MoCRA Compliance Procedures for Cosmetics
Three procedures and eleven forms that cover the core MoCRA obligations for cosmetic companies: serious adverse event reporting, facility registration and product listing, and safety substantiation.
Under MoCRA, the responsible person for a cosmetic product must report serious adverse events to FDA within 15 business days, keep adverse event records, register facilities, list products and keep evidence that each product is safe. These procedures turn those requirements into clear steps with named owners and records.
What is included
SOP 8-101-COS Serious Adverse Event Handling and Reporting, with the intake and assessment form, adverse event log and channel register
SOP 7-102-COS Facility Registration and Product Listing, with the registration and listing register, small business assessment and submission checklists
SOP 7-101-COS Cosmetic Safety Substantiation, with the safety file checklist, ingredient safety review, exposure and margin of safety worksheet, safety assessment conclusion and annual review
Who it is for
Brand owners, distributors and manufacturers who already have a quality system, or who sell products made by a contract manufacturer.
What you receive
Instant download of one zip file with a READ ME, the 3 procedures and the 11 forms, all editable Microsoft Word files.
Need the full GMP system?
The Cosmetic GMP and MoCRA Quality System ($995) includes these procedures plus a complete ISO 22716 quality system of 98 documents.
