DEVELOPMENT OF COSMETIC PRODUCTS

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

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.