PIP

PRODUCT INFORMATION PACKAGE

Primary Information

Product ID and codes

Product formula

Product formula cross-referencing INCI names

Raw ingredient specifications and references to test methods

Manufacturing procedure summary or single page flow chart

Summary GMP statement

Product safety assessment statement signed

Undesirable health effects summary

Claim substantiation summary with references

Documents are cross-referenced from Finished product code and Formulation code number and Product name as appropriate. (All information could be available within a few hours).

Additional Information

2-page safety assessment covering all raw ingredients (Dweck Data data base)

Stability summary, with reference to methods

Manufacturing procedure

Undesirable health effects; summary of adverse effects

Summary of claim support evidence, with references to other reports or documents.

Support Data

Full toxicology background data on individual ingredients

Copies of toxicology and safety test reports

Copies of efficacy claim test reports

Microbiology test methods

Stability test methods

Raw ingredient specification test methods

Finished product specification test methods

Stability data

Microbiological safety challenge test records

Batch control records (held in production)

GMP procedures

Standard Operating Procedures

GMP records (held in production)