Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) defines the minimum standards for facilities, equipment, personnel, documentation, and processes that manufacturers must meet to produce safe, consistent, and quality products. The applicable GMP framework differs by industry — Schedule M under the Drugs and Cosmetics Act for pharmaceuticals, Codex Alimentarius GMP for food, and ISO 22716 for cosmetics — but the underlying principles are universal.
What is Good Manufacturing Practice (GMP)?
Good Manufacturing Practice is a set of regulations and guidelines governing how products are manufactured, tested, packaged, and stored to ensure consistent quality and safety. In India, pharmaceutical GMP requirements are defined by Schedule M of the Drugs and Cosmetics Act and Rules, and are enforced by the Central Drugs Standard Control Organisation (CDSCO). Food-sector GMP requirements derive from the Codex Alimentarius General Principles of Food Hygiene and are referenced by FSSAI regulations. Cosmetics GMP is covered by ISO 22716, which applies to the production, control, storage, and shipment of cosmetic products. All frameworks share common pillars: qualified and trained personnel, maintained facilities and equipment, controlled and documented processes, validated cleaning and hygiene procedures, robust record-keeping, and a functioning change-control system.
Who Needs It?
- Pharmaceutical manufacturers and contract manufacturers seeking CDSCO licence renewal or WHO-GMP certification for export.
- Nutraceutical, dietary supplement, and Ayurvedic product manufacturers regulated under Schedule M or GMP-aligned export standards.
- Food processors and manufacturers where FSSAI audit-readiness requires demonstrating Codex GMP implementation.
- Cosmetics and personal care product manufacturers supplying regulated markets (EU, US, Middle East) where ISO 22716 compliance is expected.
- Contract manufacturers and CMOs that must demonstrate GMP compliance to innovator clients as a condition of supply agreements.
- Medical device manufacturers for whom GMP is a foundational requirement before progressing to ISO 13485.
How Fusion Helps
Gap Analysis Against Applicable GMP Framework: We assess your current facility, documentation system, and procedures against the specific GMP standard applicable to your product category — Schedule M, Codex GMP, or ISO 22716 — and produce a prioritised gap report.
Facility & Equipment Review: We review your plant layout, material flow, equipment qualification status, and cleaning validation programmes against GMP requirements and recommend corrective actions.
SOPs & Master Documents: We develop or revise your Standard Operating Procedures, batch manufacturing records, cleaning records, equipment log books, and training records to meet GMP documentation requirements.
Personnel Training: We conduct GMP awareness and role-specific training for production, quality control, and warehousing personnel, including documentation discipline and personal hygiene requirements.
Pre-Inspection Readiness: We conduct a mock inspection simulating the approach of a CDSCO inspector, EU auditor, or client quality team, and prepare your team to respond to findings and observations.
Frequently Asked Questions
Fusion Certification is an independent consultancy providing certification guidance, documentation, implementation and audit-readiness support. Final assessment and certification decisions are made by the relevant independent certification body or scheme authority.