cGMP Certification in USA
Current Good Manufacturing Practice Certification, Manufacturing Quality Audits and FDA Regulatory Guidance
Current good manufacturing practices set the controls that help manufacturers make products consistently, under conditions suited to the product category. Third-party cGMP certification is an independent assessment against a clearly identified scheme or set of audit criteria.
Regulatory requirements depend on what you make. Food, dietary supplements, drugs, medical devices and cosmetics follow different FDA rules. A third-party certificate never replaces FDA inspection, registration, listing, clearance or approval, and FDA does not endorse IAS certificates.
Read this first
What cGMP certification is, and what it is not
FDA compliance and voluntary certification are different things. One manufacturer may also operate under more than one FDA framework.
Third-party cGMP certification is
- Voluntary Usually asked for by customers or contract givers.
- Criteria-based An audit against named certification criteria.
- Scoped Named sites, products and activities only.
- Sample-based Evidence sampled on the audit dates.
It is not
- FDA approval, clearance or endorsement
- FDA facility registration or product listing
- An FDA inspection
- US market access
- Product testing or batch release
- A licence to manufacture
- Proof of regulatory compliance
- A guarantee against recalls
Official FDA documents compared with third-party certificates
| Document | Issued by | What it is |
|---|---|---|
| cGMP declaration | FDA Center for Drug Evaluation and Research (CDER) | A letter sent to a foreign regulator on the cGMP status of an FDA-inspected US drug establishment, normally only when the regulator does not accept a Certificate of Pharmaceutical Product |
| Certificate of Pharmaceutical Product (CPP) | CDER | An export certificate for drug products in the format the WHO scheme uses |
| Food export certificates (for example Certificate to a Foreign Government) | FDA human foods program | Export attestations for foods; FDA states it does not issue cGMP certifications for food |
| Certificate of Free Sale for dietary supplements | FDA human foods program | An export certificate; FDA says it does not mean FDA found full compliance with the law |
| Device export certificates (for example Certificate to Foreign Government) | FDA Center for Devices and Radiological Health (CDRH) | Export attestations for devices; check CDRH for current types and conditions |
| Third-party cGMP certificate or declaration | A certification body such as IAS | A contractual, voluntary assessment result. Not an FDA document, approval or endorsement |
Official sources: FDA CDER: cGMP declarations (opens in a new tab) · FDA: food export certification FAQs (opens in a new tab). Last verified November 1, 2026.
GMP vs cGMP
Understanding good manufacturing practice and current good manufacturing practice
GMP covers suitable facilities, competent people, appropriate equipment, material control, written procedures, production records, quality control, contamination prevention, traceability, monitoring and corrective action. “Current” means keeping those controls suitable and aligned with current requirements. It does not mean buying the newest technology regardless of need.
Myth or fact? Select each statement.
- Myth. FDA cGMP requirements differ by product: Part 117 for food, Part 111 for dietary supplements, Parts 210 and 211 for drugs, Part 820 (QMSR) for devices. Cosmetics have no final FDA GMP regulation yet.
- Myth. “cGMP” is the US regulatory term. “Current” means practices must stay up to date with current requirements; it is not a separate grade.
- Myth. It means systems and controls must remain suitable and aligned with current expectations, not that every new technology is required.
- Myth. FDA inspects against its regulations. It issues some export-related documents, such as CDER cGMP declarations, but does not run a third-party style cGMP certification program.
- Fact. For example a site making both foods and dietary supplements, or drugs and devices, may fall under several regulations.
- Fact. Within its stated scope, criteria and dates, and without replacing any regulatory requirement.
Industry and regulatory pathway selector
Which cGMP requirements apply to your manufacturing business?
Four steps. The result is a starting point for review, not a legal determination. Borderline products need review of ingredients, intended use, claims and law before classification.
FDA food cGMP
Food manufacturing cGMP requirements — 21 CFR Part 117
Subpart B sets cGMPs. Preventive controls in Subpart C are related but separate, with exemptions and modified requirements. Not every food facility needs a third-party certificate, a cGMP certificate does not satisfy FSMA preventive controls, and food cGMP is not pharmaceutical GMP.
- Regulatory reference
- 21 CFR Part 117, Subpart B
- Product sector
- Human food and beverages
- Last verified
- November 1, 2026
- Official source
- eCFR: 21 CFR Part 117 (opens in a new tab)
Personnel (117.10)
Hygiene, disease control, clothing, education and training appropriate to the person’s duties.
