Demonstrate your cosmetics GMP compliance in weeks, not months.
The ISO 22716 package is for any company subject to FDA cosmetics requirements (including MoCRA 2022) and/or to EU Regulation 1223/2009, regardless of size or position in the value chain.
Integrated production sites or contract manufacturers (CMs / co-mans) producing, filling, packaging, or storing cosmetic products for their own brand or for third-party brands. MoCRA-required facility registration applies.
Cosmetics brands that outsource production but retain regulatory responsibility (Responsible Person under MoCRA / EU). Indie and D2C startups launching on Amazon, Shopify, Sephora, Ulta, Target, Walmart that must structure GMP from day one.
Quality control labs, microbiology testing labs, specialized subcontractors (filling, packaging, formulation) who must demonstrate GMP compliance to brands, retailers, and regulators.
Cosmetics quality consultants and regulatory firms who want a validated documentation foundation to start client engagements quickly (consultant license available on request).
ISO 22716 contains 15 normative chapters (chapters 3 to 17). Each requires written procedures, traceable records, and evidence of operational implementation. Building all this in-house takes 4 to 8 months of writing work and exposes you to avoidable findings on audit day.
Most online templates are derivatives of ISO 9001 adapted at the margins. They ignore cosmetics-specific requirements: downstream traceability for recall, batch release, batch labeling, retention samples, allergen management, MoCRA Adverse Event reporting.
The Modernization of Cosmetics Regulation Act (MoCRA, December 2022) is the largest expansion of FDA cosmetics authority in 80+ years. It mandates facility registration, product listing, Adverse Event reporting, GMP compliance, fragrance allergen labeling, and grants FDA mandatory recall authority. FDA inspections of cosmetics facilities are increasing in frequency and depth.
Sephora, Ulta, Target, Walmart, Amazon (Premium Beauty), Costco, and major beauty conglomerates now require ISO 22716 attestation in their vendor onboarding. EU contract manufacturers also require it for any US brand exporting to Europe. Without a ready dossier, vendor qualification stalls.
A complete cosmetics GMP implementation engagement billed by a specialized firm represents 15 to 40 days of intervention. The documentation package gives you the complete written foundation — you keep your budget for field implementation and team training.
The package covers the 15 normative chapters of ISO 22716 plus the obligations of FDA cosmetics + MoCRA 2022 (facility registration, product listing, Adverse Event reporting, fragrance allergen labeling, mandatory recall) and EU Regulation 1223/2009 (PIF, CPNP notification, labeling, allergens, cosmetovigilance).
ISO 22716 is recognized worldwide as the cosmetics GMP reference standard. In the US, it is the de facto baseline that FDA inspectors look for under MoCRA, and that retailers (Sephora, Ulta, Target, Walmart, Costco, Amazon Premium Beauty) and EU contract manufacturers require for vendor onboarding. Below is the clause-by-clause mapping between the standard and the documents provided — this is what an auditor or buyer expects to see first.
| Chapter | ISO 22716 requirement | Documents provided in the package |
|---|---|---|
| 3.1 — 3.6 | Personnel: organization chart, responsibilities, training, hygiene, health, visitors | Hygiene & gowning procedure GMP training plan Job qualification record Visitor register Personnel health |
| 4.1 — 4.13 | Premises: design, zoning, cleaning, maintenance, pest control, ventilation | Zoning plan Cleaning & sanitization procedure Pest control plan Microbiological monitoring Premises maintenance |
| 5.1 — 5.9 | Equipment: design, installation, calibration, cleaning, maintenance, authorizations | IQ/OQ/PQ qualification Calibration plan Preventive maintenance Cleaning validation Equipment logbook |
| 6.1 — 6.8 | Raw materials & packaging materials: purchasing, receiving, identification, release, re-evaluation, water | Receiving & inspection procedure Supplier qualification Supplier specifications RM specifications RM status management Water qualification |
| 7.1 — 7.3 | Production: manufacturing operations, batch identification, in-process controls, packaging | Master batch record (MBR) Operations management Batch production record (BPR) Batch traceability WIP management |
| 8.1 — 8.5 | Finished products: release, storage, shipping, returns | Batch release FP specifications CoA template Storage & shipping Returns management |
| 9.1 — 9.8 | Quality control laboratory: methods, sampling, OOS, reagents, retention samples | Raw material QC Finished product QC Test methods (USP-aligned) OOS management Retention samples |
| 10.1 — 10.2 | Treatment of out-of-spec products: identification, isolation, decision, reprocessing | NC management NC processing record CAPA NC register |
| 11.1 — 11.5 | Wastes: types, flows, containers, compliant disposal, traceability | Waste management Waste tracking record Disposal plan |
