Where Science Meets Certainty
Every vial that leaves our facility is the product of an uncompromising quality framework — from raw material sourcing through independent third-party verification to final batch release by a Qualified Person.
Deligas Pharma adheres to EU GMP, USP, and European Pharmacopoeia standards across all product lines. Impurity is simply not an option.
International Standards
Good Manufacturing Practice
Our Berlin facility operates under full EU GMP certification, audited and approved by the European Medicines Agency (EMA). Every production run follows validated SOPs with batch records reviewed by a qualified person before release.
United States Pharmacopeia
All active pharmaceutical ingredients and excipients comply with USP monograph specifications. We verify identity, potency, purity, and performance using USP reference standards before any material enters our production environment.
European Pharmacopoeia
Compliance with European Pharmacopoeia standards is mandatory across our entire product range. Our analytical team cross-references every formulation against current EP monographs, ensuring safety and consistency for European markets.
Our Quality Process
Six rigorous stages stand between raw material and the finished product you receive. Each step is independently documented and auditable.
Raw Material Sourcing
Every active ingredient and excipient is procured exclusively from EMA and FDA-audited suppliers. Full certificates of analysis and supplier qualification documents are retained on file.
In-house HPLC Analysis
All incoming materials and finished products are tested on our calibrated High-Performance Liquid Chromatography (HPLC) systems to confirm identity, purity, and potency against pharmacopoeial reference standards.
Sterile Fill-Finish
Injectable formulations are compounded and filled in ISO Class 5 cleanrooms under positive-pressure laminar airflow. Bioburden, particulate counts, and endotoxin levels are tested at every stage.
Third-Party Verification
Before any batch ships, samples are sent to an independent, accredited analytical laboratory. Third-party CoA results must confirm purity ≥ 99% and absence of heavy metals, solvents, and microbial contamination.
QP Batch Release
A Qualified Person (QP) reviews the complete batch record — synthesis report, in-house analytics, third-party CoA, and environmental monitoring data — before issuing the final certificate of release.
Cold-Chain Dispatch
Finished product is stored and transported under validated temperature-controlled conditions. Real-time temperature loggers accompany every shipment to ensure product integrity from facility to destination.
Quality is not a checkpoint — it's the foundation
At Deligas Pharma, quality assurance is embedded into every decision we make — from which supplier we choose, to how we package the final product. We believe transparency, traceability, and scientific rigour are not optional — they are the minimum standard.
Quality FAQ
Yes. Every batch ships with a full Certificate of Analysis (CoA) from our in-house laboratory, plus an independent third-party analytical report. Both documents are available digitally upon order confirmation.
We use HPLC (High-Performance Liquid Chromatography) as the primary method for potency and purity, supplemented by GC (Gas Chromatography) for residual solvents and ICP-MS for heavy metals screening.
All injectable products undergo sterility testing per USP <71> and EP 2.6.1 methods, in addition to bacterial endotoxin testing (BET) per USP <85>. Particulate matter testing follows USP <788>.
Qualified distributors and institutional buyers may request a facility audit. Please contact our team with your organisation's details and audit scope, and we will arrange a suitable visit under standard NDA.
We conduct ICH-compliant stability studies at accelerated and long-term conditions. Ongoing stability data is reviewed quarterly; any out-of-specification finding triggers immediate CAPA before product remains on the market.
Need a Certificate of Analysis?
Reach out to our team to request batch-specific CoA documents, regulatory dossiers, or to discuss a facility audit. We respond within 24 hours.