From "do you have an SOP"
to "can you demonstrate control."
Revised Schedule M isn't a longer checklist — it's a different question. The old standard asked whether procedures existed. The 2023 revision asks whether you can demonstrate systemic control through a Pharmaceutical Quality System, Quality Risk Management, and Product Quality Review. ValiCore is built for the second question.
What is Schedule M, and what changed in the 2023 revision?
Schedule M is the Good Manufacturing Practices standard under India's Drugs and Cosmetics Rules, 1945. The revised version — notified December 28, 2023 — introduced three new formal requirements: a Pharmaceutical Quality System (PQS, senior-management-owned, spanning the full product lifecycle), Quality Risk Management (QRM, a documented, structured risk-assessment discipline), and Product Quality Review (PQR, periodic review of product quality trends). It also mandates formal equipment qualification and validation, and a computerised storage system for drug product records. The revision was explicitly designed to align Indian GMP with WHO TRS 986 and EU GMP — closing the credibility gap between Indian manufacturing standards and the export markets Indian pharma serves.
Built for
What goes wrong without it
PQS exists on paper, not in daily operation
A Pharmaceutical Quality System that's a policy document nobody actually operates against isn't a PQS an inspector will accept — it needs to show up in how CAPA, change control, and deviations are actually run.
QRM applied inconsistently, or not at all
Quality Risk Management is now a named, checked requirement — not a nice-to-have. A risk assessment done once for a validation report but never applied to routine operational decisions doesn't satisfy the intent.
No computerised record-keeping system
Revised Schedule M explicitly calls for a computerised storage system for drug product records. Paper logs and disconnected spreadsheets are precisely what this requirement was written to move away from.
What ValiCore actually does here
PQS operationalized, not just documented
CAPA, change control, deviations, and document control all flow through one system — the PQS is how the platform actually runs, not a separate binder.
Schedule M (Revised) · ICH Q10Structured Quality Risk Management
Risk assessments as a first-class, trackable record — applied to change control, supplier qualification, and deviation handling, not confined to one-off validation exercises.
ICH Q9 · Schedule M QRMProduct Quality Review support
APQR module aggregates batch trends, complaints, deviations, and stability data into the periodic review Schedule M requires.
Schedule M PQRComputerised, tamper-evident record system
Every GMP record — calibration, QC, batch, deviation — lives in one hash-chained, audit-trailed system, satisfying the computerised-storage requirement directly.
Equipment qualification & validation tracking
IQ/OQ/PQ workflows with full evidence chains — the formal validation Schedule M now explicitly requires.
Inspection-ready in days, not weeks
Every module — PQS, QRM records, PQR, validation evidence — exportable on demand for a CDSCO inspector, not reconstructed under deadline pressure.
Regulations this addresses
Related modules
Frequently asked questions
PQS — Pharmaceutical Quality System — is revised Schedule M's requirement for a senior-management-owned quality system spanning the entire product lifecycle, not just manufacturing. It's the philosophical center of the 2023 revision: rather than checking whether individual SOPs exist, an inspector assesses whether the organization can demonstrate systemic, ongoing control over quality — CAPA effectiveness, change control discipline, and risk-based decision-making working together as one system.
Large manufacturers (above the specified turnover threshold) had 6 months from notification, reaching effective compliance by June 28, 2024. Small and medium manufacturers had 12 months. Manufacturers who didn't file for a compliance extension became subject to immediate CDSCO inspection as of January 1, 2026 — with reports indicating only an estimated 10-12% of eligible firms applied for extension, meaning the large majority are now live under active inspection exposure.
Revised Schedule M was explicitly designed to align with WHO GMP (TRS 986), so the two share the same core philosophy — PQS, risk management, lifecycle-based quality. Schedule M is the mandatory domestic Indian standard; WHO-GMP certification is typically pursued separately by manufacturers targeting export markets or WHO prequalification, and involves its own certification process even for a facility already Schedule M-compliant.
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