ISO 22716
Good manufacturing practices applied to cosmetic processes and associated operations within the relevant scope.
Integrated quality
Quality is not declared. It is designed, recorded and demonstrated.
We integrate risk, control and documentation from product definition onwards, giving every process clear criteria, traceable data and a consistent review pathway.
01—04
The framework follows the product
ISO 9001
Process management, document control, indicators and continuous improvement as an organisational foundation.
ISO 13485
Reference framework for medical-device projects when classification and scope require it.
Batch control
Raw materials, critical parameters, in-process controls, packaging and final documentation review.
Evidence that follows the process
- Raw-material and batch traceability
- Master and batch manufacturing records
- In-process controls
- Supplier qualification and monitoring
- Change control
- Deviation and corrective-action management
- Cleaning, maintenance and equipment status
- Batch documentation review
References to standards must not be interpreted as certifications outside the current documented scope.
Verifiable decisions
How risk becomes control
Quality begins before the batch, with critical attributes, materials, methods, acceptance limits and responsibilities.
Product risk
Composition, intended use, stability, microbiology and performance become controlled requirements.
Process risk
Critical parameters, cleaning, environment, equipment and in-process controls follow the operation.
Container risk
Compatibility, integrity, function and shelf-life protection are evaluated as part of the product.
Documentation risk
Specifications, records, changes and deviations preserve traceability.
FAQ
Quality questions
Which standards apply?
That depends on category, classification, intended use and market. ISO 22716, ISO 9001 or ISO 13485 may be relevant by scope.
Is every batch controlled?
Each batch follows the specifications and controls defined for that product, with raw-material, process, packaging and review records.
Do ISO references mean certification?
Not necessarily. Certification must be verified against the applicable certificate, scope and validity.
Etternity Dermal
Design quality before manufacturing
We review critical attributes and control strategy from the first project stage.