Views: 762 In a risk-based inspection (RBI), Schedule M points 2.2 and 2.3 are assessed under warehousing and material movement controls, because weak storage/receiving practices can lead to temperature/humidity damage, contamination, mix-ups, and use of unreleased materials—all of which…
Post Views: 687 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…
Post Views: 661 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…
Post Views: 670 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…
Post Views: 717 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…
Post Views: 924 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…
Post Views: 808 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…
Post Views: 809 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…
Post Views: 913 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…
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