What Is GMP?

Good Manufacturing Practice (GMP) is a set of guidelines for ensuring that products are consistently produced and controlled according to quality standards. For cosmetics and personal care products in the US, the FDA outlines GMP in 21 CFR Part 211. While full GMP compliance is complex, the core principles are straightforward and benefit any maker — even a one-person workshop.

Core GMP Principles for Crafters

1. Traceability — You must be able to trace any finished product back to the exact lots of ingredients used.
2. Batch records — Every batch must have a record of what was made, when, by whom, and with what ingredients.
3. Lot tracking — Ingredient lot numbers must be recorded per batch so that if a problem arises, you can identify which batches are affected.
4. Expiration dating — Products and ingredients should have expiration or best-by dates.
5. Quality control — Inspect finished products for quality before they go to the shelf.

How Apothecary Wizard Supports GMP

Apothecary Wizard was designed with GMP in mind. Here is how the system supports each principle:

• Traceability: The batch lot allocation system records exactly which lot of each ingredient went into each batch. When you create a batch, you select specific lots from your inventory and record the weight used from each.
• Batch records: Every batch entry captures the recipe, manufacture date, cure end date, yield, and notes. This is your batch record.
• Lot tracking: Ingredient lots carry supplier name, lot number, and expiry date. When allocated to a batch, the link is permanent in the database.
• Expiration dating: Ingredient lots have expiry dates. Finished products can be assigned shelf life based on recipe and ingredient stability.

Batch Labels

Apothecary Wizard generates printable batch labels that include the batch ID, manufacture date, cure date, recipe name, and ingredient list (INCI names). Affix these labels to your curing racks and finished product boxes for complete traceability.

The FDA Landscape

The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 expanded FDA oversight of cosmetics. Key requirements include facility registration, product listing, adverse event reporting, and safety substantiation. If you sell cosmetics across state lines, you may be subject to these requirements. Consult the FDA website or a regulatory consultant for current requirements applicable to your business size.

Disclaimer

This article is for informational purposes only and does not constitute legal or regulatory advice. Apothecary Wizard provides tools to support good manufacturing practices, but compliance with applicable regulations is your responsibility.