Substance purity is a critical factor for the safety and stability of any pharmaceutical product. The reliability of the final medicine — and the absence of risks for distributors — depends on the quality of raw materials and the accuracy of laboratory procedures. Our Purity Verification Workflow follows Health Canada requirements and international standards. At every stage — from receiving raw materials to releasing each batch — we maintain transparency, predictability, and proven quality.
Receiving raw materials: full compliance with Canadian GMP
In Canada, pharmaceutical production is regulated by GMP — Good Manufacturing Practices. These are the rules that ensure medicines, such as BPC1 (Body Protection Compound (BPC-157), are produced safely and consistently. According to GMP, a manufacturer must prove that the raw material is exactly what it claims to be, that it meets the declared specifications, and that transportation conditions have not compromised its quality.
We never accept raw materials automatically. Each shipment is checked step by step: origin → documentation → Certificate of Analysis (CoA) → supplier history → supplier’s GMP compliance → shipping conditions (including temperature logs and packaging integrity).
If any parameter raises doubts, for example in NPP1 (Nandrolone (NPP), the material is immediately placed under quarantine. It is released for manufacturing only after independent laboratory confirmation. This approach reduces the risk of situations where paperwork looks correct, but the true purity or stability of the material does not meet requirements.
Laboratory testing: what we check and how we do it
Canadian regulators require that all analytical methods be validated — meaning they must be proven to provide accurate, reliable results. These requirements are set out in international ICH documents. In simple terms:
- ICH Q2 defines how analytical methods for testing purity, impurities, and stability must function;
- USP (United States Pharmacopeia) and EP (European Pharmacopoeia) contain standard tests for pharmaceutical substances.
We use these approaches because they are recognized by Health Canada and international markets. What we analyze:
- Chemical purity — how much active substance is actually present;
- impurities — reaction byproducts, residual solvents, trace metals, degradation products;
- microbiological purity — total microbial count and absence of unwanted flora;
- sterility — for substances that must be free from viable organisms;
- physicochemical properties — pH, viscosity, solubility, and other parameters affecting stability and manufacturability.
Our validated analytical methods include HPLC/UHPLC for purity, GC-MS and LC-MS for trace impurities, UV spectroscopy for identity, Karl Fischer titration for moisture content, and microbiological tests for purity and sterility.
When results are out of spec: how we handle deviations
OOS (Out of Specification) and OOT (Out of Trend) refer to results that fall outside limits or deviate from the usual data pattern. Health Canada requires that each such case be investigated — not simply retested. Our approach is as follows:
- the batch is immediately blocked;
- a formal investigation is initiated according to SOP;
- instruments, reagents, sample stability, storage conditions, and the method are checked;
- all actions and conclusions are documented;
- a CAPA plan (Corrective and Preventive Actions) is developed.
Only after the root cause is identified can a repeat test be performed. This prevents unpredictable deviations from reaching the final product.
Documentation: ALCOA+ made simple
ALCOA+ is a data-integrity principle required by Health Canada. It means that data must be Attributable, Legible, Contemporaneous, Original, Accurate — and also complete, consistent, enduring, and available.
We follow these principles by using electronic logs and a LIMS system, automatically recording every correction, making deletion or substitution of records technically impossible, and maintaining a full audit trail for inspections and partners.
For distributors, this means quality is verified by evidence — not by declarations.
Final purity approval: independent QA decision
QA (Quality Assurance) is an independent unit that does not report to production and is responsible for the final batch release. The workflow is straightforward:
- QA receives the full data package.
- verifies each test for correctness.
- assesses risks related to impurities or instability.
- compares results with the dossier and pharmacopeial standards.
- issues a decision to release or reject the batch.
Without QA approval, the product cannot enter manufacturing or reach the market. For distributors, this is a key trust factor: an independent expert confirms every aspect of quality.
If you’re looking to expand your portfolio with high-quality, fully compliant pharmaceutical products, we invite you to partner with us as a distributor. Our verified processes and consistent purity standards ensure reliability you can trust. Let’s build a strong partnership based on quality and transparency.