Interquim

Making People Better

Quality Policy

Quality

Certification: FDA Approved
Since 1998, our plant has been inspected three times by the FDA, obtaining satisfactory results on all occasions, thereby corroborating our commitment to the highest levels of quality.

The last inspection, at our Sant Cugat del Vall├Ęs plant, was in October 2013.

Our facilities are regularly audited by our clients: pharmaceutical companies operating in regulated markets.

Quality Assurance (QA)
Our quality assurance department oversees compliance with good manufacturing practices (GMPs) and continual improvement in our processes, with the involvement of all Interquim staff.

Our quality system meets GMP requirements, in accordance with the criteria established in chapter II of European Commission Directive 2003/94/EC, US Code of Federal Regulations CFR 21 and the guidelines of the Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

A documentary system based on approved Standard Operational Procedures (SOPs) rules the activities of each of our Departments.

Quality Control(QC)
In the Quality Control laboratory, our experienced team monitors the quality of our active pharmaceutical ingredients, including raw materials, intermediates, process controls and the finished product.

Our Quality Control laboratory works under the strictest compliance with GMP/GLP. All our computer systems and analytical equipment comply closely with FDA regulation CFR 21 part 11.

The analytical methods and specifications applied to our active ingredients are based on the European, US and Japanese pharmacopoeias, as well as ICH guidelines.

Our Quality Control department has a new laboratory fitted with all the analytical techniques to ensure exhaustive control of our active ingredients. The analytical equipment in our laboratory is controlled regularly by validated calibration and maintenance programmes.

The laboratory also has climatic rooms for performing stability studies on our product in line with the conditions established in the ICH guideline Q1A Stability Testing of new Drug Substances and Products.

The Quality Control department manages and supplies our clients with all the analytical standards required to analyse our products.