Plant and grounds (117.20)
Grounds and plant construction that allow sanitary operations and prevent contamination.
Sanitary operations (117.35)
Cleaning and sanitizing, pest control and storage of cleaning chemicals.
Sanitary facilities and controls (117.37)
Water supply, plumbing, sewage, toilets, handwashing and waste.
Equipment and utensils (117.40)
Design, construction and maintenance that allow cleaning and prevent contamination.
Processes and controls (117.80)
Raw material handling, manufacturing operations and controls to prevent contamination, including allergen cross-contact.
Warehousing and distribution (117.93)
Storage and transport under conditions that protect food, including against allergen cross-contact.
Allergen cross-contact
Referenced throughout Subpart B since the FSMA amendments.
FDA: cGMPs for food and dietary supplements (opens in a new tab) · HACCP certification · ISO 22000 certification
Educational summary in our own words. Scope limitations: applicability depends on your products, activities and exemptions; check the current eCFR text and FDA guidance, and take qualified advice for decisions.
Dietary supplement cGMP
Dietary supplement manufacturing — 21 CFR Part 111
Part 111 covers manufacturing, packaging, labeling and holding of dietary supplements. Facilities complying with Part 111 are exempt from Part 117 Subparts C and G for those operations; dietary ingredient manufacturing generally falls under Part 117. Certification does not authorize therapeutic claims, supplements are not FDA-approved drugs, and a generic checklist does not demonstrate Part 111 compliance.
- Regulatory reference
- 21 CFR Part 111 (and relevant Part 117 provisions)
- Product sector
- Dietary supplements
- Last verified
- November 1, 2026
- Official source
- eCFR: 21 CFR Part 111 (opens in a new tab)
Personnel (Subpart B)
Qualified, trained and supervised personnel; hygiene requirements.
Physical plant (Subpart C)
Design, cleaning, sanitation and pest control.
Equipment (Subpart D)
Design, calibration, maintenance, cleaning and automated systems.
Production and process control (Subpart E)
Specifications for components, in-process, finished batches and labels; quality control.
Quality control (Subpart F)
Quality control personnel review, approve or reject.
Components, packaging and labels (Subpart G)
Receipt, identity testing, quarantine and release.
Master manufacturing record (Subpart H)
One for each unique formulation and batch size.
Batch production record (Subpart I)
Each batch, following the master record.
Laboratory operations (Subpart J)
Facilities, methods and controls for testing.
Manufacturing operations (Subpart K)
Contamination prevention and process control.
Packaging and labeling (Subpart L)
Label control and reconciliation.
Holding and distribution (Subpart M)
Storage conditions and reserve samples.
Returned supplements (Subpart N)
Quarantine, investigation and disposition.
Product complaints (Subpart O)
Review and investigation by qualified persons.
Records (Subpart P)
Retention and availability for inspection.
Points auditors look at closely
- Identity testing of each dietary ingredient
- Specifications for components, in-process and finished batches
- Quality control decisions to approve or reject
- Master manufacturing record per formulation and batch size
- Batch production records
- Label control and reconciliation
- Traceability and reserve samples
Educational summary in our own words. Scope limitations: applicability depends on your products, activities and exemptions; check the current eCFR text and FDA guidance, and take qualified advice for decisions.
Pharmaceutical cGMP
Pharmaceutical current good manufacturing practice — 21 CFR Parts 210 and 211
Topics include process validation, equipment qualification, cleaning validation, batch records, laboratory testing, deviation investigation, change control, data integrity, release, complaints and recalls. An IAS certificate does not approve a drug or substitute for FDA inspection, and food cGMP alone is not enough for drugs. No process parameters are given here.
- Regulatory reference
- 21 CFR Parts 210 and 211
- Product sector
- Finished pharmaceuticals (APIs follow cGMP under the FD&C Act and FDA guidance)
- Last verified
- November 1, 2026
- Official source
- eCFR: 21 CFR Part 211 (opens in a new tab)
Quality control unit (211.22)
Responsibility and authority to approve or reject components, products, procedures and specifications.
Personnel (Subpart B)
Education, training and experience for assigned functions; cGMP training.
Buildings and facilities (Subpart C)
Design, ventilation, lighting, plumbing, sanitation and maintenance.
Equipment (Subpart D)
Design, cleaning, maintenance, calibration and automated equipment.
Components, containers and closures (Subpart E)
Receipt, quarantine, testing, approval and storage.
