Stage E · Specialist Tracks

Specialist track: Regulatory and Quality Specialization

Compliance and quality systems in depth, kept to current primary sources and dated.

0 of 8 lessons completed
By the end you will have: A quality and compliance file for one of your own fragrances, marked with what a qualified person must confirm.

Lessons

The compliance file

  1. Building a Fragrance Compliance File

    Structure a compliance file so every conclusion points to dated evidence, each document has an owner, and a formula change shows what must be rechecked.

    25 min · Exercise: Build the skeleton of a file

  2. Constituents of Naturals in Restriction Checks

    A restricted substance may arrive inside an oil as well as a pure line. Build a contribution table, handle ranges and unknowns, and find your limiting line.

    30 min · Exercise: A contribution table for one formula

  3. Allergen Calculation in Depth

    Calculate declarable allergens for the EU's 0.001% and 0.01% thresholds, including groups, naturals, compounds and data gaps, with worked problems.

    30 min · Exercise: An allergen worksheet for one product

Quality systems

  1. Specifications and Release Testing

    Turn a specification into a batch release decision: set ranges from data, measure refractive index, density and odor, then pass, hold or reject by rule.

    25 min · Exercise: A release decision on one batch

  2. Deviations and Corrective Action

    When a batch goes wrong, contain it, investigate the root cause, correct it and prevent it recurring. Practice with a worked deviation record for a small maker.

    25 min · Exercise: Write up one real or simulated deviation

  3. GMP Thinking for Small Makers

    What does good manufacturing practice mean at a small scale? Run a gap check based on ISO 22716's topics, fix the biggest risks and avoid false claims.

    25 min · Exercise: A GMP gap check

Across markets

  1. Building a Market Requirements Matrix

    Compare your target markets duty by duty in one dated table: who is responsible, what is notified, what the label needs, and what a new market would add.

    25 min · Exercise: A three-market matrix

  2. Specialist Project: A Compliance and Quality File

    Assemble a short quality manual and compliance file for one of your fragrances, run drills on it, and mark what a qualified person must still confirm.

    30 min · Exercise: Final project: a compliance and quality file