Quality
Control is part of the product
Quality is not a final step: it is verified in raw materials, throughout the process and in the finished product.
Quality
Raw material, process and finished product
Quality is not a final step: it is verified in raw materials, throughout the process and in the finished product.
Specific criteria and supporting documentation are defined per product and format.
- Incoming raw material review
- In-process controls during production
- Finished product verification
- Documentation and batch traceability
Control and documentation
Procedures that hold the process together
We work under control and documentation procedures aimed at strengthening Good Hygiene and Manufacturing Practices, material traceability, process standardization and continuous improvement.
01Control+
Parameters defined and verified at every stage of production.
02Documentation+
Records backing what was executed in raw materials, process and finished product.
03Material traceability+
Identification of inputs and their link to every batch produced.
04Process standardization+
Written procedures so the same product is made the same way every time.
05Good Hygiene Practices+
Cleanliness, order and personnel handling conditions inside the areas.
06Good Manufacturing Practices+
Operating criteria applied to the design and execution of production.
07Continuous improvement+
Periodic review of procedures and results to adjust what is needed.
Quality in process
Quality is not only checked at the end
It is controlled throughout the process, from raw material receiving to finished product storage.
- 01Raw material receiving
- 02Identification and document review
- 03Storage
- 04Weighing
- 05Blending
- 06In-process controls
- 07Filling and packing
- 08Finishing
- 09Finished product inspection
- 10Release
- 11Storage
Suppliers and raw materials
Quality starts with the raw material
Supplier selection considers the technical and quality documentation applicable to each raw material, as appropriate for the type of ingredient.
- 01Certificates of analysis
- 02Technical specifications
- 03Supplier documentation
- 04Ingredient identity and characteristics
- 05Storage conditions
- 06Batch traceability
- 07Assessment of received material
Not every document applies to every material: the scope is defined as appropriate for each ingredient and project.
Controls during production
Parameters verified by product type
During production we verify the parameters applicable to each product and format.
Finished product
Finished product assessment
Depending on the characteristics and requirements of each product, the following analyses may be performed or requested:
Physicochemical
Product properties against its approved specification.
Bromatological
Nutritional composition tied to the product's declaration.
Microbiological
Parameters applicable to the product type and presentation.
The scope of testing is defined per product; analyses may be performed in house or requested from external laboratories, as appropriate.
Traceability
Every batch has a history.
Traceability makes it possible to reconstruct the documented path of every batch, from the raw materials used to the controls and records generated during manufacturing.
Batch traceability
The link between inputs, process and finished product.
Production records
Documentary evidence of what was executed in each batch.
In-process controls
Verifications at the critical stages of manufacturing.
Deviation management
Identification and recording of anything outside specification.
Corrective actions
A documented response to a detected deviation.
Continuous improvement
Periodic review of procedures and results.
Documentation makes it possible to reconstruct how a batch was produced: inputs used, process parameters and checks performed.
That gives your brand technical backing in front of its own customers and sales channels.
- Batch identification on the finished product
- Process records and associated verifications
- Approved specification as the production reference
Manufacturing standards
NOM-059
NOM-059-SSA1-2015 · Good manufacturing practices
Designed around pharmaceutical manufacturing standards
Celion Labs is designed to comply with the principles and requirements of Mexico's NOM-059-SSA1-2015 standard for good manufacturing practices in pharmaceutical facilities.
This approach incorporates demanding criteria for infrastructure, hygiene, process control and operational protocols aimed at maintaining consistency and quality throughout the manufacturing process.
Scale matters. Standards matter too.
Because producing more does not necessarily mean producing better. True manufacturing capability combines infrastructure, control and consistency.
Regulatory compliance
Prepared to operate across different markets.
Celion Labs addresses regulatory requirements according to the product type and the destination market.
Mexico
COFEPRIS
Aviso de Funcionamiento with COFEPRIS
An administrative filing that applies to the establishment, in line with the applicable Mexican regulation.
United States
FDA
FDA-registered facility
Facility registered with the U.S. Food and Drug Administration for the applicable activities. Facility registration does not constitute product approval or FDA endorsement.
Colombia
INVIMA
Product sanitary registrations with INVIMA
This status applies to specific products holding sanitary registration, not to the establishment as a whole.
Regulatory requirements vary according to the product, formulation, category and destination market.
Supporting documentation for each project is shared during its review: we claim no scope without evidence.
Next step
Request the technical detail for your project
We define the applicable controls for your product together with you.
Develop Your Product