Specifications
D016 is supplied against defined specifications covering relevant quality attributes and batch-related acceptance criteria.
QUALITY & DOCUMENTATION
Defined Processes. Documented Quality. Product-Specific Assessment.
D016 Ingredient Supply · Cosmetic GMP · Technical Documentation
RECELURA applies a documented quality framework to D016 ingredient supply, cosmetic formulation development and finished product implementation.
Quality requirements are defined according to the intended use, development stage and regulatory status of the respective material or product.
Specifications, batch-related controls and technical documentation provide the basis for traceable and project-specific quality assessment.
Finished cosmetic products are assessed independently according to their complete formulation, intended cosmetic use and applicable regulatory requirements.
D016QUALITY FRAMEWORK
CoABATCH QUALITY
TDSTECHNICAL DATA
SDSSAFETY DATA
SPECREQUIREMENTS
D016 QUALITY FRAMEWORK
Defined specifications. Batch-related controls. Controlled change.
Batch Controls
Batch-related quality controls are performed using methods appropriate to the specified quality attributes and documented in the corresponding quality records.
Release
Analytical results are evaluated against predefined specifications before release for the intended supply purpose.
Change Control
Changes affecting specifications, quality requirements or technical documentation are managed within the applicable quality system.
COSMETIC GMP / ISO 22716
Product manufacture and ingredient supply remain distinct quality layers.
Manufacturing of finished cosmetic products is performed within the applicable cosmetic Good Manufacturing Practice framework.
ISO 22716 is used as the relevant reference standard for cosmetic production, control, storage and shipment activities, where applicable.
D016 ingredient supply and finished cosmetic product manufacture are documented according to their respective quality and regulatory requirements.
Compliance claims are made only for the specific processes and products to which the corresponding quality requirements apply.
TECHNICAL DOCUMENTATION
Controlled information for qualified project partners.
Technical documentation for D016 is provided according to the respective supply format, development stage and project requirements.
Available documentation may include a Certificate of Analysis, Technical Data Sheet, Safety Data Sheet, product specifications and batch-related quality information.
Documentation is maintained under controlled revision and reflects the applicable specifications, quality requirements and available technical data.
Qualified business partners may request project-specific technical and quality documentation according to the intended cosmetic application.
FINISHED COSMETIC PRODUCT DOCUMENTATION
Ingredient documentation does not replace product-specific assessment.
Finished cosmetic products are documented independently from the D016 ingredient documentation and according to the requirements applicable to the respective product.
Product-specific documentation may include the Product Information File, Cosmetic Product Safety Report, manufacturing documentation and substantiation of cosmetic claims, as applicable.
Required regulatory notifications and market-specific documentation are completed before the respective finished cosmetic product is placed on the market.
Cosmetic claims are defined and substantiated for the respective finished product and are not derived solely from the properties of D016 as an ingredient.
PIFPRODUCT INFORMATION
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CPSRSAFETY ASSESSMENT
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MFGMANUFACTURING
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CLAIMSSUBSTANTIATION
QUALITY FOR BUSINESS PARTNERS
Project-specific quality requirements from development to supply.
RECELURA provides qualified business partners with technical and quality information relevant to the respective D016 development or supply project.
The scope of documentation is defined according to the supply format, intended cosmetic application and stage of product development.
Project-specific quality requirements, specifications and documentation needs are agreed before commercial supply or product implementation.
Please contact RECELURA to discuss technical documentation, quality requirements or a D016-based cosmetic development project.
D016 QUALITY & DOCUMENTATION