ISO 22716 Cosmetics GMP for Baby Care: Factory Audit Checklist for Buyers

When sourcing mom & baby care products, ISO 22716 Cosmetics GMP compliance is not just a factory credential—it’s a safeguard for product safety, traceability, and regulatory acceptance. Buyers who audit for GMP readiness can prevent delays, avoid compliance gaps, and ensure that every shipment is backed by verifiable evidence. This guide focuses on practical, audit-ready steps for factory evaluation.

Why ISO 22716 Matters in Baby Care

• Products for infants and toddlers are subject to higher scrutiny for microbiological purity and allergen control.
• ISO 22716 provides documented Good Manufacturing Practices aligned with EU, US, and many Asia-Pacific regulatory expectations.
• Auditing against ISO 22716 helps confirm that your supplier can handle sensitive formulas without cross-contamination.

Factory Audit Checklist: Core Areas

1. Documentation & Records

• Quality Manual: Ensure ISO 22716 procedures are documented and up to date.
• Batch Records: Review recent production records for baby care SKUs.
• Ingredient Traceability: Confirm supplier lists and certificates.
• Microbiological Test Reports: Verify testing is done per batch, with infant-safe thresholds.

2. Facility & Equipment

• Cleanroom or controlled environment for filling baby products.
• Dedicated tooling for allergen-free and fragrance-free products.
• Preventive maintenance records to reduce mechanical contamination risk.

3. Personnel & Training

• Operator training logs focused on hygiene and cross-contamination prevention.
• Appropriate attire protocols, especially in batching/filling zones.
• Health screening policies for production staff.

4. Packaging Controls

• Incoming packaging QC (material safety, migration tests).
• Compatibility checks with formulations (no plasticizer leaching, seal integrity).
• Lot coding and tamper-evident sealing procedures.

Mini Table: Evidence to Request

Audit Walkthrough Recommendations

1. Start at raw material receiving—verify inspection protocols.
2. Observe batching to confirm ingredient weighing controls.
3. Check filling/packaging lines for cleanliness and segregation.
4. Review final product release procedures and QC sign-off.
5. Investigate any non-conformance records and corrective action timelines.

FAQ

What is ISO 22716?

ISO 22716 is an international standard outlining Good Manufacturing Practices for cosmetics, focusing on documentation, quality controls, and hygiene.

Can a factory produce baby care without ISO 22716?

Technically yes, but many markets require GMP-compliant documentation. Without ISO 22716, you may face regulatory rejections.

How often should I audit a supplier?

For baby care, annually is recommended, with spot audits if there are formula changes, new packaging, or quality incidents.

What are microbiological limits for baby products?

Limits vary by market; many target <100 CFU/g total count and absence of pathogens per batch.

Request a Quote to audit or source baby care products under ISO 22716 GMP. Provide your target market, SKU details, positioning, packaging direction, and timeline to speed up response.

Hi, I'm Alex Zong, hope you like this blog post.

With more than 20 years of experience in OEM/ODM/Private Label Cosmetics, I'd love to share valuable knowledge related to cosmetics & skincare products from a top-tier Chinese supplier's perspective.