Pharma



GMP in pharmaceutical manufacturing - self-evident, long established and yet dynamic, continuously changing. With knowledge of new and old GMP topics and their regulatory intricacies, Medcycle can provide individual and professional support.

Whether GMP compliance consulting, GAP analysis, risk management, concept introduction or optimization, CAPEX projects (green- or brownfield), qualification of typical pharmaceutical equipment in production and analytics, validation of sterilization and cleaning processes, media fill validation, or inspection preparation.

 - Medcycle has the right solutions for all GMP tasks in the pharmaceutical industry.

A competent and experienced team of experts supports these tasks in all areas of pharmaceutical manufacturing. From pure consulting to holistic or partial project execution to personnel support in the context of onsite execution.

Selected examples of services



• GAP and risk analysis in the sterile filling of pharmaceuticals
  GMP compliance consulting with subsequent process change in aseptic manufacturing, re-qualification, process validation with subsequent media fill's. New creation or modification of SOP's on all relevant topics.

• Establishment or improvement of a quality management system
  Regulatory GMP compliance consulting. Drafting of specification documents such as policies, guidelines and SOP's on all relevant topics in quality management in the areas of manufacturing, analytics or distribution (GDP).

• Qualification of external service providers and suppliers (GMP/GDP)
  Support in the creation of holistic, risk-based concepts up to the qualification/auditing of individual GxP service providers or suppliers at home and abroad.