GMP Certification Readiness: Good Manufacturing Practice Compliance for Regulated Manufacturers
GMP readiness for pharmaceutical, dietary supplement, food, cosmetic, and medical device manufacturers. We assess your manufacturing, sanitation, validation, and records against the GMP rules that apply to you. Then we help you close gaps before an inspection or certification audit. Most programs take 6–12 weeks.
Page reviewed 29 September 2026 by the Accredify Global compliance team.
What Is GMP Certification?
GMP certification is evidence that a manufacturer follows Good Manufacturing Practice: the controls that make sure products are consistently made to their quality standard. Depending on your sector and market, that evidence comes from a regulator's inspection, a third-party audit, or a certifiable standard such as ISO 22716.
GMP covers people, premises, equipment, materials, processes, and records. In practice, it asks whether trained staff follow written procedures in clean, controlled facilities. It also asks whether processes and equipment are validated, and whether every batch can be traced and investigated.
Accredify Global prepares you for whichever route applies. We assess current practice, prioritize corrective actions, and organize the procedures and records an inspector or auditor will ask for.
Is There a GMP Certification? Who Actually Confirms GMP Compliance
There is no single GMP certificate. In the US, FDA enforces current Good Manufacturing Practice (cGMP) through inspections under sector rules. These are 21 CFR Parts 210 and 211 for drugs, Part 111 for dietary supplements, Part 117 for human food, and Part 820 for medical devices. In the EU, national authorities inspect manufacturers and record GMP certificates in the EudraGMDP database. Many other regulators follow WHO GMP.
For cosmetics, the Modernization of Cosmetics Regulation Act (MoCRA) directs FDA to set GMP rules; as of early 2026, final rules had not been issued. ISO 22716 is the international cosmetics GMP standard, and it is certifiable. Buyers and retailers often add their own requirement for a third-party GMP audit or certificate.
Sources: FDA: CGMP regulations · EMA: EudraGMDP · Foley: MoCRA in 2026
GMP Requirements by Sector, and How Compliance Is Confirmed
The first question in every GMP project is which rules apply to your products and markets. This is how the main routes compare.
| Sector | Main GMP reference | How compliance is confirmed |
|---|---|---|
| Pharmaceuticals | 21 CFR 210/211 (US), EU GMP, WHO GMP | Regulatory inspection; certificate issued by EU and other authorities |
| Dietary supplements | 21 CFR Part 111 | FDA inspection; buyers often ask for a third-party GMP audit |
| Food | 21 CFR Part 117 (US), Codex hygiene principles | FDA inspection; HACCP or ISO 22000 certification for buyers |
| Cosmetics | ISO 22716; MoCRA rules to come in the US | ISO 22716 certification, which Accredify Global issues |
| Medical devices | 21 CFR Part 820 (QMSR), ISO 13485 | FDA inspection; ISO 13485 certification for customers |
Who Needs GMP Readiness Support?
Most GMP projects start with an inspection on the horizon, a new market, or a customer audit request.
Contract manufacturers and brands preparing for FDA Part 111 inspections and retailer GMP audit requirements.
Sites preparing for regulatory inspection, or for a new export market that asks for GMP evidence.
Brands and fillers getting ready for MoCRA rules and ISO 22716 certification.
Facilities strengthening the GMP base that HACCP and ISO 22000 depend on.
Manufacturers aligning production controls with the FDA QMSR and ISO 13485.
Suppliers to regulated manufacturers who are audited against GMP before approval.
How to Get GMP Certification Ready
Six stages from first call to an inspection- or audit-ready site.
Not sure which GMP rules apply, or whether your batch records would stand up to an inspector? A free scoping review answers that first.
Book a free scoping reviewWhat Our GMP Readiness Work Improves
The outcomes quality and operations teams care about most.
We confirm which GMP requirements apply to each product and market before any work starts, so you don't prepare for the wrong inspection.
Gaps in hygiene, validation, and batch control are ranked by product risk, so the fixes that protect product quality come first.
Procedures, batch records, deviations, and training evidence organized the way inspectors and customer auditors review them.