Production and process controls (Subpart F)
Written procedures, deviations, in-process controls and process validation.
Packaging and labeling (Subpart G)
Label issuance, examination and reconciliation.
Holding and distribution (Subpart H)
Warehousing and distribution procedures.
Laboratory controls (Subpart I)
Specifications, testing, stability and reserve samples.
Records and reports (Subpart J)
Batch records, laboratory records, complaint files and annual product review.
Returned and salvaged drugs (Subpart K)
Evaluation and disposition.
FDA: cGMP regulations for drugs (opens in a new tab)
Educational summary in our own words. Scope limitations: applicability depends on your products, activities and exemptions; check the current eCFR text and FDA guidance, and take qualified advice for decisions.
Medical device QMSR
Medical device quality systems — FDA QMSR effective February 2, 2026
The former Quality System Regulation was replaced: since February 2, 2026, Part 820 is the Quality Management System Regulation, which incorporates ISO 13485:2016 by reference with FDA-specific requirements. ISO 13485 certification does not establish full QMSR compliance, and no third-party certificate provides FDA clearance or approval.
- Regulatory reference
- 21 CFR Part 820 (QMSR)
- Product sector
- Medical devices
- Last verified
- November 1, 2026
Part 820 (QMSR)
Incorporates ISO 13485:2016 by reference, with clause 3 of ISO 9000:2015 for terms.
FDA-specific requirements
Additional FDA provisions, for example on records and complaint files (820.35) and labeling and packaging; the Act and FDA regulations control where they conflict with ISO 13485.
Risk management
Required throughout the quality management system under ISO 13485 as incorporated.
Design and development
Applies where the manufacturer designs devices, including devices made under an IDE (820.10(c)).
Production and process controls
Including process validation where results cannot be fully verified.
Supplier management
Evaluation and control of suppliers according to risk.
Traceability
Records proportionate to the device, with additional expectations for implantable devices.
Complaints, nonconforming product and corrective action
As ISO 13485 requires, plus FDA reporting rules such as medical device reporting.
Inspections
FDA stopped using QSIT and inspects under Compliance Program 7382.850.
ISO 13485 certification · 510(k) submission support · eCFR: 21 CFR Part 820 (opens in a new tab)
Educational summary in our own words. Scope limitations: applicability depends on your products, activities and exemptions; check the current eCFR text and FDA guidance, and take qualified advice for decisions.
Cosmetics and MoCRA
Cosmetics manufacturing quality and current US requirements
Registration is not approval, FDA does not issue routine registration compliance certificates, and a third-party cosmetics GMP certificate does not show that MoCRA requirements are met. Guidance is not binding regulation.
- Regulatory reference
- FD&C Act as amended by MoCRA; FDA cosmetics GMP guidance (non-binding)
- Product sector
- Cosmetics and personal care
- Last verified
- November 1, 2026
- Official source
- FDA: MoCRA (opens in a new tab)
Facility registration
Facilities that manufacture or process cosmetics for US distribution register with FDA and renew every two years, unless exempt.
Product listing
Responsible persons list each cosmetic product and keep listings updated, unless exempt.
Safety substantiation
Responsible persons keep records showing adequate substantiation of safety.
Adverse event reporting
Serious adverse events reported to FDA within the statutory time.
Mandatory recall authority
FDA has recall authority under MoCRA; its Q&A guidance was issued in draft in December 2025.
GMP regulations
MoCRA requires FDA to issue GMP regulations. As of November 1, 2026 no final rule has been issued; the proposed rule was moved to FDA’s long-term actions list. FDA’s cosmetics GMP guidelines and checklist are non-binding guidance.
Manufacturing hygiene themes
Raw material control, water quality, equipment cleaning, contamination prevention, packaging and labeling, complaints and records.
Drug-cosmetics
Products with drug claims, such as sunscreens, are also drugs and subject to drug cGMP.
FDA: Cosmetics GMP guidelines and inspection checklist (opens in a new tab)
Educational summary in our own words. Scope limitations: applicability depends on your products, activities and exemptions; check the current eCFR text and FDA guidance, and take qualified advice for decisions.
Contract manufacturing
Managing cGMP responsibilities between brand owners and contract manufacturers
A fictional relationship: brand owner → contract manufacturer → testing laboratory → packaging supplier. A quality agreement allocates tasks but does not remove statutory responsibilities, and a contract manufacturer’s certificate does not certify the brand owner.
