Risk-Based Inspection (RBI) lets regulators decide the frequency, depth and breadth of GMP inspections using Quality Risk Management, focusing more effort on systems that could impact patients, product quality, and users. CDSCO
Schedule M – Point 4.4 (What it requires)
Schedule M 4.4 states: “Areas housing animals shall be isolated from other areas.” It further requires that animal house provisions follow Rule 150-C(3) of the Drugs & Cosmetics Rules, 1945, adopted for production/testing purposes.
Why 4.4 becomes high-focus in RBI
Animal facilities introduce unique GMP risks: microbial/zoonotic contamination, allergens, odor and waste contamination, pest attraction, mix-ups in biological testing, and reputational/regulatory risk. Under RBI, if a site performs in-vivo tests (e.g., biological assays, pyrogen-related work where applicable, vaccine potency tests), inspectors treat animal housing as a high-risk interface between testing and GMP operations—especially if the same site also manufactures sterile or high-risk products.
What RBI inspectors verify (practical evidence)
- Physical isolation & access control
- Separate building/wing, controlled entry, restricted movement pathways so animals, feed, bedding, and waste do not pass through production/QC corridors.
- Dedicated change/handwash/gowning steps for animal house staff.
- Facility suitability per Rule 150-C(3)
Inspectors check compliance with the rule’s expectations, including: adequate area, lighting, ventilation and air-conditioning for animals undergoing tests; hygienic housing and removal of excreta/foul smell; arrangements for animal feed preparation; quarantine for newly received animals; periodic fitness checks; isolation of sick animals and animals under test; compliance with the Prevention of Cruelty to Animals Act; and safe carcass disposal without public-health hazard. - Contamination and waste controls
- Cleaning/disinfection SOPs, pest control, waste segregation, and evidence that animal waste/effluent handling cannot contaminate GMP areas.
- Quality-system linkage
- Training records, incident/deviation reporting (e.g., sick animals, sanitation failures), change control for animal facility modifications, and documented oversight that the animal house does not compromise GMP controls elsewhere.
In RBI terms, poor isolation or weak animal-house controls often triggers expanded inspection scope into environmental controls, sanitation, utilities, and QC governance because the contamination risk is systemic.