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CIKLab enables you to structure, automate, and track the entire quality control process, from raw material reception and in-process controls to batch release and automated Certificate of Analysis (CoA) generation.
A Strict Regulatory Framework for Nutritional Supplement Manufacturers
Nutritional supplements are food products governed by strict regulations: Directive 2002/46/EC, Regulation 1169/2011 (labeling), Regulation 1924/2006 (claims), positive ingredient lists, dosage limits, and reporting obligations.
For plant-based ingredients, manufacturers must also comply with the Plant Decree of June 24, 2014, which defines authorized plants, the parts that can be used, and their conditions of use.
Quality Control Challenges for Contract Manufacturers (CMO/CDMO)
With a wide variety of raw materials, multiple formulations, specific client requirements, and numerous analytical tests, quality control testing is central throughout the entire process.
The risks are many: microbiological issues, natural or chemical contaminants, plant variability, adulteration, and regulatory compliance.
On top of that, the diversity of dosage forms (capsules, tablets, powders, liquids, gummies, sticks, etc.) adds complexity, as each requires specific checks: weight, uniformity, hardness, disintegration, and sealing.
In the food supplements contract manufacturing industry, multi-client management, diverse formulas and dosage forms, complex manufacturing processes, and multiple quality requirements make quality control difficult to structure and ensure reliability.
CIKLab provides concrete solutions to the main challenges
Each client has their own specifications with technical requirements, dedicated control plans, and specific acceptance criteria. Managing these requirements manually increases the risk of errors, formula confusion, and non-compliance.
Dietary supplements require rigorous controls at each step: verification of raw materials (identity, active ingredient assays, contaminants), in-process monitoring (homogeneity, assays, critical parameters), and finished product analysis before release.
Capsules, tablets, powders, liquids, gummies, stick-packs… each dosage form requires its own controls: unit weight, hardness, friability, disintegration time, seal integrity, homogeneity. This diversity multiplies the parameters to monitor.
Dietary supplement regulations require complete traceability and detailed certificates of analysis for each client. Audits (clients, certifications, health authorities) require comprehensive documentation that is instantly accessible.
Discover how CIKLab can transform quality control management for your contract manufacturing business
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In the dietary supplement contract manufacturing industry, each produced batch incorporates raw materials and manufacturing intermediates that have already been tested. Contract manufacturers must guarantee the sanitary compliance of finished products without necessarily retesting all parameters already verified upstream.
With CIKLab, create a true traceability chain that automatically transfers all test results from raw materials to finished product batches.
The time spent producing and verifying certificates of analysis, as well as integrating raw material results, slows down batch release and increases the risk of errors.
With CIKLab, automatically transfer your raw material results to finished products, secure your data, and save valuable time!
Transform your quality control: simple, fast, and stress-free with CIKLab!
✓ Start 14-Day Free Trial