For cosmetics, food, and medical devices, the same work carries into ISO 22716, ISO 22000, or ISO 13485 certification with Accredify Global.
GMP Certification Requirements: What Inspectors and Auditors Check
The details differ by sector, but these areas come up in almost every GMP inspection or audit.
Quality system & responsibilities
A quality unit with clear authority, written procedures, and management review of quality.
Personnel & hygiene
Training records, gowning and hygiene rules, and health reporting for production staff.
Premises & equipment
Suitable design, cleaning, maintenance, calibration, and equipment qualification.
Materials & suppliers
Supplier qualification, incoming inspection, specifications, and controlled storage.
Production & validation
Master and batch records, validated processes and cleaning, and in-process controls.
Quality control & complaints
Testing and release, deviations, CAPA, complaints, and recall readiness.
Documents inspectors commonly ask for
- Quality manual or site master file
- Standard operating procedures and their version history
- Master production and batch records
- Cleaning, process, and equipment validation records
- Supplier qualification and specifications
- Training records for each role
- Deviation, CAPA, and change control logs
- Complaint files and recall procedure
How to obtain GMP certification, by route
- Regulatory GMP — pass the authority's inspection; readiness work prepares you
- Customer or retailer GMP — pass the audit the buyer names; check their exact requirement
- ISO 22716 (cosmetics) — a certification audit by Accredify Global
- ISO 22000 or HACCP (food) — a certification audit by Accredify Global
Cost of GMP Certification Readiness and Timeline
There is no list price. The cost of GMP readiness follows your sector, sites, and how much remediation is needed. A free scoping review gives you a tailored proposal for your real scope.
What moves the cost
- Sector and rules — pharmaceutical GMP is deeper than food GMP
- Sites and lines — the number of facilities and production lines
- Validation — how much process and cleaning validation is missing
- Documentation — whether procedures and batch records exist
- Certification — whether an ISO certification audit follows
How long GMP readiness takes
| Typical readiness program | 6–12 weeks, depending on scope and maturity |
|---|---|
| Validation-heavy remediation | Longer, depending on what needs validating |
| ISO certification audit | Scheduled once records show the system in use |
GMP vs ISO 9001, ISO 22716, HACCP, and ISO 13485
GMP controls overlap with the ISO standards many manufacturers already hold. Here's how they relate.
| Standard | What it covers | How it relates to GMP |
|---|---|---|
| ISO 9001 | General quality management | A useful management base, but not a substitute for sector GMP rules. |
| ISO 22716 | Cosmetics GMP | The certifiable GMP standard for cosmetics manufacturing. |
| HACCP & ISO 22000 | Food safety | Built on GMP and hygiene programs, with hazard analysis on top. |
| ISO 13485 | Medical device quality management | The basis of the FDA QMSR for device manufacturers. |
| WHO GDP | Good distribution practice | Covers storage and transport after GMP manufacturing ends. |
How to Choose GMP Certification Services
The questions worth asking before you sign, and how Accredify Global answers them.
| Question to ask | Accredify Global's answer |
|---|---|
| Can you issue a GMP certificate? | For cosmetics (ISO 22716), food (ISO 22000, HACCP), and devices (ISO 13485), yes. For regulatory GMP, the authority decides; we prepare you. |
| Which GMP rules will you assess against? | The ones that apply to your products and markets, confirmed at scoping. |
| Will you visit the site? | Yes. GMP gaps are found on the production floor, not only in documents. |
| What do we get? | A prioritized remediation tracker, documentation support, and an audit-ready evidence pack. |
| How is it priced? | A tailored proposal after a free scoping review. |
Typical GMP Deliverables
Which GMP requirements apply to each product and market.
Findings from the site visit, ranked by product risk.
Hygiene, quality, supplier, and process-control actions with owners.
Support on procedures, batch records, and quality documentation.
An internal audit run the way an inspector would, with findings.
Procedures, records, and training evidence organized for review.
Frequently Asked Questions About GMP Certification
Straight answers on who certifies GMP, supplements, cost, timeline, and the ISO routes.
What is GMP certification?
