Quality Chemicals’ facilities are designed essentially for the following purposes:
Chemical synthesis, especially of inorganic products.
Distilling a great variety of chemical products.
Process control and analysis.
Our production facilities feature:
Versatility, which allows us to manufacture many different types of products (multi-purpose plant).
* Different reaction capacities (from kilos to tonnes).
* Target products: salts, acids, solvents, synthesis intermediates, ready-to-use products, etc.
* Equipment: stainless and enamelled reactors, distillation columns, dryers and all the tools suited
to specific needs.
* Quality management based on fulfilment of SOPs (Standard Operating Procedures). This system
ensures the traceability of the product throughout the manufacturing process.
GMP Plant
This plant has been operating since 2004 and complies with GMP guidelines ICH-Q7 – EU-GMP part II.
It mainly produces excipients and API for the pharma, veterinary and biopharmaceuticals industries.
However, it also manufactures nitrates, acetates, phosphates and sulphates for other industrial
applications such as foodstuffs and personal care.
In 2015 we earned Spanish Agency of Medicines and Medical Devices authorisation to produce API.
We can supply any of our products manufactured under GMP conditions.
These GMP products are usually used by pharmaceutical, biopharmaceutical
and veterinary companies and can be used as:
• Reagents
• Starting material
• Excipients
• API
They are produced under the European GMP Guide for the manufacturing of drug products part II,
active substances (ICH Q7). We also offer multicompedial products: the product can be supplied
in compliance with the quality standards of individual pharmacopoeias, a combination of several of
them or even without a monograph in any pharmacopoeia.
With our GMP grade you get the following benefits:
• Fast track to market, fast registration
• High quality and safe raw materials; easier and safer to get process approval
• Dossiers ready-to-use, no need to develop test methods or evaluate stability data
• Compliance with international regulatory standards
With the GMP grade we offer:
• Strict working conditions following ICH guideline Q7-part II
• Customised solutions and tailored packaging to meet your needs
• Change control
• Full traceability
• Supplier audits
• Dedicated regulatory support
• Comprehensive dossiers in the international CTD format, acc. to ICH Module 3.
Please find more details about documents at “Supporting Documents” at Support in the Menu.
We have been regularly inspected by the Spanish Agency of Medicines and Medical Devices
(AEMPS) since 2015, which means our quality assurance system is regularly monitored and
audited by this authority. Our quality system is also monitored by 30 audits per year by our pharma,
cosmetics and food industry customers.