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Hisho & Kanri
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GMP Certification

Prove your production line meets global quality standards.

Good Manufacturing Practice (GMP) Certification confirms that your manufacturing facility, processes, and quality systems consistently produce goods that are safe, pure, and effective — whether you make pharmaceuticals, food products, cosmetics, supplements, or medical devices. It's issued after an independent audit of your premises, equipment, staff training, hygiene practices, and documentation.

For manufacturers, GMP isn't just a wall certificate — it's often the deciding factor in whether a distributor lists your product, a regulator clears it for sale, or an export buyer signs the purchase order. Missing or lapsed GMP status can quietly block deals long before anyone mentions it outright.

Talk to a GMP Compliance Expert Who Needs GMP
0Facilities Certified
0Countries Covered
0Avg. Certification Time
0First-Audit Pass Rate
GMP Quality Registry Facility Compliance Record
Certified
Certificate Reference
GMP20260417
StandardWHO-GMP / Schedule M
Facility StatusAudited & Active
Filed ByHisho & Kanri
On-Site Audit Verified
Use Cases

Which manufacturers actually need GMP Certification?

GMP isn't limited to pharma plants. Here's the full range of manufacturers and processors where certification is expected — or legally mandatory.

Pharmaceutical Manufacturers

Mandatory under drug-manufacturing law for any facility producing formulations, APIs, or finished dosage forms for sale.

Most Common

Food & Beverage Processors

Demonstrates hygienic processing and safe handling, often required before retail chains or export buyers will onboard you.

Nutraceutical & Supplement Makers

Confirms consistent potency and purity for tablets, capsules, and powders sold as dietary or health supplements.

Cosmetics & Personal Care Manufacturers

Covers contamination control and formulation consistency for creams, lotions, and personal-care products.

Medical Device Manufacturers

Applies alongside device-specific regulatory approvals to verify the production environment meets quality standards.

Ayurvedic & Herbal Product Units

Required for licensing herbal and traditional-medicine manufacturing units under most national drug-control regimes.

Contract & Third-Party Manufacturers

Brand owners routinely require their contract manufacturing units to hold current GMP status before signing a supply agreement.

Exporters of Regulated Goods

Many destination countries won't clear customs for pharma, food, or cosmetic shipments without proof of GMP compliance.

The Process

From gap assessment to certificate, in eight steps

Here's exactly what happens between your first facility review and holding a valid GMP Certificate in hand.

Gap Assessment
Documentation
Staff Training
On-Site Audit
Certified
1

Facility Gap Assessment

We review your current layout, equipment, and hygiene practices against GMP requirements to flag every gap before the real audit.

2

SOP & Documentation Build-Out

Standard operating procedures, batch records, and quality manuals are drafted or corrected to match actual practice on the floor.

3

Facility & Equipment Upgrades

Corrective work — from ventilation to equipment calibration — is completed wherever the assessment found shortfalls.

4

Employee Training

Production and QA staff are trained on hygiene, documentation discipline, and the specific SOPs they'll be audited against.

5

Internal Mock Audit

A dry-run audit surfaces any remaining non-conformance while there's still time to fix it before the official visit.

6

Application to Certifying Body

Your formal application, facility details, and supporting documentation are submitted to the relevant GMP certification authority.

7

On-Site Certification Audit

An independent auditor inspects the facility, reviews records, and interviews staff to confirm sustained GMP compliance.

8

Certificate Issuance

Once the audit is cleared, your GMP Certificate is issued — valid for a fixed term and renewable through periodic surveillance audits.

Eligibility

Who can apply for GMP Certification?

Requirements vary slightly by product category and certifying body, but most facilities need to demonstrate the same baseline before an auditor will sign off.

Registered Manufacturing Entity

A legally registered business operating an active production or processing facility at the audited address.

Defined Quality Management System

Documented SOPs, batch records, and a quality-control function, even if informal, that the auditor can review.

Adequate Facility Layout

Production areas designed to prevent contamination, cross-mixing, and pest entry, with proper material and personnel flow.

Trained & Identifiable Staff

Personnel assigned to production and quality roles, with records showing they've been trained on relevant SOPs.

