In short
Good manufacturing practice means organizing your work so each batch is made the same way, from known materials, in clean conditions, by people who know what to do, with records to show it. For a small maker, this can be modest, though it can't be absent if you sell in a market that requires it. In the EU, Article 8 of Regulation 1223/2009 requires GMP, and following the relevant harmonized standard, ISO 22716, gives a presumption of compliance. The GMP guide gives an overview. Here you will apply it to your own room.
What you will learn
- Explain the logic behind GMP
- Run a gap check against ISO 22716's topics
- Choose proportionate improvements, and describe them accurately
Before this lesson: Deviations and Corrective Action
The logic
GMP asks you to prevent four main problems: mix-ups, contamination, errors and undocumented change. Each section of a standard largely addresses one of those. If you understand these, its rules start to make sense.
A gap check
| Topic | A small maker's question | Evidence you might have |
|---|---|---|
| Personnel | Who does what, and are they trained for it? | Training notes |
| Premises | Is the space separate from home life, clean and ordered? | Floor plan, cleaning log |
| Equipment | Are scales checked? Vessels clean? | Calibration log |
| Raw materials and packaging | Goods-in checked, labeled, stored, rotated? | Goods-in forms |
| Production | Is there a master record, with lots noted at weighing? | Batch records |
| Finished products | Is there a release decision, and is stock controlled? | Release records |
| Quality control | Which tests, on what basis? | Specification |
| Out-of-specification | What happens with a failure? | Deviation records |
| Waste | How is chemical waste handled? | Procedure, local rules |
| Subcontracting | Are others' responsibilities written down? | Agreements |
| Deviations | Recorded and reviewed? | Log |
| Complaints and recalls | Can you act quickly? | Log, drill |
| Change control | Are changes reviewed before use? | Change log |
| Internal audit | Do you check that you follow your rules? | Annual review |
| Documentation | Is everything current, findable and kept? | Index |
Prioritizing
Score each gap for how likely it is, and how bad it would be. Fix the worst first.
| Gap | Likelihood | Severity | Score | Action |
|---|---|---|---|---|
| Lookalike bottles, no code check | 4 | 5 | 20 | Add a check to the record; relabel |
| Scale never checked | 3 | 4 | 12 | Monthly test with a known weight |
| Cleaning not logged | 3 | 2 | 6 | Simple log |
Small-scale realities
- Home workspaces. Some jurisdictions have specific rules on domestic production, and insurers may too. Check them. Keep materials away from food, children and pets.
- Working alone. You can't double-check yourself in the moment. Use barcode-like checks, weigh-and-tick records and a delay before sign-off.
- Procedures. Short ones, as described in lab SOPs, are better than long ones you won't read.
- Contract manufacture. A manufacturer's GMP doesn't remove yours as a brand. Agree who does what.
- US and other markets. MoCRA requires FDA to establish GMP regulations, with exemptions for some small businesses. Check their status.
Describing it honestly
| Avoid unless true | Say instead |
|---|---|
| ISO 22716 certified | We use ISO 22716 as a guide; we haven't been audited |
| GMP approved | Our procedures are described in our quality file |
| Made in a sterile lab | Made in a dedicated, cleaned workspace |
Practical exercise: A GMP gap check
- Walk through your workspace with the gap table, recording evidence for each row.
- Score each gap, and pick your top three.
- Write two one-page procedures: one for weighing a batch, and one for goods-in or cleaning.
- Test a procedure by having someone follow it.
- Set a date to review the table in three months.
- Find out what your market requires, and note the source and date. Mark what you'd ask a qualified person.
You have done this well if your gaps are specific, your first fixes target your largest risks, and nothing you say about yourself overstates what's been done.
Common mistakes
- Writing procedures you don't follow. That's worse than none.
- Treating GMP as paperwork. The records serve the batch.
- Claiming certification. Only if you hold it.
Key terms
- Good manufacturing practice
- An organized way of making products so that they are consistently produced and controlled to appropriate standards.
Knowledge check
Written and reviewed by the RUŌOD Lab team. This is general education, not legal, regulatory, medical or safety advice. Example dilutions and exercises are for learning, are not validated products, and have not been safety-assessed. Completing a lesson confers no qualification. How we check these lessons.