GMP Certification & Schedule M Compliance
Maintain your pharmaceutical manufacturing license and expand into global export markets. SNB Consultancy provides expert gap analysis, quality management documentation, and audit readiness support for Revised Schedule M (Drugs & Cosmetics Act) and WHO-GMP certification.
Good Manufacturing Practice (GMP) ensures that products are consistently manufactured and controlled according to statutory quality standards. In India, pharma manufacturing compliance is split between mandatory licensing conditions (Revised Schedule M) and voluntary export certifications (WHO-GMP).
Our GMP & Schedule M Compliance Services Include:
- Clause-by-clause gap analysis against Revised Schedule M and WHO-GMP guidelines
- Drafting Site Master Files (SMF), Validation Master Plans (VMP), and Standard Operating Procedures (SOPs)
- Corrective and Preventive Action (CAPA) logging and risk management protocols
- Form COS-7 self-declaration preparation for Cosmetics Seventh Schedule compliance
- Schedule T compliance and Form 26E-I filing for Ayurvedic, Siddha, and Unani (ASU) units
Understanding GMP Requirements in India
Revised Schedule M vs. WHO-GMP: Revised Schedule M under the Drugs & Cosmetics Rules is a mandatory statutory condition for holding a pharmaceutical manufacturing license in India. On the other hand, WHO-GMP is a voluntary certification granted directly by CDSCO after factory audit, required primarily for overseas drug exports and international tenders.
Regulatory Framework Across Manufacturing Sectors
| Manufacturing Sector | Governing Schedule & Rule | Compliance & Licensing Body |
|---|---|---|
| Pharmaceutical Units | Revised Schedule M (Good Manufacturing Practices) | State Licensing Authority & CDSCO |
| Pharma Export Units | WHO-GMP Certification Framework | Central Drugs Standard Control Organization (CDSCO) |
| Cosmetics Manufacturers | Form COS-7 & Seventh Schedule (ISO 22716 alignment) | State Drug Controller (Post-license site inspection) |
| Ayurvedic / ASU Units | Schedule T (Rule 157) & Form 26E-I Certificate | AYUSH State Licensing Authority |
Documents & Records Required for GMP Audit
- Site Master File (SMF): Detailed description of manufacturing facility layout, air handling units (AHU), water systems, and equipment.
- Validation Master Plan (VMP): Equipment qualification (DQ, IQ, OQ, PQ) and process validation protocols.
- Batch Manufacturing Records (BMR): Complete execution logs for production batches, raw material testing, and analytical certificates.
- CAPA & Deviation Registers: Logs documenting quality deviations, root cause analysis, and corrective actions taken.
How SNB Consultancy Assists Your Unit
- Diagnostic Facility Inspection: Our pharma compliance auditors inspect premises, HVAC, and cleanrooms to highlight gap areas.
- Quality Management System Documentation: We draft your SMF, VMP, SOPs, and stability testing protocols.
- Audit Readiness File Preparation: We assemble a defensible compliance dossier for State and CDSCO drug inspectors.
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Partner with SNB Consultancy for expert gap assessment, SOP drafting, and regulatory audit filing.
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