Calibrated Equipment

Manufacturing and testing equipment maintained and calibrated on a documented schedule.

Applicable Statutory Licenses

Any product-specific manufacturing license (drug license, FSSAI, cosmetic license, etc.) already in place or in process.

Paperwork

Documents you'll need to keep handy

Auditors work off records as much as the floor walk-through — having these organized upfront noticeably shortens the audit.

Business Registration Certificate

Proof of your legal entity

Factory / Facility License

Local manufacturing or factory permit

Facility Layout Plan

Site plan showing production flow

SOPs & Quality Manual

Documented standard procedures

Batch Manufacturing Records

Recent production and QC logs

Equipment Calibration Records

Maintenance and calibration logs

Staff Training Records

Proof of hygiene & SOP training

Product-Specific License

Drug, FSSAI, or cosmetic license copy

Why It's Worth It

What GMP Certification actually buys you

Beyond passing an audit, certification changes how buyers, regulators, and retailers treat your product from the first conversation onward.

Verified Product Safety

Independent proof that your process controls contamination risk

Export Market Access

Meets the entry requirement for most regulated import markets

Retail & Distributor Acceptance

Chains and distributors onboard certified manufacturers faster

Stronger Brand Trust

Customers and buyers read certification as a quality signal

Fewer Product Recalls

Standardized process control catches defects before shipment

Smoother Contract Manufacturing Deals

A prerequisite most brand owners now check before signing

Better Internal Process Control

Documentation discipline reduces waste and batch failures

Easier Access to Institutional Buyers

Hospitals, governments, and large retailers often mandate it

After Certification

Staying certified, audit after audit

GMP status isn't a one-time achievement — here's what keeps your certificate valid and your facility audit-ready year-round.

Periodic Surveillance Audits

Scheduled re-inspections by the certifying body to confirm continued compliance.

Batch Record Maintenance

Ongoing, accurate documentation of every production batch and quality check.

Equipment Calibration Schedule

Regular calibration and preventive maintenance logged for all production equipment.

Refresher Staff Training

Periodic retraining on SOPs, hygiene, and any updated regulatory requirements.

Complaint & Recall Handling

A documented process for investigating product complaints and managing recalls if they occur.

Certificate Renewal

Timely renewal filing before expiry to avoid a lapse in certified status.

Why Hisho & Kanri

GMP certification handled by people who audit for a living

We've prepared facilities across India, Singapore, and Malaysia for GMP audits, and know exactly which non-conformances trip up first-time applicants.

Experienced Quality Consultants

Specialists who've prepped facilities across pharma, food, and cosmetics.

Faster Audit Readiness

Structured gap-closure plans instead of open-ended consulting.

Transparent Pricing

Clear packages with no hidden consulting-hour surprises.

Full Visibility Into Findings

Every gap and corrective action is documented and shared with you.

Dedicated Support

One point of contact from gap assessment through certificate issuance.

Confidential Handling

Your facility data and SOPs are handled under strict confidentiality.

FAQ

Common questions about GMP Certification

Can't find your question here? Use the form alongside this page and we'll answer it directly.

It confirms your facility, equipment, staff practices, and documentation consistently produce safe, consistent-quality goods, verified by an independent audit.

For regulated sectors like pharmaceuticals it's typically compulsory; for food, cosmetics, and supplements it's often expected by buyers even where not legally forced.

Typically around 3 weeks once documentation and facility gaps are resolved, though timelines vary with how audit-ready the facility already is.

Business registration proof, facility layout, SOPs, batch records, and staff training logs — see the Documents section above for the full list.

An auditor inspects the facility, reviews documentation, interviews staff, and checks that actual practice matches your written SOPs.

Most certificates run for a fixed one to three-year term and require periodic surveillance audits to remain valid.

You'll receive a list of non-conformances to correct, after which a follow-up audit or documentation review can be scheduled.

Yes — facility size doesn't disqualify you, but the same documentation and hygiene standards apply regardless of scale.

No, it works alongside them — GMP certifies your manufacturing process, while product-specific licenses authorize the product itself.

Because we handle facility audits daily across three countries, close gaps before the official audit, and stay on to help you retain certified status long-term.