Scope builder
Define your cGMP certification scope
A preliminary summary for technical review. It does not approve classification, set audit duration, certify every product at a site or assume any scheme fits every facility.
Quality system explorer
The core elements of effective cGMP manufacturing
Twelve areas. Requirements differ by sector, so each shows the regulatory context and a fictional example.
Batch traceability explorer
Trace a product batch from raw materials to finished goods
All data is fictional. This is not a validated production system, it makes no release decisions, and batch record requirements differ by industry.
Personnel
Why competent manufacturing personnel matter
Qualifications, training, hygiene, responsibilities, training effectiveness, task authorization, supervision and records. An attendance sheet does not always show competence, and an IAS or EAS course certificate does not replace professional or regulatory qualifications.
Facilities
Manufacturing facilities and contamination prevention
Layout, flows, segregation, hygiene, cleaning, pest control, water, ventilation, temperature, humidity, environmental monitoring where applicable, waste and maintenance. No universal cleanroom grade applies; food and cosmetics plants do not need pharmaceutical cleanrooms unless the product and process require them.
Equipment
Managing manufacturing equipment throughout its lifecycle
Formal IQ/OQ/PQ is not mandatory for every food machine, and maintenance alone does not validate a process.
Process validation
Understanding manufacturing process validation
Process definition, critical characteristics, acceptance criteria, verification, validation where required, monitoring, revalidation triggers, change control and records. No universal protocols, sample sizes or acceptance criteria apply, and IAS does not write validation protocols for clients it certifies.
| Sector | General expectation |
|---|---|
| Pharmaceutical drugs | Process validation is expected under Parts 210 and 211, following FDA’s process validation guidance; cleaning validation where needed. |
| Medical devices | Process validation where results cannot be fully verified by later inspection and test, under ISO 13485 as incorporated in the QMSR. |
| Dietary supplements | Part 111 requires specifications and verification that they are met; it does not use the drug process validation model in the same way. |
| Food | Part 117 Subpart B focuses on sanitary controls; validation applies to certain preventive controls under Subpart C. |
| Cosmetics | No final FDA GMP rule; validation expectations come from guidance, customers and voluntary standards. |
- Validation
- Evidence that a process consistently produces results meeting predetermined requirements.
- Verification
- Confirmation, by examination or test, that a specific output met requirements.
Documentation and data integrity
Manufacturing documentation that supports reliable quality decisions
SOPs, document control, master and batch records, logs, training, test, change, deviation and CAPA records, electronic records, audit trails and retention. ALCOA+ is a widely used data integrity concept, not a regulatory certification scheme. Electronic records for drugs and devices are also subject to 21 CFR Part 11 where it applies.
Materials and suppliers
Controlling materials before they enter manufacturing
Supplier certificates alone do not establish suitability, identity requirements differ by sector, and this tool approves no real material lot.
Deviation and CAPA
Managing manufacturing deviations and corrective actions
A fictional deviation involving an unexpected equipment condition. Product disposition is never decided here, escalation and reporting differ, and nothing here overrides a pharmaceutical quality unit.
Change control
Managing changes without compromising product quality
Changes do not all need the same approval. Some need regulatory submissions, notifications or approvals; this page does not decide reportability.
Quality control and release
How manufacturers evaluate product quality
A certification audit does not approve batches, and voluntary certification does not replace required testing and release procedures.
- Incoming materials Evaluated before use.
- In-process controls Checks during manufacture.
- Laboratory testing Against specifications, with out-of-specification investigation.
- Batch review Complete records, closed deviations.
- Nonconforming product Segregated and evaluated.
- Release authority The quality unit or quality control function the regulation names.
- Finished product records Kept for the required period.
Complaints, returns and recalls
Managing product quality issues after distribution
Complaint intake, investigation, batch linkage, returns, quality defects, recall assessment, traceability, communication, records and corrective action. A certificate does not prevent recalls, and this page does not decide whether a recall or report is legally required.
- Receive Log the complaint with product and lot.
- Link Find the batch and its records.
- Investigate Retained samples, records, trends.
- Assess Health risk and regulatory duties.
- Scope Trace affected batches and customers.
- Act Recall or correction as decided by the responsible firm, with regulators where required.
- Prevent Corrective action and effectiveness check.
