A worked cosmetic PIF example with review notes

An example that shows the unresolved work

This example uses a wholly synthetic product and document list. It demonstrates how to organise a PIF review. It is not a compliant specimen, an assessor-signed report or a set of documents that can be copied onto a real product.

The example follows the distinction between the wider PIF and its supporting components described in HPRA guidance. Every substantive conclusion remains open until a competent reviewer has assessed the actual evidence.

Identify the fictional product

Sample Product A is a proposed face oil in a 30 ml bottle. The workspace records Ireland/EU as the intended market. Its internal record is version 2. No formulation percentages or finished-product safety conclusions are supplied in this example.

The product description names version 2, but the supplier bundle has no clear relationship to that version. An artwork file is labelled draft. These are facts about the record, not proof that the product or evidence is adequate.

Record each evidence state separately

• Product description: file present; product/version link recorded; substantive review pending.
• Safety report: no current assessor-signed report recorded; information requirements to be agreed with the assessor.
• Manufacturing information: working note present; completeness and GMP context not yet checked.
• Claims support: artwork refers to a claim, but its supporting evidence is not linked.
• Other applicable information: scope and evidence questions remain for the specialist.

The point is not to fill every row with a positive state. A useful example shows where the team must ask a question and what would be needed to answer it.

Turn the gaps into actions

Assign one person to confirm the current specification and supporting supplier information. Create a separate action to agree the safety-assessment handover. Link the claim question to the exact artwork version. Ask the specialist to identify the remaining evidence and applicability checks.

Do not close an action merely because a new attachment arrives. Record what was received and retain the question for the person who needs to assess it. A document can be present while its completeness or relevance is still unresolved.

Preserve the outcome against the revision

When the specialist records findings, include the product revision, reviewed material, date and limitations. If the product description or evidence changes, retain the earlier findings as history and make the current review state explicit.

The accompanying synthetic index is intended for review alongside this narrative. Use the index with its source mapping and the review information shown on the page. The example must remain labelled synthetic wherever it is shown or downloaded.

Sources and legal dates