GMP Manual for Cosmetics Manufacturers

Keeping your GMP manual for cosmetics updated is now a regulatory necessity under MoCRA. At Sobel, we review and revise your manual so it reflects real operations, aligns with FDA expectations, and becomes a practical tool for both daily use and audit readiness.

For who?

Let Sobel revise and update your GMP manuals so they accurately reflect current operations and align with FDA and MoCRA compliance standards.

Why do you need this service?

FDA now requires manufacturers to follow and document GMP principles; outdated manuals may result in non-conformities.

A complete GMP manual supports both FDA inspections and internal audits with clear, traceable documentation.

Updating your manual offers the opportunity to refine procedures, reinforce training, and strengthen CAPA systems.

From Review to Delivery: Updating Your GMP Manual

Through a structured review and update, Sobel delivers a GMP manual that reflects your operations, supports compliance, and prepares your facility for upcoming audits or inspections.

A structured process for GMP Manual compliance.

Document Collection

Gather old versions of your GMP manual and supporting records.

Structure & Compliance Review

Update regulations, review processes, training, and CAPA to ensure FDA/MoCRA alignment.

Final Delivery

Provide a complete, updated GMP manual ready for implementation.

Related
Services

We modernize and structure your GMP manual so it becomes a practical tool for daily operations and a strong asset during audits or inspections.

But you can complement your GMP manual update with:

Internal Audit

Prepare for FDA, GMP, or certification audits with expert support.

Elaboration of Standart Operational Procedure

Get FDA- and GMP-ready SOPs for your cosmetics business.

Supplier Audit

We audit cosmetic suppliers to ensure quality and GMP compliance.

Keep your GMP manual compliant and effective

An outdated GMP manual can put your company at risk.

With Sobel’s support, your GMP manual for cosmetics will be current, practical, and compliant with MoCRA, helping your facility face audits and inspections with confidence.

Still have questions? Checkout our FAQ

1. What is a GMP manual for cosmetics?

A GMP manual is the official document that describes your company’s Good Manufacturing Practices. It outlines how processes, quality controls, hygiene, storage, and staff training are managed. For cosmetic manufacturers in the U.S., this manual is a key tool to demonstrate compliance with FDA and MoCRA requirements.

2. Why does my company need to update the GMP manual?

MoCRA requires cosmetic manufacturers to follow and document GMP principles. An outdated manual may no longer reflect current operations or regulations, which can lead to findings during FDA inspections or internal audits. Updating your manual ensures both compliance and operational accuracy.

3. How often should the GMP manual be updated?

There is no fixed legal deadline, but updates should be made whenever regulations change (such as MoCRA) or when your company modifies processes, equipment, or quality systems. Sobel helps identify what needs to be revised and delivers a compliant, updated version.

4. Can we update the GMP manual internally?

Yes, your team can update the GMP manual internally. However, relying only on in-house resources may overlook regulatory details or structural gaps. By working with Sobel, you ensure the update is not just operationally accurate but also fully aligned with FDA and MoCRA requirements, giving your company more security and confidence during inspections or audits.