Compared
Understanding the difference between FDA inspection and independent certification
An IAS audit is not an FDA inspection, an IAS certificate is not an FDA compliance determination, and passing a third-party audit does not predict a future FDA inspection.
| FDA inspection | Independent cGMP certification audit | |
|---|---|---|
| Authority | Federal law (the FD&C Act and FDA regulations) | Contract between the manufacturer and the certification body |
| Objective | Determine compliance with FDA requirements | Assess against stated certification criteria |
| Applicable rules | The FDA regulations for the product | The scheme’s criteria, which may reference regulations |
| Assessment criteria | FDA regulations and compliance programs | Certification scheme criteria |
| Inspection rights | Statutory; refusal has legal consequences | Contractual access agreed by the client |
| Findings | Inspectional observations may be listed on Form FDA 483; a 483 is not a final agency determination | Nonconformities graded by the scheme |
| Decision | FDA decides on regulatory action | Independent certification decision by the certification body |
| Enforcement | Warning letters, import alerts, seizure, injunction and other actions | Suspension or withdrawal of certification only |
| Resulting document | Inspection records; Establishment Inspection Report available through FOIA processes | Certificate or declaration with scope and dates |
| Agency endorsement | It is the agency | None; not an FDA endorsement |
| Limits | Covers what FDA inspected | Sample-based; does not predict a future FDA inspection |
Choosing a framework
Which manufacturing quality framework does your business need?
One framework does not replace another. ISO 9001 does not show pharmaceutical cGMP compliance, ISO 13485 is not FDA clearance, and HACCP certification does not satisfy FDA preventive controls.
| cGMP | HACCP | ISO 9001 | ISO 13485 | ISO 22000 | |
|---|---|---|---|---|---|
| Purpose | Manufacturing controls required for the product | Preventive control of significant food safety hazards | Generic quality management | Device quality management | Food safety management |
| Product sector | Depends on the regulation | Food | Any | Medical devices | Food chain |
| Governing authority | FDA regulations by sector | Codex principles; FDA and USDA for regulated sectors | ISO | ISO; incorporated in FDA’s QMSR | ISO |
| Scope | Manufacturing, packaging, holding and testing | Hazards in a defined process | Organization-wide QMS | Device QMS | Food safety management system |
| Regulatory status | Mandatory where the regulation applies | Mandatory in some sectors; voluntary elsewhere | Voluntary | Voluntary certification; QMSR is mandatory for US device makers | Voluntary |
| Audit type | FDA inspection; voluntary third-party audit | Regulatory inspection or voluntary audit | Accredited certification audit | Accredited certification audit; FDA inspection under QMSR | Accredited certification audit |
| Certificate | Third-party certificate or declaration is voluntary | Scheme-dependent | ISO 9001 certificate | ISO 13485 certificate (not FDA clearance) | ISO 22000 certificate |
| Typical evidence | Batch records, cleaning, QC, training | Hazard analysis, CCP monitoring | Processes, objectives, audits | Design, risk, production, complaints | Hazard analysis, PRPs, monitoring |
| Limitations | Does not replace FDA requirements | Not drug or device GMP | Does not prove drug or device cGMP | Does not establish full QMSR compliance or clearance | Not GFSI-recognized by itself |
ISO 9001 · ISO 13485 · HACCP · ISO 22000 · FSSC 22000
Readiness check
Is your manufacturing quality system prepared for cGMP assessment?
23 general questions plus sector questions. No personal details. Educational only: not an FDA compliance audit, a legal determination or a certification guarantee.
Certification process
How to obtain voluntary cGMP certification in the USA
Thirteen typical steps. Stage 1/Stage 2 audits, annual surveillance or a fixed cycle apply only if the confirmed scheme says so. IAS makes no FDA regulatory decisions.
Audit methods
How cGMP manufacturing audits are conducted
Remote technology can support some activities if the scheme allows. Fully remote certification is not promised, a video tour does not replace observation where a site visit is required, and auditors do not test your batches.
| Activity | Remote suitability | What it shows |
|---|---|---|
| Documentation review | Often possible remotely | Procedures, master records, specifications |
| Personnel interviews | Possible remotely in part | Understanding of tasks and responsibilities |
| Production area observation | Requires presence | Practices, hygiene, flows, status |
| Batch record sampling | Remote or on site | Completeness and attribution |
| Traceability exercises | Remote or on site, timed | Ability to link materials, batches and customers |
| Equipment review | Mostly on site | Status, logbooks, calibration |
| Material storage | On site | Segregation, status, conditions |
| Cleaning and sanitation | On site | Practices and verification |
| Laboratory controls | Mostly on site | Methods, records, OOS handling |
| Corrective action review | Remote or on site | Investigations and effectiveness |
Audit evidence
Strong vs weak cGMP audit evidence
Illustrative comparisons, not measured IAS audit trends.
