Beijing Explains Contract Manufacturing and Sample Retention for Cosmetics
What the Q&A covers
Beijing's cosmetics review and inspection center has issued the 62nd installment of its Q&A on ordinary cosmetics filing. It addresses the selection and oversight of contract manufacturers, controls when the commissioning party supplies materials, and the quantity and location of retained product samples. The Q&A explains existing provisions of the Cosmetics Good Manufacturing Practice rules and an earlier national regulator Q&A. It should not be read as a new product registration or filing procedure, or as a blanket increase in sample quantities.
Checking a manufacturer's license is only the first step
Before outsourcing production, a cosmetics registrant or filer should verify that the manufacturer holds the relevant production license and assess its quality management system and production capacity. The commissioning party should keep a list and management records for contracted manufacturers. It should also supervise their production activities. If a manufacturer's conditions or capacity no longer meet the outsourcing need, the commissioning party should stop the arrangement promptly and replace the manufacturer as needed. Where it supplies materials, it must maintain the applicable supplier selection, material review, receipt inspection, acceptance, and release controls.
How to use the sample quantity reference table
The underlying GMP requirement is to retain samples from every finished batch in an amount at least twice that needed for release testing and sufficient for product quality testing. The image table in the Q&A gives reference amounts for common products; it does not replace that underlying requirement with a universal minimum. For example, hair dyes call for at least three packages totaling at least 90 grams or milliliters; freckle removal or whitening products and sunscreens, at least three packages totaling 50 grams or milliliters; skin care products, at least three packages totaling 80 grams or milliliters; and products claiming an acne care effect, at least three packages totaling 200 grams or milliliters. For sheet masks in individually wrapped single pieces, the reference is at least seven sheets totaling 140 grams or milliliters. Boxed sheet masks call for at least three boxes containing at least seven sheets in total, with a combined amount of at least 140 grams or milliliters. Companies should still calculate quantities against their own products and testing needs; types absent from the table must be assessed under the applicable rules.
Retention location and reporting
For outsourced production, the Q&A explains that the commissioning party may retain samples at its domicile or main place of business, or at another business premises in the same locality. The locality is generally understood as the same prefecture-level city or the same municipality directly under the central government. If samples are kept somewhere other than the domicile or main place of business, the commissioning party must report the address and related information as required within 20 working days of first retaining samples there. A company should check its actual arrangements against these location and reporting points; keeping samples only at the contract manufacturer's site does not by itself establish that the commissioning party has met its own duties.
Practical checks for companies
Registrants and filers should consider reviewing their manufacturer qualification files, ongoing oversight records, and material control procedures. They can recalculate retention plans by product type, package size, and release testing need, and document any alternate retention address and the date samples were first kept there. These are practical checks against the published guidance, not a claim that the regulator has created new filing documents or a duty to refile.
