GMP cosmetics: what your batch record must contain
Batch traceability is the cornerstone of cosmetic Good Manufacturing Practices (GMP). A well-prepared batch record is your best protection in case of an audit and guarantees consumer safety.
1What is a batch record?
The batch record (or manufacturing record) is the set of documents that traces the complete history of the manufacture of a cosmetic product. It must allow tracing of all production stages, from raw material procurement to placing the finished product on the market. Regulatory requirements under Regulation (EC) No 1223/2009 and ISO 22716 make these records mandatory for any product placed on the European market.
2Essential elements
A compliant batch record must contain: product identification (name, reference, batch number, manufacturing date and best-before date), a complete list of raw materials with their supplier batch numbers and certificates of analysis, manufacturing instructions followed step by step with actual weighed quantities, in-process controls with measured results (pH, viscosity, appearance), quality controls on the finished product, and time-stamped signatures of operators and the quality manager.
3The importance of time-stamping
Every action documented in the batch record must be precisely time-stamped. This allows reconstituting the exact chronology of manufacturing and detecting any anomalies in production timelines — a mixture left too long at high temperature, a shortened cooling step. In case of a complaint or product recall, time-stamping is the first thing authorities verify. With a digital system like Cosmetiqa, time-stamping is automatic and tamper-proof.
4Most common errors during GMP audits
Common errors during GMP audits include: uncountersigned corrections in paper records, missing signatures on certain steps, supplier batch numbers not recorded for raw materials, or theoretical quantities reported instead of actually weighed quantities. These discrepancies, even minor ones, can lead to non-conformities during an audit.
5How Cosmetiqa simplifies compliance
Cosmetiqa automatically generates the batch record from data entered during production. Every weighing, every control, every validation is recorded in real time with timestamp and operator ID. The final record is available as PDF, ready for a GMP audit, without any manual re-entry. In case of a product withdrawal or recall, complete traceability of the raw materials used is accessible within seconds.