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CGA’s ISO 22716 GMP Program offers independent third-party audits, verified quality controls, and full regulatory readiness.
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ISO 22716 GMP Certification Process & Requirements
Dive into the core CGA ISO 22716 certification requirements in a clear, practical format.
Process
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GMP Gap Assessment The CGA technical experts begin with a structured evaluation of your current operation against ISO 22716 requirements.
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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.
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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.
Requirements
| 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 |
FAQ
Find quick answers to common questions.
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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Bundle ISO 22716 GMP Certification with other programs to optimize audits and reduce overall certification costs:
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Learn More About ISO 22716 GMP Certification
CGA’s ISO 22716 GMP Certification is trusted by retailers, exporters, and regulators internationally. Reach out to learn more, obtain a quote, or simply initiate the certification process today.