Manufactured Under GMP Pharmaceutical Standards
Pharmacros products are produced in France in manufacturing facilities that operate under Pharmaceutical Good Manufacturing Practice (GMP) standards, certified by ANSM (The French National Agency for Medicines and Health Products Safety) to produce medicines, a set of rigorous requirements that govern every aspect of how our products are made. From the moment raw materials arrive at the facility to the moment a finished product leaves it, every step is documented, controlled, and verified.
GMP is not simply a certificate on a wall. It is a living system embedded in our daily operations. It means that the manufacturing premises meet strict hygiene and environmental standards, the equipment is regularly qualified and calibrated, and the personnel are continuously trained. It means every batch that Pharmacros is producing is manufactured according to a validated manufacturing process and released only after passing a full suite of quality checks. It means that if something does not meet specification — at any stage — it does not move forward.
This framework gives something that no marketing claim alone can provide: a verifiable, auditable guarantee that what is stated on the label reflects what is in the product, and that the product has been made in a clean, controlled, and consistent manner.
Stability Testing to ICH Standards: Six-Month Accelerated Studies
A supplement that meets quality specifications on the day it is manufactured is only part of the story. The more important question is whether it still meets those specifications on the day it will be consumed, which may be months or even more than a year (shelf-life for nutrient supplements is 24 months).
To answer that question with certainty, Pharmacros products undergone accelerated stability testing in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, specifically ICH Q1A(R2). This is the internationally recognised framework used by the pharmaceutical industry to predict how a product ages and to establish evidence-based shelf life.
In an accelerated stability study, products are stored under elevated temperature and humidity conditions — typically 40°C and 75% relative humidity — for a period of six months. These conditions are designed to simulate the stresses a product may encounter over its intended shelf life in an accelerated, time-compressed manner. At defined intervals — typically at zero, one, two, three, and six months — samples are pulled and subjected to comprehensive analysis.
The parameters tested include chemical potency (to confirm active ingredient levels remain within specification), physical appearance, colour, odour, pH where applicable, microbial counts, and any product-specific attributes relevant to the formulation. The data generated from these time points is then used to establish or confirm the product's shelf life, giving our customers confidence that the stated expiry date is not an estimate but a science-backed commitment.
This level of stability testing goes significantly beyond what is required for food supplements under standard regulations.
Preservative Efficacy: Challenge Testing per the European Pharmacopoeia
For liquid and semi-solid formulations, ensuring microbiological safety over time requires more than simply adding a preservative to the formula. It requires demonstrating, through controlled scientific challenge, that the preservative system is genuinely effective against a defined panel of microorganisms under real-world conditions.
This is precisely what we do. All relevant products are subjected to Preservative Efficacy Testing — commonly known as the Challenge Test — conducted in full compliance with the European Pharmacopoeia (Ph. Eur.), the official quality standard for medicinal and related products across Europe.
The test works by deliberately introducing specified microorganisms — including bacterial strains such as Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coli, as well as fungi such as Candida albicans and Aspergillus brasiliensis — directly into the product at a defined inoculum level. Samples are then incubated and monitored at set intervals over a period of up to 28 days. For a product to pass, the preservative system must demonstrate a specified logarithmic reduction in the viable count of each organism within the defined time points, proving it can effectively prevent microbial proliferation throughout the product's shelf life.
Meeting the Ph. Eur. acceptance criteria means that our products are protected against microbial contamination not just in theory, but in practice — under conditions that reflect realistic exposure during use. This is particularly important for products that are opened, closed, and used repeatedly over a period of up to 30 calendar days.
What This Means for Our Customers
At Pharmacros, we recognize that the world of food supplements can feel opaque. Promises are easy to make; evidence is harder to produce. Our approach is to let science speak.
Every product we manufacture is built on validated formulations, produced in pharmaceutical-grade facilities, tested for stability across its shelf life, and proven to maintain its microbiological integrity from first use to last. These are not optional extras. They are the standard we apply to every single product that carries the Pharmacros name.
For the consumer to choose our supplements, is not choosing based on packaging or marketing alone. Is choosing a product that has been put through its paces rigorously, transparently, and in accordance with the highest standards the industry has to offer.
That is Pharmacros definition of quality.
Pharmacros Team
