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InKemia IUCT group counts with authorized facilities by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (Spanish Agency for medicinal drugs and Sanitary Products) to produce pharmaceutical products. The manufacturing and quality control practices performed at InKemia IUCT group are according to GMP guidelines.
We have the following accreditations:
- ISO 9001:2008 certification for the design, research and development of new products, control systems and training for the pharmaceutical, alimentary, chemical and related sectors (Nº SGI 3201316). Certification by Lloyd’s Register
- Authorization by the AEMPS to manufacture and perform quality control in medicinal drugs for human consumption since 2004 (Nº 4155-E)
- Authorization by the AEMPS to manufacture and perform quality control in veterinary medicinal drug since 2012 (Nº 4155-E)
- Authorization by the AEMPS to manufacture and perform quality control in medicinal under research since 2012-(Nº 4155-E)
The activities that we can develop are:
Galenic Development
- Pre-Formulation studies including:
- Chemical and physical characterization of APIs
- Compatibility studies between excipients
- Preservative challenge test
- Anti-oxidative efficacy studies
- Hygroscopicity studies
- Lubrication impact in solid products
- Formulations development
- Formulations optimization
- Formulations for stability
- Comparison of dissolution profiles
- Batch Productions at pilot levels
- Support in technological transfers
Production
- Production of solid, semisolid and liquid (non-sterile) pharmaceutical products.
- Production of medicinal products under research
- Production of veterinary medicinal products
- Support in studies for process validation
Quality Control
- Physicochemical and microbiological control of cosmetic and pharmaceutical products
- Microbiological control of sterile areas
- Development and set-up of analytical methods
- Validation of physicochemical and microbiological analysis methods
- Analytical support in validation of processes and cleaning
Stability studies under ICH conditions
- Product storage according to ICH regulations
- Product testing
- Development of study protocol
- Preparation for the study report
Consultancy
- DMF Development
- Experimental support
Structure and drafting
- Support in applications that require commercial authorization
- Support for GMP implementation
- Support for GLP implementation
Synthesis of APIs
- Chemical and biochemical development and scale up for APIs synthesis
- Validation and scale up studies
- Synthesis optimization
- APIs characterization
- APIs stress test
- Isolation, characterization and synthesis of degradation products
Facilities
- Manufacturing pilot plant (GMP)
- Laboratories for physicochemical quality control
- Laboratories for microbiological quality control
- Laboratories for the chemical development and biochemical synthesis of APIs
Manufacturing Facilities
The manufacturing facilities at InKemia IUCT group include ISO7 and ISO8 rooms for the production of solid, semisolid and non sterile liquid pharmaceutical products. The equipment in these facilities includes “V” mixer, rotating compressor, fine coating machine, blister machine, drying ovens, liquid and semisolid reactor, and laminar flow cabin.
Quality control laboratory
Instrumental analysis techniques:
FT-IR, UV-diode array, UV-VIS, polarimeter, HPLC-MS3, GC-FID, GC-MS, MS, HPLC-UV, HPLC-diode array, atomic absorption (flame+hydride and graphite furnace)
Other equipment and techniques:
Solution test, digesters, drying ovens, moulding, automatic titration, viscometer, hardness testers, disintegration tests, friability tester, microscopes, laminar flow cabins, incubators, filtering systems.
Chemical synthesis laboratory
The equipment includes, among others, solid-phase parallel synthesizer, liquid-phase parallel synthesizer (carrousel system), parallel synthesizer (IR incubator), Lab-Max reactor, flash parallel purification system, centrifugal evaporator, HPLC-MS-NMR (400 MHz).
Biotechnological synthesis laboratory
The equipment includes, among others, thermal cycler, agarose gel electrophoresis equipment, polyacrylamide gel electrophoresis equipment, laminar flow cabin, bioreactor, incubator.