| Area | Strong | Weak |
|---|---|---|
| Batch records | StrongComplete and attributable manufacturing records | WeakMissing entries or retrospective records |
| Cleaning | StrongDocumented cleaning with appropriate verification | WeakAn unverified statement that equipment was cleaned |
| Training | StrongRole-specific competence evidence | WeakAttendance records without evaluation |
| Equipment | StrongMaintenance, calibration and qualification evidence | WeakUnclear equipment status |
| Supplier controls | StrongQualification and material acceptance records | WeakUnsupported supplier claims |
| CAPA | StrongDocumented investigation and effectiveness review | WeakRepeated problems without follow-up |
| Change control | StrongReview before implementation | WeakUncontrolled manufacturing changes |
Cost factors
How much does cGMP certification cost in the USA?
No prices, fixed audit days, eight-week issuance or 24-hour report promises. Quotations come from technical review under the confirmed scheme.
Scheme and accreditation
Understanding IAS cGMP certification and its recognition
The live page says IAS is accredited by UQAS and issues cGMP certificates. These items must be confirmed, sector by sector, before quotations are offered.
| Item | What we found | Status |
|---|---|---|
| 1. Exact legal certification entity | Integrated Assessment Services LLC on the site. Confirm the name on the document. | Confirm |
| 2. Actual GMP certification scheme | The live page says “cGMP criteria” without naming a scheme or criteria document. | Not verified |
| 3. Scheme owner | Not stated. | Not verified |
| 4. Certification criteria | Not published. | Not verified |
| 5. Relevant product sectors | The live page lists food, pharma, cosmetics, supplements and devices; sector authorization not documented. | Not verified |
| 6. Accreditation body | The live page says IAS is accredited by UQAS. | Confirm |
| 7. Current accreditation certificate | UQAS codes MS/56891 and PC/76892 are referenced on the IAS site; certificate not reviewed for cGMP. | Confirm |
| 8. Exact scheme accreditation scope | cGMP and each sector not confirmed in the scope. | Not verified |
| 9. Conformity assessment standard | ISO/IEC 17065 or ISO/IEC 17021-1 basis not stated. | Not verified |
| 10. Auditor sector competence | Sector competence criteria not published. | Not verified |
| 11. Certificate-issuing entity | IAS under UQAS. For Part 111 work IAS issues a Declaration of Conformity under UQAS rather than a certificate. | Confirm |
| 12. Certificate validity | The live diagram shows annual surveillance and recertification in year four; scheme rule unconfirmed. | Not verified |
| 13. Surveillance requirements | Not published as scheme rules. | Not verified |
| 14. Authorized marks | The live page refers to a published logo guideline. | Confirm |
| 15. Recognition arrangements | None claimed. UQAS is not an FDA recognition and not IAF MLA. | Not claimed |
| 16. Certificate verification URL | IAS certificate search. Open certificate search (opens in a new tab) | Available |
- FDA
- UQAS accreditation does not provide FDA recognition, and IAS is not FDA-accredited.
- Sectors
- One accreditation scope does not automatically cover every GMP sector.
- EAS
- EAS’s JAS-ANZ accreditation belongs to EAS, not IAS.
- Acceptance
- Generic GMP certification is not universally accepted by FDA, foreign regulators or customers.
IAS status: scheme and sector scope not yet verified. No quotation is offered on this page until they are.
Impartiality
Independent manufacturing quality assessment
- Competence Auditors with sector knowledge.
- Impartiality and conflicts Managed and recorded.
- Confidentiality Client information protected.
- Evidence-based Conclusions from records, observation and interviews.
- No consultancy IAS does not write SOPs, batch records, CAPA systems or validation protocols for clients it certifies.
- Independent decisions By people not involved in the audit.
- Complaints and appeals Through a documented process.
- Training is separate Attending IAS or EAS training does not lead to certification.
Why IAS USA
Why manufacturers consider IAS USA
Documented facts only. No client counts, success rates, recall statistics or testimonials are claimed.
- Accredited certification body IAS is accredited by UQAS; sector scope for cGMP is being confirmed.
- Clear scope assessment Sites, products and activities named before any proposal.
- Structured procedures Application review, audit, independent decision and surveillance as the scheme sets.
