Undesirable effects and cosmetovigilance after product launch
How to receive, assess, document and report undesirable and serious undesirable effects associated with cosmetic products in the EU.
Read the guide →Service area 07 · specialist support
GMP, ISO 22716 and quality systems
Good Manufacturing Practice turns quality requirements into repeatable processes and credible records. We support manufacturers in building systems that match their real organisation and risks.
Scope of support
What we can deliver for your project
Gap assessments, documentation, SOPs, audits and practical support for cosmetic manufacturers implementing GMP and ISO 22716.
- 65Initial GMP gap assessment
- 66Preparation for ISO 22716
- 67Preparation of standard operating procedures
- 68Preparation of specifications for raw materials, packaging and finished products
- 69Preparation of batch manufacturing documentation
- 70Preparation of cleaning and hygiene procedures
- 71Supplier qualification
- 72Deviation and change control
- 73Implementation of a CAPA system
- 74Management of non-conforming products
- 75Implementation of complaint, withdrawal and recall procedures
- 76Internal GMP audit
- 77Audit of a contract manufacturer
- 78Staff training
- 79Preparation for an inspection or customer audit
Project outcomes
From a question to an actionable regulatory solution
The exact scope is confirmed after reviewing the product, target markets and available documentation.
01
GMP gap assessment and prioritised plan
02
SOPs and batch documentation
03
Deviation, CAPA and change-control system
04
Preparation for audits or inspections
Frequently asked questions
Before the project starts
Is ISO 22716 certification mandatory?+
Compliance with Good Manufacturing Practice is mandatory, whereas certification itself is not expressly required by the Cosmetics Regulation.
Can you prepare SOPs?+
Yes, with procedures tailored to actual processes, responsibilities and manufacturing scope.
Does EUCRI perform internal audits?+
Yes. An audit may cover the manufacturer’s system or selected contract partners.
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Read the guide →Next step
Do you have a product or portfolio for the EU market?
Send us the essential product details, target markets and available documentation. We will respond by email.