At Enorme Lifesciences, quality isn’t a final checkpoint—it’s built in from the very beginning. For us, quality control is not just a process; it’s a promise. In the nutraceutical industry, where every capsule, powder, or tablet can directly impact someone’s health, quality is non- negotiable. Our approach ensures that every product we manufacture meets the highest standards of safety, efficacy, and compliance before it reaches the market. For us, quality quality is not inspected at the end—it’s an integrated culture that runs through every stage, from raw material sourcing to production and final dispatch.

Why Quality Control Matters in Nutraceuticals

In the nutraceutical industry, products are made for direct human consumption — which makes quality absolutely critical. As these products are linked to people’s health, there is no margin for error. A single contaminant, whether heavy metals, harmful microbes, or pesticide residues, can cause serious harm and erode consumer trust. Poor-quality raw materials can result in ineffective or unsafe products, while inconsistent production can lead to incorrect dosages or unstable formulations.

At our facility, consumer safety is the highest priority, and every measure is taken to ensure products are free from contaminants, carry the correct dosage as stated on the label, and maintain uncompromised purity. Our operations strictly follow FSSAI, GMP, ISO 22000, and HACCP standards, consistently meeting and exceeding the stringent requirements set by these regulatory bodies. By investing heavily in our quality systems, we protect brand integrity and ensure that every product inspires confidence in the market.

Our Quality Control Framework

Our QC framework covers the full production cycle — from raw material procurement to the moment the finished product is shipped. We operate with two dedicated quality departments, each staffed with experts whose sole responsibility is to ensure that every process and activity complies with the quality parameters defined by regulatory and certification bodies. This dual-layered approach ensures absolute consistency, traceability, and accountability at every stage of production.

Our quality control is responsible for checking the quality of raw materials, packaging materials, and finished goods, ensuring they meet all defined standards before approval.

Incoming Raw Material Testing

Every new ingredient — or each new batch of an existing ingredient — that enters our facility undergoes rigorous testing by our Quality Control team. Upon arrival, materials are quarantined in a designated area and are not moved into storage until they have been thoroughly tested and officially approved.

Here’s what we look for:

• Identity: Confirming that the ingredient is exactly what it claims to be.
• Purity: Checking for unwanted substances such as heavy metals, pesticides, or adulterants.
• Potency: Ensuring active ingredient levels meet the required specifications.
• Microbial Safety: Screening for harmful bacteria, yeast, and mold.
• Physical Parameter Testing: Evaluating physical attributes such as appearance, color, odor, particle size, and solubility to ensure consistency and compliance with product specifications.

We work exclusively with validated suppliers and verify every material through both in- house testing and third-party laboratory analysis before granting approval.

Finished Product Testing

Before any batch leaves our facility, it must successfully pass a series of final Quality Control (QC) tests. Our QC team has complete authority to hold — and, if necessary, reject — any product that fails to meet the required standards, whether for physical parameters or chemical parameters.

Throughout production, representative samples are brought to the QC laboratory for in-depth testing against pre-approved specifications. This ensures that by the time the product is ready for release, it meets the highest quality benchmarks.

Here’s what our QC team checks for during Finished Goods Testing:

• Sensory Evaluation: Each product undergoes a detailed sensory assessment, with taste, colour, texture, and smell carefully evaluated to ensure they match the approved product specifications.
• Label Claim Verification: Every nutrient listed on the packaging is tested and verified, ensuring that nutrient levels exactly match what’s printed — no deviations, no compromises.
• Microbial & Heavy Metal Analysis: Comprehensive testing confirms the absence of harmful contaminants, microbial activity, and heavy metals, ensuring the product is completely safe for consumption.

Only after passing every test is a finished product batch approved for release and cleared for distribution. This uncompromising approach ensures that every item reaching the market is safe, compliant, and exactly as promised.

Advanced Analytical Laboratory

Our state-of-the-art analytical laboratory is the backbone of our Quality Control operations. Staffed by highly trained chemists, microbiologists, and quality analysts, and equipped with advanced instrumentation, it delivers precise, reliable, and reproducible results at every stage of testing.

Our facility houses:

• High-Performance Liquid Chromatography (HPLC): For accurate potency testing and quantification of active ingredients.
• UV-VIS Spectrophotometer: For rapid and accurate nutrient quantification.
• Microbiology Suites: For pathogen detection and contamination testing under controlled conditions.
• Sieve Shaker: For particle size distribution analysis.
• Bulk Density & Tapped Density Apparatus: For determining powder flow and compaction properties.
• Moisture Analyzer: For accurate moisture content determination to ensure product stability.
• pH Meter: For precise measurement of acidity or alkalinity.
• Viscometer: For measuring viscosity in liquid formulations.
• Hardness Tester: For assessing tablet breaking strength.
• Friability Tester: For evaluating tablet abrasion resistance.
• Disintegration Tester: For determining the time tablets take to break down in a specified medium.
• Dissolution Tester: For measuring the rate and extent of active ingredient release.
• Leak Test Apparatus: For checking packaging integrity.

With these capabilities, we ensure every product meets or exceeds domestic and international quality benchmarks, supporting our commitment to safety, compliance, and excellence.

Compliance & Certification

We operate in strict adherence to:

• Good Manufacturing Practices (GMP)
• ISO 22000: Food Safety Management
• HACCP: Hazard Analysis and Critical Control Points
• FSSAI

Our facility undergoes regular audits—both internal and external—to ensure ongoing compliance and readiness for client or regulatory inspections.

Traceability & Documentation

Every product is tracked from the moment raw materials arrive until it leaves our facility. Our digital batch record system maintains:

• Supplier details and certificates of analysis.
• Production process logs.
• In-process and final QC test reports and their specification.
• Distribution and delivery records.
• In-House Control Sample Room: A sample from every batch is retained to address potential market complaints or regulatory queries.

This complete chain of custody ensures total transparency and quick response capabilities in the rare event of a recall or investigation.