- Combined audits ISO 9001, ISO 13485, ISO 22000 and HACCP can be planned alongside where schemes allow.
- Dallas office 1341 W Mockingbird Ln, Suite 600W, Dallas, TX 75247.
- Certificate search IAS certificate search (opens in a new tab)
Enquiry
Request your cGMP certification proposal
While the scheme and sector scope are being verified, certification requests receive the scheme details first, not a quotation.
- A business coordinator and a sector-qualified technical reviewer review your enquiry.
- IAS confirms the scheme, sector scope, issuer and accreditation in writing.
- Scope, audit days and fees are never approved automatically.
- Phone
- +1 (888) 493-0916
FAQ
cGMP questions
59 answers for US manufacturers. Sector rules vary; check the official sources.
What is cGMP?
Current Good Manufacturing Practice: the US term for manufacturing quality requirements FDA sets for regulated products, which differ by product sector.
What does cGMP stand for?
Current Good Manufacturing Practice.
What is the difference between GMP and cGMP?
They describe the same idea. “Current” stresses that practices must stay up to date with current requirements. They are not two certification grades.
Is cGMP one universal ISO standard?
No. FDA cGMP requirements are in separate regulations for food, dietary supplements, drugs and devices. ISO standards such as ISO 22716 for cosmetics GMP are separate voluntary documents.
Is cGMP certification mandatory in the USA?
No. Third-party cGMP certification is voluntary. Customers may require it by contract.
Are cGMP requirements mandatory for manufacturers?
Where an FDA cGMP regulation applies to your product and activity, compliance is mandatory whether or not you hold any certificate.
Does FDA issue GMP certificates?
Not as a third-party style certification. FDA issues some export documents: CDER sends cGMP declarations to foreign regulators for inspected US drug establishments and issues Certificates of Pharmaceutical Product, and other centers issue export certificates. FDA states it does not issue cGMP certifications for food.
Does FDA approve third-party cGMP certification bodies?
No. FDA does not approve certification bodies for voluntary cGMP certification.
Is a cGMP certificate equivalent to FDA approval?
No. It does not approve, clear or authorize any product.
Is FDA facility registration the same as certification?
No. Registration informs FDA of a facility. It is not approval or certification.
What are the cGMP requirements for food manufacturers?
21 CFR Part 117 Subpart B covers personnel, plant and grounds, sanitary operations and facilities, equipment, processes and controls, and warehousing and distribution.
What is 21 CFR Part 117?
FDA’s rule for human food: cGMPs (Subpart B) and hazard analysis and risk-based preventive controls (Subpart C), with exemptions and modified requirements.
What is 21 CFR Part 111?
FDA’s cGMP rule for manufacturing, packaging, labeling and holding dietary supplements.
Do dietary supplement manufacturers need cGMP controls?
Yes, under Part 111 for covered operations. Dietary ingredient manufacturing is generally under Part 117.
What are pharmaceutical cGMP requirements?
21 CFR Parts 210 and 211 for finished drugs, plus other applicable rules and guidance; API manufacture follows cGMP under the FD&C Act, with FDA guidance (ICH Q7).
What are 21 CFR Parts 210 and 211?
Part 210 sets general provisions; Part 211 sets cGMP for finished pharmaceuticals, from the quality control unit to records and returned drugs.
What is FDA QMSR?
The Quality Management System Regulation, 21 CFR Part 820, which incorporates ISO 13485:2016 by reference with FDA-specific requirements.
When did FDA QMSR become effective?
February 2, 2026.
Does ISO 13485 certification establish FDA QMSR compliance?
No. The QMSR adds FDA-specific requirements, and FDA determines compliance through its own inspections.
What GMP requirements apply to cosmetics?
As of November 1, 2026 FDA has not issued final cosmetics GMP regulations under MoCRA. Its GMP guidelines are non-binding. Cosmetics must not be adulterated, and drug-cosmetics also follow drug cGMP.
What is MoCRA?
The Modernization of Cosmetics Regulation Act of 2022, which added facility registration, product listing, safety substantiation, adverse event reporting, mandatory recall authority and a requirement for GMP regulations.
Does cosmetics registration mean FDA approval?
No.
Can contract manufacturers obtain GMP certification?
Yes, where the scheme covers their activities. Their certificate does not certify the brand owner.
Does certification cover every manufacturing site?
Only the sites named in the scope.
What is a certification scope?
The sites, products, activities and criteria a certificate covers.
What are batch manufacturing records?
Records of how each batch was made, following the approved master instructions.
