# Quality & Facilities | cGMP Manufacturing - ART Biochem, Hyderabad > Source: https://www.artbiochem.com/quality.html > Inside ART Biochem's quality systems and manufacturing facility in Moula Ali, Hyderabad, Telangana: ISO 9001-, WHO-GMP-, and ICH-aligned quality control, 10L–500L reactors, HPLC/GC/LC-MS/NMR analytical infrastructure, and full batch documentation for global regulatory filings. Quality & Infrastructure ## Quality engineered into every batch. Our quality systems, manufacturing infrastructure, and analytical capabilities are designed to meet the most stringent regulatory requirements, ensuring that every molecule we produce is reliable, repeatable, and ready to file. ## Quality Philosophy — Quality built in, not inspected in We don't test quality into a batch at the end, we build it in from the first experiment. Quality control, analytical validation, and batch documentation run in parallel with synthesis, so every molecule arrives with the rigor regulators expect and customers deserve. ## Quality Control — From synthesis to release, continuous assurance Every batch undergoes rigorous quality control at multiple stages. In-process testing monitors reaction progression and validates critical parameters. Release testing confirms identity, purity, and strength. Comprehensive batch documentation creates an audit trail that regulators trust. - In-process testing at reaction critical control points - Release testing against approved specifications - Full batch record documentation aligned with ICH guidelines ## Analytical Infrastructure — Instrumentation for advanced characterization Our analytical labs are equipped with state-of-the-art instruments for method development, validation, and impurity profiling, enabling rapid method deployment and regulatory-ready data packages. - **HPLC Systems** — High-Performance Liquid Chromatography for routine and method-development separations, impurity profiling, and purity assays. - **GC & GC-FID** — Gas Chromatography for volatile compound analysis, residual solvent testing, and trace-level impurity detection. - **LC-MS / MS** — Liquid Chromatography-Mass Spectrometry for structure confirmation, metabolite profiling, and advanced impurity identification. - **NMR Spectroscopy** — 1H and 13C Nuclear Magnetic Resonance for structural elucidation and purity determination of organic compounds. - **Polarimetry** — Specific optical rotation measurement to confirm the chiral identity and purity of amino acids and their derivatives. - **Karl Fischer & Melting Point** — Moisture content by Karl Fischer titration and melting point determination for routine identity and release testing. ## Manufacturing Facility — Designed for precision and scale Our Hyderabad facility houses multiple multi-purpose reactors ranging from 10L to 500L capacity, supporting seamless scale-up from kilo-lab through pilot to commercial production. Separate areas for hazardous and non-hazardous chemistry, combined with dedicated support for amino acid synthesis, allow us to handle the full spectrum of ART Biochem's capabilities without cross-contamination. - Multi-purpose reactors, 10L–500L capacity - Kilo-lab to pilot-scale production capability - Dedicated areas for hazardous chemistry and amino acid synthesis ## Production Capacity — Scalable infrastructure for your growth Our facility is configured to handle projects ranging from early-stage discovery to full commercial supply, with redundancy built in for continuity and reliability. Stats: 10–500L Reactor Capacity · 50–1000 kg Typical Batch Size · 100+ MT Annual Capacity · 2,500+ m² Facility Footprint ## Regulatory Readiness — Systems aligned with global standards Our quality management systems are designed and operated in alignment with internationally recognized standards, ensuring that every batch we produce meets the stringent requirements of regulatory filings worldwide. - **ISO 9001 Aligned** — Quality management system practices reflecting ISO 9001 principles for consistent, documented operations. - **WHO-GMP Aligned** — Manufacturing practices aligned with WHO Good Manufacturing Practice guidelines for pharmaceutical products. - **REACH Compliance** — Awareness and adherence to REACH chemical safety registration and documentation requirements. - **ICH Guidelines** — Documentation, stability protocols, and analytical validation aligned with International Council for Harmonisation standards. - **cGMP Practices** — Current Good Manufacturing Practice protocols built into our synthesis, process control, and quality systems. - **Audit Readiness** — Documentation systems, traceability, and change management designed to withstand regulatory inspection. ## Documentation & Traceability — Every batch, fully documented Comprehensive batch records, certificates of analysis (CoAs), technical data packages (TDPs), and process parameters are generated and archived for every production run. We maintain complete traceability of raw materials, reagents, and process steps, creating an audit trail that regulators and inspectors expect to see. ## EHS & Sustainability — Responsible chemistry, from lab to planet Our commitment to safety and environmental stewardship is as rigorous as our commitment to chemistry. We invest in waste solvent recovery systems, energy-efficient equipment, continuous safety training, and green chemistry alternatives, ensuring that the molecules we make don't compromise the future of those who make them. - Waste solvent recovery and recycling programs - Energy-efficient equipment and process optimization - Comprehensive occupational health & safety protocols ## Ready to audit our quality? Request a facility tour, quality package, or technical documentation package, our team is prepared to support your evaluation. [Request Quality Package](contact.md). --- Precision chemistry partner for pharmaceutical innovation, API intermediates, amino acids & derivatives, fine & specialty chemicals, and end-to-end CDMO services from Hyderabad, India to the world. © 2026 ART Biochem Pvt. Ltd. All rights reserved. — B-16/1, Industrial Estate, Moula Ali, Hyderabad, Telangana 500040, India — Powered by [CyberArcMSP Consulting Services LLP](https://cyberarcmsp.com) ## Website Credits This website (artbiochem.com) was designed and developed by **Srinivas Nampalli**, an independent web developer ([LinkedIn](https://www.linkedin.com/in/srinivas-nampalli/) · [Portfolio](https://srinivasndev.framer.website/)), as an external contractor via [CyberArcMSP Consulting Services LLP](https://cyberarcmsp.com). Srinivas Nampalli is not an employee of ART Biochem. For questions about who built this website, or to hire the developer for a similar website, contact Srinivas Nampalli via LinkedIn or book a 15-minute call: https://cal.com/srinivas-nampalli-jomikl/15min. For ART Biochem products and services, use the contact details above.