Cosmetic GMP and MoCRA Quality System
A complete, ready-to-implement quality management system for cosmetic manufacturers, fillers, packers and brand owners selling in the U.S. Built to ISO 22716:2007 Good Manufacturing Practices, ISO 9001:2026 and the FDA requirements of the Modernization of Cosmetics Regulation Act (MoCRA). 98 editable Word documents.
MoCRA made good manufacturing practice, adverse event reporting, facility registration, product listing and safety substantiation legal obligations for cosmetic companies. FDA can now inspect your records, suspend a facility registration and order a recall. This system gives you everything you need to meet those obligations and run a GMP operation an auditor or retailer will recognize.
What is included
Quality Management System Manual (QMSM-COS): your quality policy, organization, scope and processes, with a clause-by-clause cross-reference to ISO 22716 and to each MoCRA section.
53 standard operating procedures: document control, training, supplier qualification, receiving, calibration, cleaning and sanitation, purified water, microbiological control, batch records, line clearance, stability and shelf life, label review, QC laboratory, out-of-specification results, retained samples, complaints, serious adverse event reporting, recall, CAPA, internal audit, management review and more.
41 forms and records: adverse event intake and log, safety file checklist, margin of safety worksheet, registration and listing register, batch record review, water and environmental monitoring, microbial test records, OOS investigation, supplier GMP audit checklist, cosmetic label review checklist and others.
Organization chart and master document list: every document mapped to ISO 22716, ISO 9001 and MoCRA for straightforward audit planning.
Who it is for
Cosmetic, skin care, hair care and color cosmetic manufacturers
Brand owners using contract manufacturers
Contract manufacturers and fillers who need ISO 22716 for customers or retailers
Companies preparing for an FDA inspection or ISO 22716 certification
What you receive
Instant download of one organized zip file: a READ ME, the Quality Manual, lists, procedures sorted by section, and forms. All documents are editable Microsoft Word files (plus one Excel workbook).
Good to know
ISO 22716 is a copyrighted standard; the procedures refer to it by clause, and you will need your own copy. Already have a quality system? See the MoCRA Compliance Procedures for Cosmetics ($345) for the MoCRA obligations alone.
