Rotachrom staff is well-skilled in quality assurance, risk management, Good Validation and Qualification Practice in order to apply and implement standard GMP methodology within the commissioning procedure and comprehensive technology transfer as well.
Rotachrom applies GMP principles in technology and method development (in-house pilot demonstration and confirmation manufacturing and analysis), based on approved Standard Operating Procedures, Technical Agreements and User Requirement Specifications.
Each system are qualified by the most relevant guidelines (ISPE, PIC, EDQM, etc) and risk assessment through Factory Acceptance Tests and also on-site functional and integration testing. (URS, DQ, IQ, OQ and PQ documentation are always included in the standard project package)
Rotachrom has the ability to support your cleaning validation program, being fully compliant with the regulations by intelligent hardware components, smart surface materials, well-designed maintenance and cleaning documentation in order to minimize cross-contamination and mix-up of your products.
Software applications and design-freeze computerized systems involved in the technology development, scale-up process, pilot and full-scale manufacturing are validated according to the GAMP5 framework.
Rotachrom Subject Matter Experts have fundamental knowledge in state of the art QbD (Quality by Design) and Design Space (DS) concepts and principles, so your technology transfer protocols and reports will be well-designed, comprehensive and eloquent, supporting your uncompromising compliance during your vendor audits and regulatory inspections.