CGA helps manufacturers implement ISO 22716 efficiently through a structured framework that ensures control over production, storage, and quality in line with Cosmetics GMP practices.
What is ISO 22716?
ISO 22716 is the international standard for Good Manufacturing Practices (GMP) in the cosmetics industry. It provides a structured framework for controlling production, quality, hygiene, and documentation. The standard ensures products are consistently manufactured and meet safety and regulatory expectations. It is widely used to support compliance with global regulations, including those in the EU and other key markets.
ISO 22716 GMP Certification Requirements
Below are the general ISO 22716 GMP certification requirements and serves as a practical checklist to understand what the standard requires:
Section | What Is Required | Assessment Requirements | |
1. Organization & Personnel | Defined roles for GMP oversight and quality responsibilities | Org chart, job descriptions, GMP accountability | |
| Documented GMP training program for all staff | Training records, onboarding + periodic refreshers | ||
| Personal hygiene procedures and controls | PPE use, hand hygiene, behavior on floor | ||
| 2. Facility Requirements | Logical flow to prevent contamination | Zoning (raw vs finished), process flow | |
| Cleaning schedules and facility upkeep | Cleaning logs, maintenance records | ||
| Controlled water, air, and waste systems | Water testing, HVAC controls | ||
| 3. Equipment | Equipment suitable for intended use | Equipment list, qualification records | |
| Cleaning procedures and preventive maintenance | Cleaning logs, calibration records | ||
| Measurement equipment accuracy | Calibration certificates and schedules | ||
| 4. Raw Materials & Packaging | Approved supplier system | Supplier qualification records | |
| Verification of raw materials | COAs, inspection records | ||
| Controlled storage conditions | Labeling, segregation, FIFO/FEFO | ||
| 5. Production | Defined manufacturing instructions | Batch records, consistency checks | |
| Measures to prevent contamination | Line clearance, cleaning validation | ||
| Monitoring during production | QC checkpoints, test records | ||
| 6. Finished Products | Formal release by authorized personnel | QA approval records | |
| Defined product standards | Product specs, testing results | ||
| 7. Quality Control Laboratory | Raw material and finished product testing | Lab results, test methods | |
| Shelf-life validation | Stability studies, reports | ||
| 8. Documentation & Records | Written procedures for all critical operations | SOP library, version control | |
| Complete and traceable records | Batch records, logs | ||
| Accuracy and reliability of records | Controlled edits, audit trails | ||
| 9. Storage & Distribution | Controlled storage environment | Temperature logs, segregation | |
| Product traceability post-production | Shipment records, tracking | ||
| 10. Complaints & Recalls | System to capture and investigate complaints | Complaint logs, CAPA actions | |
| Ability to recall products effectively | Mock recall tests, procedures | ||
| 11. Subcontracting | Oversight of outsourced processes | Agreements, audits of contractors | |
| 12. Deviations & CAPA | Identification and documentation of issues alongside the presence of root cause analysis and corrective actions within SOPs | Deviation reports, CAPA records | |
| 13. Internal Audits | An SOP present for regular GMP internal audits | Audit reports, follow-ups | |
| 14. Change Control | Controlled process for changes | Change logs, approvals | |
| 15. Risk Management | Identification of GMP risks | Risk assessments, mitigation plans |
CGA Assessment Process
Below is the simple 3-step CGA ISO 22716 GMP Assessment process:
Step 1: GMP Gap Assessment
The CGA technical experts begin with a structured evaluation of your current operation against ISO 22716 requirements.
What is evaluated:
- Review your facility layout, material flow, and hygiene zoning
- Assess existing SOPs, batch records, and documentation structure
- Evaluate supplier approval processes and raw material controls
- Identify cross-contamination risks, especially on shared equipment or lines
- Review storage, labeling, and traceability practices
- Review storage, labeling, and traceability practices
Once the evaluation is completed, CGA’s technical team submits a complete package that includes:
- A clear gap assessment report focused on what actually matters for certification
- A prioritized action plan based on audit risk, not theory
- Early identification of critical issues that could delay certification
Step 2: ISO 22716 System Development & Implementation
This is the most critical step towards building an ISO 22716 GMP system. Based on the previous assessment, the CGA team assists facilities in building a comprehensive GMP structure:
The program development involves:
- Develop and refine SOPs aligned with ISO 22716 requirements
- Establish batch documentation, traceability flow, and record-keeping systems
- Define cleaning procedures, line clearance, and contamination control measures
- Set up supplier approval, material verification, and incoming inspection controls
- Align roles, responsibilities, and training expectations across teams
Step 3: Pre-Audit Readiness Review
Once the GMP program is established, the CGA team supports the facility in preparing for the official audit. Prior to the certification audit, our technical team assesses your system under real audit conditions.
What CGA performs:
- Conduct a mock audit based on ISO 22716 requirements
- Review documentation, records, and traceability from raw material to finished product
- Walk through production areas to identify gaps in practice vs procedure
- Highlight areas that are likely to be flagged by auditors
- Verify that corrective actions have been properly implemented
Speak to an Expert
ISO 22716 is straightforward when it’s structured properly. If you’re considering GMP certification, the fastest way forward is a focused discussion on your current setup, products, and target markets.
The CGA technical team will walk you through:
- Where you stand against ISO 22716
- What gaps actually matter for certification
- Expected timelines and scope
- How to structure your GMP system efficiently
Reach out to an expert by calling +1 (813) 906 8113 or by completing our form.
Frequently Asked Questions (FAQs)
ISO 22716 itself is not always legally mandatory, but it is widely expected by regulators, retailers, and distributors. In markets like the EU and GCC, GMP compliance aligned with ISO 22716 is often treated as a baseline requirement for market access.
Timelines depend on your current level of readiness. Most facilities complete the assessment process within 2 to 8 weeks, while more complex operations may take longer. The biggest factor is how quickly gaps are addressed and systems are implemented.
No. Most companies begin with partial systems or gaps. CGA starts with a structured assessment and builds the GMP framework alongside your team, ensuring it aligns with your actual operations.
- The most common issues include:Weak or incomplete documentation
Poor traceability and batch records
Lack of control over raw materials and suppliers
Inconsistent implementation of SOPs on the production floor
These are areas CGA focuses on early to reduce audit risk.
ISO 22716 is a cosmetics-specific GMP standard, focused on production, hygiene, and product safety. ISO 9001 is a broader quality management system applicable across industries. Many manufacturers use both, but ISO 22716 is more directly relevant for cosmetic production.
You will need structured documentation including:
-
Standard Operating Procedures (SOPs)
Batch manufacturing records
Cleaning and maintenance logs
Supplier approval and raw material verification records
Training records
All documentation must be controlled, traceable, and consistently followed in practice.
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