Quality Assurance at a Glance

Quality Assurance is Integral to Every Project

GMPs govern all project stages from clinical phases I, II, and III to commercialization, including production, quality control, and storage of biotechnological intermediates and Active Pharmaceutical Ingredients.

Every clinical-phase customer project is monitored by an in-house quality assurance expert of Richter-Helm BioLogics who is assigned to the project team.

We follow established technology transfer procedures (protocols and records). For each new clinical-phase project, a project-specific validation master plan is issued, submitted to the relevant authority, and assessed together with the German Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI).

The master validation plan is updated with each successive clinical phase. It provides a complete overview of each validation and qualification status finding on everything from equipment and facilities to the process itself and the analytical testing procedures used.

Our quality assurance team makes sure that:

  • Staff receive thorough training in each manufacturing process and the use of GMP procedures.
  • Equipment and facilities are qualified for their intended uses.
  • Analytical methods are validated according to ICH guidelines.
  • Processes are validated for each clinical phase in accordance with current international guidelines.

We provide support and required information for compiling INDs and IMPDs and subsequently for the dossier.

Richter-Helm Biologics also maintains an experienced team whose members work in the front and back offices to accompany and facilitate the work of customer auditors and official inspectors.

“We have very high QA expectations … and Richter-Helm BioLogics has acquired an excellent reputation in this respect.”

(customer)

Our quality system is regularly maintained, improved, and updated to ensure compliance with new regulations

The following recurring work activities are continually improved:

  • The CAPA system
  • Product quality and annual product reviews
  • Data trending and tracking
  • Quality management reviews
  • Change control