ppt Fachbereich API



We support you in all life phases of your process and production cycle for the production and purification of herbal, chemical or biotechnological active ingredients and excipients.
From the design of your processes and equipment to the procurement, commissioning and qualification of your production equipment to the optimization of existing processes taking into account GMP and their interfaces to other areas, we are a strong and competent partner at your side.

We are specialists with many years of experience in the operation, design and commissioning of a wide variety of plants and processes from the auxiliary and active ingredient sectors.

We offer the following services within the framework of active substance technology:

API Experts

  • Specialists in manufacturing processes for active ingredients and excipients in plant-based, chemical and biotechnological processes
  • Plant and process design for manufacturing and filling plants as well as secondary equipment
  • Hygiene and cleanroom classes of all types
  • Development and validation of sterilization, disinfection and cleaning processes, CIP, SIP, autoclaving or even production processes
  • Containment experts for High Potent Drugs

Quality Experts

  • Needs-based and risk-based preparation of qualification and validation concepts for investment or also small-scale projects
  • Execution of qualification and validation of facilities and rooms
  • Preparation of all necessary operational documents such as work instructions / SOPs and rationales
  • Product transfer to other production sites and CMOs
  • CSV andy data integrity
  • Preparation of process risk analyses (CPP, CQA, CMA)
  • Change control, deviation and CAPA management
  • Managed QA Services
  • Quality Oversight Services

GMP consulting in the area of API / active ingredients

  • Setup and optimization of GMP systems or QM documentation – adapted for API manufacturers
  • Consulting for current guidelines and on all GMP topics
  • Carrying out self-inspection or even supplier and mock audits
  • Organization and support of inspections by authorities
  • GMP readiness for API manufacturers and their machine suppliers
ppt CEO and Aseptic Expert Gerald Mathe

Mr. Gerald Mathe
is your contact in the area of ACTIVE INGREDIENTS / API