| 12.1 — 12.5 | Subcontracting: written contract, evaluation, sharing of responsibilities | Subcontracting procedure Quality Agreement template Subcontractor specifications Evaluation grid |
| 13.1 — 13.2 | Deviations: deviation authorization, corrective action, recurrence prevention | Deviations procedure Deviation authorization form Deviations register |
| 14.1 — 14.3 | Complaints & recalls: registration, investigation, recall plan, regulator notification | Customer complaints Standard complaint form Batch recall (FDA + voluntary) Crisis communication Adverse Event reporting (MoCRA) |
| 15 | Change control: impact assessment, approval, traceability | Change control Change request form Modifications register |
| 16.1 — 16.3 | Internal audit: program, competent auditors, report, follow-up | Internal audit procedure Annual audit plan Audit checklist Chap. 3-17 Standard report template Findings tracking plan |
| 17.1 — 17.5 | Documentation: structure, approval, distribution, revision, archiving | Cosmetics GMP quality manual Document control Records management Master document list GMP glossary (Chap. 2) |
| FDA / MoCRA 2022 | US regulatory requirements: facility registration (Section 607, biennial), product listing (Section 607), Adverse Event reporting (Section 605, 6-year retention), Responsible Person designation (Section 605), safety substantiation (Section 608), fragrance allergen labeling (Section 612), mandatory recall (Section 611) | Facility registration procedure Product listing procedure Adverse Event reporting Responsible Person designation Safety substantiation file Fragrance allergen labeling Mandatory recall response |
| EU Regulation 1223/2009 | EU regulatory requirements (for export): PIF / Product Information File (Art. 11), CPNP notification (Art. 13), labeling (Art. 19), allergens (Annex III), cosmetovigilance (Art. 23) | PIF procedure CPNP notification procedure Compliant labeling Allergens Cosmetovigilance Mapping matrix |
| Not included | Documents specific to each product and each formula — which must be drafted case by case by your team, your safety assessor, or your Responsible Person | Complete PIF (per product) FDA product listing entries (per SKU) Filled-in safety substantiation (Section 608, MoCRA) Cosmetic Product Safety Report (per product, EU Art. 10) Manufacturing formulas Detailed manufacturing instructions (per product) Finished product technical data sheets (per SKU) Filled-in CPNP notifications (per product, EU) |
Beyond the clause-by-clause mapping, here are the technical rigor points that experienced Responsible Persons, Quality Directors, FDA inspectors, and safety assessors verify first.
ISO 22716 is recognized as the global cosmetics GMP standard by FDA (de facto baseline under MoCRA), the EU (Decision 2013/674/EU), and many international authorities. An ISO 22716-compliant package positions you for export and for global retailer requirements.
| Criterion |
QSE Academy ISO 22716 $589 |
Free templates $0 |
Cosmetics consulting firm $10,000 — $25,000 |
|---|---|---|---|
| Cosmetics-specific (not generic ISO 9001) | ✓ | ✗ | ✓ |
| Coverage of the 15 ISO 22716 chapters | ✓ 100% | Partial | ✓ 100% |
| FDA / MoCRA compliance procedures (registration, AE reporting, recall) | ✓ Included | ✗ | Per engagement |
| EU 1223/2009 compliance (PIF, CPNP, labeling) for export | ✓ Included | ✗ | Per engagement |
| Clause-by-clause mapping | ✓ Excel matrix | ✗ | Per engagement |
| Editable Word format, neutral charter | ✓ | Variable | ✓ |
| Delivery time | Instant | Instant | 4 to 8 months |
| Money-back guarantee | ✓ 30 days | ✗ | ✗ |
| Field implementation & team training | On you | On you | Included |
Answer the 14 questions chapter by chapter to get your ISO 22716 + FDA / MoCRA maturity score. Instant result, free, no personal information required.
The package isn't just delivered. Here is the concrete path to bring it into production in your facility, step by step.
Secure payment, immediate access to the full package as a ZIP. Within minutes you have the 121 Word documents, the ISO 22716 ↔ FDA / MoCRA ↔ EU mapping matrix, and the user manual.
Adapting the documents to your facility: logo, organizational chart, real process map, equipment, suppliers, MoCRA Responsible Person, applicable jurisdictions (US, EU export). Plan 2 to 4 weeks for thorough customization.
Team training (GMP, hygiene, batch records), MoCRA facility registration and product listing, IQ/OQ/PQ qualifications, cleaning validation, mock recall, internal audit. Records start feeding real GMP traceability.
Internal audit using the ISO 22716 checklist provided in the package. Identification of remaining gaps, corrective action plan, preparation for FDA inspection, retailer audits (Sephora, Ulta, Target, Walmart), or EU contract manufacturer qualification.
You have 30 days to download the package, review its content, open the documents, and verify that the writing quality matches your expectations. If something is off, you write us an email — no justification needed — and the refund is processed within 5 business days. That simple.
The cosmetics regulatory landscape evolves rapidly — especially with MoCRA implementation in the US. The package you buy today shouldn't become obsolete in 6 months. That's why updates are included.
