— 5 steps to compliance & safety —
PIF building
A well-structured product information file (PIF) is indispensable, central to many regulatory processes, and a legal requirement. The product dossier includes key information on raw materials, suppliers, production methods, products, producers, brand owners, and the consumer history of use of the products.
What does a Product Information File contain?
Depending on the product, it may include:
- Product description and formulation
- Cosmetic Product Safety Report (CPSR)
- Manufacturing information and GMP statement
- Raw material and packaging documentation
- Product labels and artwork
- Claim substantiation
- Stability and compatibility data
- Microbiological and challenge test reports
- Consumer undesirable effects and cosmetovigilance records
The basis for compliance and safety
At the start, we will work with you to build a comprehensive and compliant product information file (PIF). We will provide clear instructions and checklists for your R&D, manufacturing, QC and procurement departments to ensure that all required data, documents and test reports are timely and correctly included in the PIF.
The PIF contains basis input for many mandatory activities such as the safety assessment, label and label ingredients review, and the mandatory cosmetic product safety report (CPSR). And the PIF needs continuous updating when for example raw materials, suppliers and/or labels change.
Cosmetovigilance records need to be continuously updated to include the latest information on the consumer history of use and potential (serious) undesirable effects.
The Product Information File must be readily available to the competent authorities upon request throughout the product lifecycle and maintained for ten years after the last batch has been placed on the market.
Fully digital
We manage product PIFs and compliance in PRIMS, our proprietary cloud software solution for cosmetics. Working in PRIMS delivers great efficiency and data quality and collaboration across the entire compliance process.
PRIMS has been developed in house specifically to manage cosmetic product regulatory compliance, to build and maintain full up-to-date PIFs, and provide real-time insights in full portfolio safety and compliance against the latest included regulatory and toxicology data.
The use of the PRIMS cloud software solution has proven key in passing authority inspections with our clients by providing complete, consistent and readily accessible product documentation.
Whether you are launching your first cosmetic product or managing an international portfolio, TRC helps you build and maintain complete, inspection-ready PIF throughout the product lifecycle.