GMP certification is evidence that a manufacturer follows Good Manufacturing Practice, the controls that keep products consistently made to their quality standard. Depending on sector and market, it comes from a regulator's inspection, a third-party audit, or a certifiable standard such as ISO 22716 for cosmetics.
What does GMP stand for?
GMP stands for Good Manufacturing Practice. In the US, FDA uses the term current Good Manufacturing Practice (cGMP) for its regulations, to signal that manufacturers should use up-to-date methods and technology.
Is there an official GMP certification?
There is no single GMP certificate. FDA enforces cGMP through inspections under sector rules. EU authorities inspect manufacturers and record GMP certificates in the EudraGMDP database. For cosmetics, ISO 22716 is a certifiable GMP standard.
Does FDA issue GMP certificates?
FDA enforces cGMP through inspections rather than issuing GMP certificates to manufacturers. The rules are 21 CFR Parts 210 and 211 for drugs, Part 111 for dietary supplements, Part 117 for food, and Part 820 for medical devices.
Is GMP certification mandatory?
Compliance with GMP is mandatory for regulated products such as drugs, dietary supplements, food, and medical devices in the US and EU. A certificate is often not legally required, but buyers and retailers frequently ask for a third-party GMP audit or certificate.
What is GMP certification for supplements?
US dietary supplement manufacturers must follow FDA's cGMP rule in 21 CFR Part 111, which FDA enforces by inspection. Many retailers and brands also require a third-party GMP audit or registration. Accredify Global prepares manufacturers for both.
How do I obtain GMP certification?
First confirm which GMP rules apply to your products and markets. Then close gaps in hygiene, validation, and records, and pass the relevant inspection or audit. For cosmetics, food, and medical devices, Accredify Global can also issue ISO 22716, ISO 22000, or ISO 13485 certificates.
What does GMP cover?
GMP commonly covers the quality system, personnel training and hygiene, premises and equipment, and materials and suppliers. It also covers production and validation, quality control, deviations and CAPA, complaints, traceability, and recalls.
How much does GMP certification cost?
The cost of GMP readiness depends on your sector, the number of sites and lines, and how much validation and documentation is missing. It also depends on whether an ISO certification audit follows. Accredify Global reviews your scope for free and sends a tailored proposal.
How long does GMP certification take?
Most Accredify Global GMP readiness programs take 6 to 12 weeks, depending on scope and maturity. Remediation that needs significant process or cleaning validation takes longer.
Does Accredify Global issue GMP certificates?
For cosmetics, Accredify Global issues ISO 22716 certificates, and for food and medical devices it issues ISO 22000, HACCP, and ISO 13485 certificates. For regulatory GMP, such as FDA cGMP, the authority decides through inspection, and Accredify Global prepares you.
What is ISO 22716?
ISO 22716 is the international Good Manufacturing Practice standard for cosmetics. It covers production, control, storage, and shipment of cosmetic products, and it can be independently certified.
Will the FDA require GMP for cosmetics?
The Modernization of Cosmetics Regulation Act (MoCRA) directs FDA to set GMP regulations for cosmetics. As of early 2026, final rules had not been issued. ISO 22716 is the common reference in the meantime.
What is the difference between GMP and ISO 9001?
ISO 9001 is a general quality management standard that applies to any organization. GMP rules are sector-specific and prescribe how regulated products must be made, controlled, and documented. ISO 9001 is a useful base but does not replace GMP.
Can GMP work be combined with ISO standards?
Yes. GMP controls align well with ISO 9001, ISO 22000, ISO 13485, and ISO 22716. One set of procedures and records can support both regulatory GMP and ISO certification.
What is the difference between GMP and GDP?
GMP covers how products are manufactured. Good Distribution Practice (GDP) covers how they are stored and transported after they leave the manufacturer, including temperature control and traceability.
Find Out Which GMP Rules Apply, and Where Your Site Stands
Tell us about your products, sites, and the inspection, market, or customer audit ahead. We'll confirm the applicable GMP requirements, recommend a timeline, and send a tailored proposal.
Book your free scoping review →