The package already integrates ISO 22716:2007, FDA cosmetics regulations, MoCRA 2022 requirements (facility registration, product listing, AE reporting, fragrance allergen labeling, mandatory recall), and EU Regulation 1223/2009. In case of FDA final rules, MoCRA implementing guidance, EU Annex updates, or significant case law, you receive package updates free of charge for 12 months after your purchase.
The package gives you the complete documentation foundation required by ISO 22716 and FDA cosmetics regulations (including MoCRA). To pass an FDA inspection or a major retailer audit (Sephora, Ulta, Target, Walmart, Costco, Amazon Premium Beauty), you also need to fill in the documents with your real data (master batch records, product files, supplier contracts) and demonstrate operational implementation. The package saves you the 4 to 8 months of writing work. Operational implementation remains your work (typically 8 to 16 weeks depending on company size).
Yes. The package includes dedicated procedures for all MoCRA 2022 requirements: facility registration (Section 607, biennial), product listing (Section 607), Adverse Event reporting (Section 605, Serious AEs within 15 business days, 6-year recordkeeping), Responsible Person designation (Section 605), safety substantiation (Section 608), fragrance allergen labeling (Section 612), mandatory recall response (Section 611), and good manufacturing practice compliance (Section 606 — FDA final GMP rule expected, ISO 22716 is the de facto baseline).
ISO 22716 is not directly mandated by federal law in the US, but it is the de facto baseline that FDA inspectors look for under MoCRA. FDA published a draft GMP guidance based on ISO 22716 principles, and the final FDA GMP rule expected under MoCRA Section 606 is anticipated to align closely with ISO 22716. Major US retailers (Sephora, Ulta, Target, Walmart, Costco, Amazon) require ISO 22716 attestation in vendor onboarding. Foreign contract manufacturers serving the US market are inspected against ISO 22716 standards.
Most free templates are derivatives of ISO 9001 adapted at the margins. They ignore cosmetics-specific requirements: downstream traceability for recall, batch release, retention samples, allergen management, MoCRA Adverse Event reporting, fragrance allergen labeling, and the FDA / EU regulatory layer. The QSE Academy package is written specifically for ISO 22716 + FDA / MoCRA + EU 1223/2009 and includes the verifiable clause-by-clause mapping plus the 2025-2026 regulatory updates.
Plan 2 to 4 weeks to customize the documents: logo, organizational chart, real process map, specific equipment, regular suppliers, MoCRA Responsible Person, applicable jurisdictions (US only, US + EU export). Then plan operational implementation time: GMP training, IQ/OQ/PQ qualifications, cleaning validation, mock recall, internal audit — that's 8 to 16 additional weeks depending on facility size and starting maturity.
All policies, procedures, and templates are delivered in fully editable Microsoft Word (.docx) format. The mapping matrix (ISO 22716 ↔ FDA / MoCRA ↔ EU 1223/2009) is delivered in Excel. Master Batch Records (MBR), Batch Production Records (BPR), CoAs, and forms are delivered in editable Word/Excel formats. No locked PDFs, no proprietary software dependency. The graphic charter is neutral, ready to receive your logo and colors.
Yes. The package includes a dedicated FDA facility registration procedure covering MoCRA Section 607 requirements: who must register (any facility manufacturing or processing cosmetics for distribution in the US, with limited exemptions for small businesses under Section 612), what to register (facility name, owner, registration number, brands, product categories, etc.), when to register (within 60 days of starting operations or by July 1, 2024 for existing facilities), and biennial renewal requirements. The procedure also covers product listing obligations (Section 607).
Yes. The core 15 ISO 22716 chapters apply universally. The FDA / MoCRA layer (facility registration, product listing, AE reporting, fragrance allergen labeling, recall) covers US-only operations. The EU 1223/2009 layer (PIF, CPNP notification, EU Cosmetic Product Safety Report under Art. 10, EU Annex III allergens, cosmetovigilance under Art. 23) covers EU export operations. The mapping matrix shows how ISO 22716 satisfies both regulatory regimes simultaneously.
The $589 license covers a single legal entity, with unlimited internal use (all your employees can use the package). For multi-site rollout, a group with multiple subsidiaries, or consulting use across multiple clients, contact us for an adapted license.
Yes. The package already integrates the latest 2025-2026 regulatory landscape (ISO 22716:2007, FDA cosmetics regulations, MoCRA 2022, EU 1223/2009 with all current Annex amendments). In case of FDA final rules under MoCRA (GMP regulation, fragrance allergen list, etc.), EU Annex updates, or significant new guidance, you receive package updates free of charge for 12 months after your purchase.
You're covered by a 30-day money-back guarantee, no conditions. You write us a simple email — no justification required — and the refund is processed within 5 business days.
121 documents, 15 ISO 22716 chapters covered + FDA / MoCRA + EU 1223/2009 mapping, clause-by-clause matrix included. Instant download after payment.
QSE Academy supports quality managers, SMEs, and consultants in accelerating their ISO standards implementation through ready-to-use documentation, targeted training programs, custom documentation services, and compliance tools.
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