What is material traceability?
The ability to link material lots to batches and batches to customers.
What is equipment qualification?
Documented evidence that equipment is installed and works as intended, common for drugs and devices.
What is process validation?
Evidence that a process consistently produces product meeting requirements, expected for drugs and for device processes that cannot be fully verified.
What is cleaning validation?
Evidence that a cleaning procedure consistently removes residues to acceptable levels. Cleaning verification checks a particular clean.
What is data integrity?
Records that are complete, consistent and accurate throughout their life.
What is ALCOA+?
A widely used set of data integrity principles: attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring and available. It is a concept, not a certification scheme.
What is deviation management?
Recording, investigating and resolving departures from approved instructions or specifications.
What is CAPA?
Corrective and preventive action: finding causes and preventing recurrence, then checking effectiveness.
What is change control?
Evaluating and approving changes before they are implemented.
What are supplier controls?
Qualifying, approving and monitoring suppliers and the materials they provide.
What is the difference between product testing and cGMP auditing?
Testing measures product samples. An audit examines the manufacturing system. Auditors do not test your batches.
What is the difference between cGMP and HACCP?
cGMP sets broad manufacturing controls; HACCP targets significant food safety hazards at control points.
What is the difference between cGMP and ISO 9001?
ISO 9001 is a generic quality management standard. It does not cover sector-specific cGMP requirements.
Can GMP and ISO 13485 be combined?
Audits can sometimes be combined where schemes allow; each keeps its own criteria.
Can cGMP audits be remote?
Some activities, such as document review, can be. Production observation usually needs a site visit.
Is a manufacturing facility visit required?
Usually, depending on the scheme.
What documents are required?
Scope, procedures, master and batch records, specifications, training, equipment, supplier, cleaning, deviation, CAPA, complaint and recall records, depending on the sector.
What happens during a cGMP audit?
Document review, interviews, floor observation, batch record sampling and traceability exercises against the criteria.
How much does certification cost?
It depends on sector, scheme, sites, lines, employees and travel. No prices are published here.
How long does certification take?
It depends on readiness and scheduling. No fixed timeline is promised.
How long is a cGMP certificate valid?
It depends on the scheme. No universal validity applies.
Are annual surveillance audits mandatory?
Only if the scheme requires them.
Can a GMP certificate be transferred?
Only if the scheme and both certification bodies allow it.
Who issues the IAS certificate?
IAS under UQAS accreditation. The exact document name, scheme and sector scope are being confirmed.
Is IAS cGMP certification accredited?
IAS is accredited by UQAS. Whether cGMP and each sector are within that accreditation scope is not yet verified.
Does a UQAS-accredited certificate guarantee FDA acceptance?
No. FDA does not recognize third-party cGMP certificates as compliance.
Can a GMP certificate be used for exports?
Some buyers may accept it. Foreign regulators often require official FDA export documents instead.
What are FDA export-related cGMP declarations?
Letters CDER sends to a foreign regulator on the cGMP status of an FDA-inspected US drug establishment, normally only when a Certificate of Pharmaceutical Product is not accepted.
Does the certificate guarantee product safety?
No. It reflects sampled evidence on audit dates.
How do I verify an IAS cGMP certificate?
Use the IAS certificate search and check scope, status and dates.
Is employee GMP training mandatory?
Training appropriate to duties is required under FDA cGMP rules where they apply.
Does GMP training certify the manufacturer?
No. Training educates people; certification is a separate audit.
How can I submit a quotation request?
Use the enquiry form. IAS confirms the scheme and sector scope before any quotation.
Related services and training
Official sources first.
- FDA: food and supplement cGMPs (opens in a new tab)
- FDA: drug cGMP (opens in a new tab)
- FDA: QMSR (opens in a new tab)
- FDA: MoCRA (opens in a new tab)
- GMP training
- cGMP internal auditor training
- ISO 13485 certification
- Product certification
- System certification
- Certification process
- Accreditation
- Foundation training
- Contact IAS USA
- Product certification procedure
- About us
- ISO certification bodies (blog)
- Course or service brochure (PDF)
- ISO 27001 certification
- Fda certification
- ISO 17025 certification
- ISO audit procedure
- ISO 14001 certification
- ISO 45001 certification
- ISO 9001 internal auditor training
- ISO 9001 lead auditor training
- ISO training
- Training schedule
- ISO certification
- Guideline for usage of logos
- Frequently asked questions
- IAS blog