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 as the total set of arrangements ensuring products meet intended quality, and states it includes GMP plus other factors like product design and development.
In RBI, inspectors test whether your Pharmaceutical Quality System (PQS) is effective for the highest-risk products/processes (e.g., sterile/critical steps, potent products, high-complaint products). The focus is not “do you have SOPs?” but “do SOPs prevent/quickly detect patient-impacting failures?” Key checks typically include:
- Management responsibility & quality governance: QA authority, batch disposition controls, independent decision-making.
- Quality risk management (QRM): risk assessments driving controls (cleaning validation, segregation, EM, supplier controls).
- Deviation/OOS/CAPA effectiveness: recurring issues, investigation quality, CAPA verification, timeliness.
- Change control & validation: changes assessed for impact, requalification triggers, ongoing process verification.
- Product Quality Review (PQR/APR): trends, complaints/recalls, stability, process capability, supplier performance.
Inspectors look for objective evidence: quality manual, KPIs and management review minutes, QRM reports, deviation logs, CAPA effectiveness checks, change control files, validation/qualification status, internal audit outcomes, and data integrity controls (audit trails, access, backup).
If you’re using the older Schedule M (Part I GMP text)
1.3 = Water System. It requires a validated water treatment system to produce Purified Water meeting pharmacopoeial specs, suitable storage that prevents microbial growth, periodic tank cleaning, and maintained records. IPA Pharma
Here, RBI targets water as a critical utility: validation state, sanitization/cleaning discipline, storage/distribution hygiene, microbiological control, trending, and rapid response to excursions—because water failures can directly contaminate product and equipment.