Certify that your manufacturing process consistently produces safe, quality products
Good Manufacturing Practice (GMP) certification confirms that a manufacturer follows a system of processes, procedures, and documentation that ensures products are consistently produced and controlled to quality standards — covering everything from raw material sourcing and hygiene to equipment, personnel training, and record-keeping. GMP applies across pharmaceuticals, food, cosmetics, medical devices, and dietary supplements, and forms the operational backbone that other certifications (like HACCP, ISO 22000, or drug licensing) are often built on top of.
We help you implement GMP systems, prepare documentation, and coordinate certification with the relevant body for your sector.
Which GMP standard applies to you?
| Schedule M (India, pharma) | WHO-GMP | Food GMP (Schedule 4, FSSAI) | Cosmetic GMP (ISO 22716) | |
|---|---|---|---|---|
| Applies to | Drug manufacturers licensed in India | Pharma manufacturers seeking international/export credibility | Food manufacturers/processors | Cosmetic manufacturers |
| Issued/recognised by | Central Drugs Standard Control Organisation (CDSCO) / State Drug authorities | State Drug Authority, aligned to WHO guidelines | FSSAI | Accredited certification bodies against ISO 22716 |
| Mandatory or voluntary | Mandatory for drug manufacturing licence | Voluntary, but often required for export/tender eligibility | Mandatory baseline under FSSAI licensing | Voluntary, increasingly expected by buyers |
Who needs this: pharmaceutical and drug manufacturers, food and beverage processors, cosmetic manufacturers, dietary supplement producers, and medical device manufacturers (where GMP principles are embedded in Quality System Regulations).
Typical timeline: 3–6 months from gap assessment to certification, depending on the extent of facility upgrades needed to meet GMP infrastructure and documentation requirements.
Step 1 — Gap assessment
We evaluate your current facility, equipment, processes, and documentation against the applicable GMP standard to identify what’s missing — commonly infrastructure (layout, air handling, material flow), documentation (SOPs, batch records), and personnel training gaps.
Step 2 — Facility and infrastructure review
Manufacturing areas are assessed for appropriate design — separation of production areas to prevent cross-contamination, air quality/HVAC systems where required, water systems, and equipment qualification (installation, operational, and performance qualification).
Step 3 — Documentation system build-out
Standard Operating Procedures (SOPs) are developed or updated covering manufacturing processes, cleaning and sanitation, equipment maintenance, quality control testing, deviation handling, and change control.
Step 4 — Batch/production record systems
Systems are put in place for batch manufacturing records, in-process quality checks, and traceability — so every batch can be traced from raw material to finished product and back.
Step 5 — Personnel training
Staff are trained on GMP principles, hygiene practices, and their specific SOPs, with training records maintained as auditable evidence — a commonly checked item during certification audits.
Step 6 — Internal audit and mock inspection
An internal audit (or mock regulatory inspection) is conducted to surface any remaining gaps before the formal certification audit, giving time to close findings without consequence.
Step 7 — Certification audit
The relevant authority or accredited certification body — CDSCO/state authority for Schedule M, a WHO-GMP inspection team, FSSAI for food, or an ISO 22716 certification body for cosmetics — conducts an on-site audit of facilities, documentation, and practices.
Step 8 — Certification and surveillance
On successful audit, the GMP certificate is issued, typically valid for a defined period (commonly 2–3 years), with periodic surveillance audits or renewal inspections required to maintain it.
About the facility
Process documentation
Quality control
Personnel
Notes
Consistent product quality and safety
GMP systems are built specifically to reduce variability, contamination, and error in manufacturing — directly lowering the risk of substandard or unsafe products reaching consumers.
Regulatory and licensing requirement
For pharmaceutical manufacturers, GMP compliance (Schedule M in India) is mandatory for holding a manufacturing licence — it isn’t optional infrastructure, it’s the legal basis for operating.
Access to export markets
WHO-GMP certification is frequently required or strongly preferred by importers and regulators in export markets across Africa, Latin America, the Middle East, and parts of Asia — opening doors that non-certified manufacturers can’t access.
Reduces recall and liability risk
Traceable batch records and documented quality controls mean issues can be identified and contained quickly, significantly limiting the scope, cost, and reputational damage of a potential recall.
Builds buyer and institutional confidence
Government tenders, large distributors, and institutional buyers (hospitals, large retailers) frequently require GMP certification as a supplier prequalification condition.
Foundation for further certifications
A functioning GMP system substantially overlaps with HACCP, ISO 22000, ISO 13485 (medical devices), and ISO 22716 (cosmetics) — pursuing those becomes considerably faster once core GMP documentation and processes exist.
Operational efficiency gains
The discipline GMP requires — standardised processes, equipment maintenance schedules, trained personnel — often reduces batch failures, rework, and downtime as a side effect of compliance, not just a compliance cost.