Carat Global Assurance (CGA) has one of the only dedicated GMP certification programs dedicated specifically to e-commerce businesses. The CGA GMP Program for e-commerce businesses is actively catering to the following product scopes:
CGA’s GMP audits are designed for manufacturers of dietary supplements, food products, cosmetics, pharmaceuticals, and specialty chemicals.
In this Page:
GMP Audit Requirements
Here are the general GMP audit requirements in accordance with the CGA standards:
| GMP System Area | What CGA Auditors Verify | What Must Exist in Your Facility |
| 1. Facility & Infrastructure | Building design, hygienic zoning, airflow, drainage, pest-proofing, contamination risk | Hygienic layout, physical segregation of raw & finished goods, controlled access, validated sanitation zones |
| 2. Utilities & Environment | Water quality, compressed air, HVAC, lighting, waste control | Potable water testing, filtered air systems, waste management SOPs, environmental monitoring |
| 3. Equipment & Utensils | Cleanability, material suitability, maintenance, calibration | Stainless steel or food-grade materials, maintenance logs, calibration records |
| 4. Cleaning & Sanitation | Cleaning methods, chemical control, validation | Written cleaning SOPs, approved detergents, sanitation schedules, verification records |
| 5. Pest Control | Risk control without contaminating products | Contracted pest control, trap maps, inspection logs |
| 6. Raw Material Control | Supplier approval, COAs, risk classification | Approved supplier list, COAs, ingredient traceability, quarantine area |
| 7. Receiving & Storage | Segregation, FIFO, temperature, labeling | Clearly labeled materials, controlled storage, expiry management |
| 8. Production Control | Process consistency, error prevention | Master manufacturing records, batch production records, deviation handling |
| 9. Cross-Contamination Control | Allergen, chemical, microbial risk | Physical segregation, cleaning validation, dedicated tools or validated changeover |
| 10. Packaging & Labeling | Correctness, traceability, regulatory compliance | Label approval system, packaging logs, reconciliation process |
| 11. Traceability & Recall | Ability to trace forward & backward | Lot coding, mock recall tests, distribution records |
| 12. Quality Management System (QMS) | Control of documents, changes, errors | SOPs, document control, CAPA system, internal audits |
| 13. Nonconformance & CAPA | How failures are detected & corrected | Root cause analysis, corrective actions, effectiveness checks |
| 14. Complaints & Adverse Events | How product issues are handled | Complaint logs, investigation reports, regulatory escalation |
| 15. Personnel & Training | GMP knowledge and hygiene discipline | Training records, hygiene SOPs, job qualification |
| 16. Warehousing & Distribution | Product protection after manufacturing | Temperature control, loading hygiene, shipping logs (where applicable) |
| 17. Regulatory Compliance | FDA, ISO, international GMP alignment | CFR-aligned SOPs, inspection readiness, audit history |
| 18. Product Safety & Risk | HACCP, contamination control | Hazard analysis, CCPs, preventive controls |
Benefits of GMP Audit Services
The CGA GMP audit service is designed to meet the compliance, quality, and market-access requirements of manufacturers across different sectors. Here are some of the key benefits:
1. Gain Compliance to FDA, Retailer & Import Inspections
CGA GMP audits are in alignment with FDA CFR, ISO, and global regulatory frameworks. Therefore, the CGA GMP audit will help your facility get inspection-ready for:
- Private label buyers
- FDA
- Amazon & Walmart
- International customs
2. Reduce Product Recalls & Liability
Most recalls happen because of:
- Weak supplier control
- Poor sanitation
- Missing traceability
CGA GMP audit systems close those gaps before they become a risk for companies.
3. Win Bigger Customers
Large retailers, distributors, and multinational brands do not onboard manufacturers without a third-party GMP audit. CGA’s GMP audit service will offer confidence that the facility processes are controlled and audited, subsequently helping manufacturers tap into higher-value contracts.
Bundle & Save with Multi-Certification Audits
CGA offers combined audit programs so you can certify faster, more cost-effectively:
- Good Manufacturing Practice (GMP) Certification
-
Halal Certification For access to Muslim-majority markets and ethical labeling
-
Non-GMO Verification Align with clean-label and natural product trends
-
Gluten-Free Certification Serve consumers with dietary restrictions with confidence.
-
Vegan Certification Appeal to plant-based product buyers with third-party validation.
Speak to a GMP Audit Expert
Get in touch with our GMP audit specialists by calling in at +1 813 906 8113 or simply completing the form here.
FAQ
Find quick answers to common questions.
CGA GMP audits align with FDA regulations (21 CFR Part 111 and 117), ISO 22000, ISO 22716, WHO GMP, and global retailer and import requirements. This allows manufacturers to use one audit to support multiple regulatory and commercial pathways.
The timeline depends on facility size and readiness. Most GMP audits can be completed within a few weeks, including document review, on-site or remote audit, corrective actions, and certificate issuance.
If gaps are identified, CGA provides a structured corrective action process. Once issues are corrected and verified, certification can be issued. This ensures long-term compliance, not just a one-time pass.
CGA audits facilities, equipment, cleaning systems, raw material control, batch records, supplier qualification, employee training, traceability, deviation management, and quality systems. This ensures GMP is implemented in real operations, not just on paper.
Costs depend on:
- facility size and complexity
- number of sites
- number of product categories
- readiness level
To get an accurate quote, complete the form here.
Yes. CGA offers integrated audits combining:
-
- GMP
- Halal
- Vegan
- Non-GMO
- Gluten-Free
- ISO-based systems
This reduces audit time, disruption, and overall cost.
Can’t find what you’re looking for?