Templates and records · ISO 22716 · Clause 7.2
ISO 22716 cosmetic manufacturing batch record template
The full history of a bulk batch: which formula, which raw material batches, which equipment, which parameters and what the controls showed. It is what lets you reconstruct any incident.
In one sentence
The manufacturing batch record documents each batch of cosmetic bulk product — formula, equipment, batches and quantities of each raw material, operations with their temperatures, speeds and times, start-up checks and in-process controls — because ISO 22716 recommends manufacturing according to the manufacturing documentation, assigning a batch number and recording controls (7.2), and chapter 17 asks for documents that allow the history of each activity to be reconstructed.
- Where the standard requires it
- ISO 22716 · Clause 7.2 Chapters are those of ISO 22716:2007, the only edition published, confirmed by ISO in 2022. It is a guidelines standard: it recommends; the obligation comes from Article 8 of Regulation (EC) 1223/2009.
- Type of information
- Mandatory record ISO 22716 recommendation (7.2 and 17), enforceable through Article 8 of Regulation 1223/2009
- Who fills it in
- Manufacturing operator With verification of critical weighings and a final quality review before release
- When
- During manufacture Each entry is made at the time, not at the end of the shift
- How long it is kept
- Defined by the company ISO 22716 asks for the archiving period to be set according to applicable legislation (17.5.2). As a reference, the product information file is kept for ten years after the last batch was placed on the market (Article 11(1) of Regulation 1223/2009).
What the standard requires
What ISO 22716 demands and what it leaves to your judgement
The standard asks for manufacturing documentation to be available at each stage: suitable equipment, formula, list of raw materials with batch and quantity, and detailed operations — additions, temperatures, speeds, mixing times, sampling, cleaning and transfer. Before starting you must check that the documentation is available, the raw materials are released, the equipment is clean and the area has been cleared.
Each bulk batch is given a number that need not match that of the finished product, but must be easily linked to it. In-process controls have defined criteria, and any result outside them is reported and investigated.
The standard also asks for a maximum storage time to be defined for the bulk product, and for it to be re-evaluated if that time is exceeded (7.2.6).
Structure
Fields the template should include
- Product, code, formula version and bulk batch number
- Batch size and assigned equipment
- Start-up checks: documentation, raw material release, clean equipment, area clearance
- Each raw material with its batch, theoretical quantity and actual weight, and who weighs and verifies
- Operations with temperature, speed, time and clock time
- In-process controls with their criterion and result
- Incidents and deviations, with their reference
- Yield: quantity obtained against theoretical
- Container, location and use-by date for the bulk
- Quality review of the record
Example
Example: batch of moisturising cream
Company, people and figures are fictitious: the example only shows what a properly completed record looks like.
| Field | Content |
|---|---|
| Product and batch | Moisturising cream CH-30 · formula version 7 · bulk batch 26-0418 |
| Size and equipment | 400 kg · vessel R-02 |
| Start-up | Documentation, released raw materials, "clean" label and area clearance checked · 18 April, 07:30 |
| Oil phase | Cetearyl Alcohol batch 26-0117-04: 16.0 kg planned, 16.02 kg weighed, verified by a second person |
| Emulsion | Phases at 75 °C · homogeniser at 3,000 rpm for 10 min · 09:05 |
| Cooling | Preservative added below 40 °C, at 38 °C · 10:20 |
| In-process controls | pH 5.6 (specification 5.2 to 6.0) · viscosity 18,500 mPa·s (15,000 to 22,000) |
| Yield | 396 kg · 99% |
| Bulk | Container IBC-14 · bulk area · use before 18 May 2026 |
At the audit
Mistakes auditors commonly flag
- Weighings recorded without the batch of the raw material used.
- Records completed at the end of the shift, with times that do not add up.
- Corrections with crossings-out or correction fluid that make the original entry illegible.
- Out-of-criterion in-process controls that are noted but not investigated.
- Bulk stored beyond its maximum time without re-evaluation.
In Kimobox
How this record is kept in Kimobox
- 1Each manufacturing order is recorded with its parameters as a versioned record.
- 2In-process controls are linked to each batch.
- 3Quarantine and release of raw materials are managed in the same system, so the status of each batch used is visible.
- 4Full batch traceability, from raw materials to finished product, can be consulted from a single record.
Frequently asked questions
What people ask us before getting started
Must the bulk batch number and the finished product batch number match?
No. ISO 22716 allows different numbers provided they can be easily linked. Usually one bulk batch gives rise to one or more packaging batches.
How is a wrongly recorded entry corrected?
So that the original entry remains legible, with signature, date and, where appropriate, the reason. The standard asks for this explicitly for handwritten records (17.3.4); in an electronic system, the change history serves the same purpose.
Is this record part of the product information file?
Not directly. The product information file includes a description of the manufacturing method and a statement of compliance with good manufacturing practice (Article 11(2) of Regulation 1223/2009); batch records are the evidence behind that statement.
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Sources
Where each figure comes from
References to the official text in force. If a standard is revised, this page is updated and the review date says so.
- ISO 22716:2007 — Cosmetics. Good Manufacturing Practices (GMP). Guidelines on Good Manufacturing Practices ISO · 2007 ed., confirmed in 2022
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products EUR-Lex · 30 November 2009, consolidated text