ISO 22716 Cosmetics GMP Audit Checklist

A working checklist for good manufacturing practice (GMP) audits in a cosmetics plant, organised by the topics of ISO 22716:2007 — the ISO guideline on the production, control, storage and shipment of cosmetic products. Use it for internal audits, for preparing for a customer or certification audit, or for auditing a contract manufacturer or filler.

What is inside

ISO 22716 Cosmetics GMP Audit Checklist — 119 checks in 12 sections: personnel; premises; equipment; raw materials and packaging materials; manufacturing; packaging; finished products; the quality control laboratory; out-of-specification product and wastes; subcontracting and deviations; complaints, recalls and change control; internal audit and documentation. Each check is a statement you can find evidence for, with Yes / No / N/A boxes, space for notes and a score table.

The document as a designed, print-ready PDF and as an editable Word file.

Who it is for

Quality assurance and quality control managers, production and warehouse managers, internal auditors and consultants in cosmetics and personal care manufacturing — and brand owners who need to audit the companies that make or fill their products.

How to use it

Walk the plant in the direction the product travels: goods-in, raw material and packaging stores, weighing, manufacturing, bulk storage, filling and packaging, finished goods and dispatch, then the laboratory and the records. Pick one recent batch and trace it both ways — back to the raw material lots and their release, and forward to the finished product release. Look for evidence for each check rather than asking whether a procedure exists. For every No, write a finding that states what good practice expects, what you saw and where, then agree a cause, an owner and a date.

ISO 22716 is a guideline about product quality. It does not cover the safety of people working in the plant or the protection of the environment, and it does not replace the cosmetics regulations of the markets you sell into, which may set requirements for GMP, product safety, labelling and notification. Check the legal requirements that apply to you, and check which edition of the standard applies.