We help cosmetic makers, contract manufacturers and private label houses put ISO 22716 GMP in place and pass their certification audit. One team handles the gap assessment, documents, training and mock audit, on a fixed fee.
What Our Cosmetics GMP Consulting Scope Covers
| Cosmetic GMP gap assessment | We write or rework the procedures, forms and records the standard expects, using your equipment names and your real process. If you already have an ISO 9001 or food GMP system, we build on it. |
| SOPs, batch records and quality documents | We write or rework the procedures, forms and records the standard expects, using your equipment names and your real process. If you already have an ISO 9001 or food GMP system, we build on it. |
| Training for your team | On-site GMP training for operators, supervisors and QA staff, with attendance records and a short competence check your auditor can review. |
| Internal audit and mock certification audit | Before the real audit we run a full cosmetic GMP audit the way a certification body would, then help you close every finding. |
| MoCRA compliance support | Facility registration and product listing through FDA’s Cosmetics Direct portal, adverse event record-keeping, and safety substantiation files. We fold this into the same project so your MoCRA records and GMP records match. |
| Support on audit day | We can be on site or on call during the certification audit and help you write corrective actions afterwards. |
Who we work with
- Contract manufacturers
- Private label houses
- Brand owners
- Direct Manufacturers
GMP Consultancy Process
Our GMP consulting roadmap ensures every critical aspect of your manufacturing operation is reviewed, documented, and aligned with internationally recognized quality standards.
Step 1: Initial Consultation & Facility Understanding
The process begins with a technical consultation to understand your facility, production processes, and regulatory objectives.
During this stage we review:
- Product categories and manufacturing scope
- Current quality management systems
- Target certifications or regulatory requirements
- Existing SOPs and documentation
- Export markets and compliance expectations
Step 2: GMP Gap Assessment
CGA consultants conduct a comprehensive GMP gap analysis to evaluate how your current operations compare with recognized GMP standards.
This assessment typically includes:
- Facility layout and hygiene controls
- Raw material management and supplier qualification
- Production process controls
- Equipment cleaning and maintenance procedures
- Personnel hygiene and training programs
- Documentation and recordkeeping practices
- Traceability and recall procedures
A structured Gap Assessment Report is provided outlining compliance gaps and recommended corrective actions.
Step 3: Quality System Development
Once gaps are identified, our consultants work with your internal team to design and implement the documentation and procedures required for GMP compliance.
This phase may include development of:
- Quality manuals and policies
- Standard Operating Procedures (SOPs)
- Batch production records
- Cleaning and sanitation procedures
- Supplier approval programs
- Deviation and corrective action systems
- Document control and record management systems
Step 4: Facility Controls & Operational Implementation
GMP requirements must be fully integrated into production activities. CGA assists facilities with implementing operational controls such as:
- Production line segregation where required
- Hygienic zoning and contamination prevention
- Environmental monitoring procedures
- Equipment validation and maintenance schedules
- Storage and inventory control systems
Step 5: Employee Training & GMP Awareness
Employee training is essential for maintaining GMP compliance.
CGA provides structured training sessions covering:
- GMP fundamentals for production teams
- Hygiene and contamination prevention
- Documentation and recordkeeping procedures
- Responsibilities of supervisors and quality managers
- Internal audit preparation
Step 6: Internal Audit & Mock Inspection
Before a formal certification or regulatory audit, CGA conducts a mock inspection to evaluate readiness. This includes:
- Review of GMP documentation
- Facility walkthrough inspection
- Verification of records and logs
- Evaluation of employee understanding
- Identification of remaining non-conformities
Corrective actions are then implemented to ensure full audit readiness.
Step 7: Certification or Regulatory Audit Preparation
Once the facility demonstrates GMP compliance, CGA assists with final preparation for third-party audits or inspections.
This may include:
- Certification body audit preparation
- Regulatory inspection readiness
- Documentation review and final corrections
- Support during audit coordination
Facilities completing the roadmap are typically well positioned for successful certification outcomes.
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 |
Talk to a cosmetic GMP consultant this week
Tell us about your products and your deadline. We will tell you where you stand and what it will take.
Frequently Asked Questions (FAQs)
ISO 22716 is the international guideline for good manufacturing practice in cosmetics. It covers production, control, storage and shipment of cosmetic products, and it is the GMP reference used under EU cosmetics law.
No. ISO 22716 certification is voluntary in the US. MoCRA directs FDA to set cosmetic GMP regulations, and many retailers and brand owners already ask suppliers for ISO 22716 certification.
Usually three to six months from gap assessment to certification audit, depending on where you start.
ISO 9001 is a general quality management standard for any industry. ISO 22716 is specific to cosmetic manufacturing and goes into detail on hygiene, materials, production and product release. Many sites hold both.
Most facilities that manufacture or process cosmetics for sale in the US must register with FDA and list their products. Some small businesses are exempt, with exceptions for certain product types. We can check your status on the scoping call.
Documents, training and reviews can be remote. We recommend at least one on-site visit for the gap assessment and the mock audit.
Can’t find what you’re looking for?
Start Your GMP Compliance Program
If your facility is preparing for GMP certification, regulatory inspections, or quality system improvements, CGA Technical Services can help.
Our consultants will evaluate your current systems and develop a structured plan to achieve GMP compliance efficiently.
Get in touch with our GMP consultants at +1 813 906 8113 or simply complete the form below.