InKemia IUCT group counts with authoruized facilities by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Sanitarios (Spanish Agency for medicinal drugs and Sanitary Products) to perform control of cosmetic products. The quality control practices performed at InKemia IUCT group are according to GMP guidelines.
We have the following accreditations:
- ISO 9001:2008 certification by Lloyd’s Register for the design, research and development of new products, control systems and training for the pharmaceutical, alimentary, chemical and related sectors (Nº SGI 3201316).
- Authorization by the AEMPS to perform quality control in cosmetic products since 2007 (Nº 4155-E).
The activities that we can develop are:
Desenvolupament galènic
- Pre-Formulation studies including:
- Chemical and physical characterization of APIs
- Compatibility studies between excipients
- Effectiveness studies of antimicrobial preservation
- Effectiveness studies of antioxidants
- Hygroscopicity studies
- Lubrication impact in solid products
- Formulations development
- Formulations Optimization
- Stability Formulations
- Comparison of dissolution profiles
- Batch Productions at pilot levels
- Support in technological transfers
Manufacturing
Support in Studies for process validation
Quality control
- Physicochemical and microbiological control of cosmetic products
- Start-up and development of methods for analysis
- Validation of physicochemical and microbiological analysis methods
- Analytical support in validation of processes and cleanliness
Stability studies under ICH conditions
- Product storage according to ICH regulations
- Product testing
- Development of study protocol
- Drafting of study report
Consultancy
- Support in applications that require commercial authorization
- Recommendation for GMP establishment
- Recommendation for GLP establishment
Synthesis of APIs
- Chemical and biochemical development and scale up for APIs synthesis
- Validation and scale up studies
- Synthesis optimization
- APIs characterization
- Isolation, characterization and synthesis of impurities and 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 análisis 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.