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Third-Party Testing Program Expanded with New ISO 17025 Lab Partnership

SM
Dr. Sarah Mitchell
Director of Quality Assurance
September 12, 20257 min read

Transparency and quality assurance have been core pillars of Alise Pharma since day one. Today, we are announcing a significant expansion of our third-party testing program through a new partnership with an additional ISO 17025 accredited laboratory. This partnership doubles our independent testing capacity and enables us to provide batch-level Certificates of Analysis for every product we sell — a level of transparency that is still uncommon in the supplement industry.

The supplement market operates under less regulatory oversight than pharmaceuticals, which means the burden of quality assurance falls heavily on brands themselves. Independent studies have repeatedly found that a significant percentage of supplements on the market do not match their label claims — some contain less active ingredient than stated, others contain undisclosed contaminants, and a few contain ingredients not listed on the label at all. Our expanded testing program is designed to give our customers absolute confidence that what is on the label is what is in the bottle.

What ISO 17025 Means

ISO/IEC 17025 is the international standard for testing and calibration laboratories. It is published by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), and it specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. When a lab holds ISO 17025 accreditation, it means their testing methods, equipment calibration, quality management systems, and personnel qualifications have been independently audited and verified.

This accreditation is not a one-time achievement. ISO 17025 labs undergo regular surveillance audits and full re-assessments to maintain their accreditation. They must participate in proficiency testing programs, maintain meticulous documentation of every analytical procedure, and demonstrate measurement traceability to national or international standards. In practical terms, this means that test results from an ISO 17025 lab carry a level of credibility and reproducibility that far exceeds results from non-accredited labs.

Not all third-party testing is created equal. Many supplement brands claim to use third-party testing but rely on labs that lack recognized accreditation. We require ISO 17025 accreditation as a minimum standard for any laboratory that tests our products, because our customers deserve results they can trust.

The New Lab Partnership

Our new lab partner is a US-based analytical testing laboratory with ISO 17025 accreditation from a nationally recognized accreditation body. They specialize in dietary supplement and nutraceutical testing, with particular expertise in heavy metals analysis, pesticide residue screening, and microbiological testing. Their facility is equipped with inductively coupled plasma mass spectrometry (ICP-MS), high-performance liquid chromatography (HPLC), and gas chromatography-mass spectrometry (GC-MS) instrumentation — the gold standard analytical tools for supplement quality testing.

This partnership supplements our existing relationship with our primary testing lab, which we have worked with since Alise Pharma's inception. Having two independent labs allows us to cross-validate results for added confidence, reduce turnaround times during peak production periods, and maintain testing capacity even if one lab experiences equipment downtime or scheduling constraints. It also provides a layer of redundancy that ensures our testing program is never bottlenecked.

What Gets Tested

Every batch of every Alise Pharma product undergoes a comprehensive testing panel that covers three critical areas: identity and potency, purity, and contaminant screening.

Identity and potency testing verifies that the product contains the correct ingredients at the amounts stated on the label. Using HPLC and other chromatographic methods, the lab confirms the identity of each active ingredient and quantifies its concentration. This ensures that a product labeled as containing 200 mg of magnesium glycinate per serving actually delivers that amount — not 150 mg, not 250 mg, but the exact labeled dose within tight analytical tolerances.

Purity testing screens for adulterants, undeclared ingredients, and degradation products. This is particularly important for botanical extracts and amino acid supplements, where adulteration with cheaper substitutes is a known industry problem. Our purity testing uses reference standards and spectral libraries to confirm that each ingredient is genuine and free from substitution.

Contaminant screening covers heavy metals (lead, mercury, cadmium, arsenic), pesticide residues, microbiological contamination (total aerobic count, yeast, mold, E. coli, Salmonella, Staphylococcus aureus), and solvent residues where applicable. We test against the strictest available standards, including California Proposition 65 limits for heavy metals, which are among the most conservative thresholds in the world.

Batch-Level Certificates of Analysis

With our expanded testing capacity, we are now able to generate and publish batch-level Certificates of Analysis (CoAs) for every product we sell. A CoA is a detailed document that reports the actual test results for a specific production batch, including the test methods used, the acceptance criteria, and the measured values. It is the most granular level of quality documentation available for a consumer product.

Every Alise Pharma product now includes a QR code on the packaging that links directly to the CoA for the specific batch you purchased. Simply scan the code with your phone camera, and you will see the complete test results — identity confirmation, potency measurements, heavy metals levels, microbiological results, and more. No other supplement brand we are aware of provides this level of batch-specific transparency at scale.

We believe this transparency should be the industry standard, not the exception. If a brand is confident in the quality of its products, there is no reason to hide the test results. Our CoA program is our way of putting our quality claims on the record, batch by batch, for anyone to verify.

Our Ongoing Commitment to Transparency

The expanded testing program is part of a broader commitment to transparency that extends across every aspect of our business. We publish full ingredient lists with exact doses — never hiding behind proprietary blends. We disclose our manufacturing partners and their GMP certifications. We publish the results of our clinical studies regardless of outcome. And now, with batch-level CoAs, we are making our quality testing results available to every customer.

We believe the supplement industry is at an inflection point. Consumers are becoming more discerning, more educated, and less willing to accept vague quality claims. Brands that invest in genuine quality assurance and radical transparency will earn long-term trust. Those that do not will be left behind. Alise Pharma intends to lead this shift, and our expanded testing program is one more step in that direction.

Key Takeaways

  • Alise Pharma has partnered with a second ISO 17025 accredited lab, doubling independent testing capacity.
  • ISO 17025 is the international gold standard for laboratory competence, requiring regular audits, proficiency testing, and measurement traceability.
  • Every batch is tested for identity/potency, purity (adulterant screening), and contaminants (heavy metals, pesticides, microbiological).
  • Batch-level Certificates of Analysis are now accessible via QR code on every product, providing complete test results for the specific batch purchased.
  • Heavy metals testing uses California Proposition 65 limits — among the most stringent thresholds in the world.
SM
Dr. Sarah Mitchell
Director of Quality Assurance at Alise Pharma

Dr. Sarah Mitchell leads Alise Pharma's quality assurance program, including third-party testing, GMP compliance, and regulatory affairs. With a Ph.D. in analytical chemistry from UC Berkeley and eight years of experience in pharmaceutical quality control, Sarah brings rigorous scientific standards to every aspect of the company's quality program. She is an advocate for industry-wide transparency and regularly publishes on best practices in supplement quality testing.