Quality Manual

A detailed Quality Manual covers all relevant aspects

Richter-Helm BioLogics has described its quality standards for all business processes in a comprehensive quality manual.

Here is a synopsis:

1.1 Mission Statement

Richter-Helm BioLogics is a best-in-class biopharmaceuticals company that professionally handles projects through all of their steps, from developing active biopharmaceutical ingredients to supplying the market with registered finished products. Both full in-house development and contract manufacturing of active biopharmaceutical ingredients play important roles.

1.2 Quality Policy

The team of Richter-Helm BioLogics strives to continuously improve our services, internal standards, and business systems for meeting the expectations of both external and internal clients and complying with relevant regulatory requirements (see section 1.3) throughout each product’s lifecycle. We communicate our quality policy to the organization and translate it into internal standards that are consistently taught, understood, applied, and followed.

1.3 Regulatory Background

The contents of this quality manual are based on national and international medical regulations including US GMP (FDA): 21 CFR 210, 211 cGMP, the ICH Quality Guidelines, the EU GMP Guidelines, AMWHV, AMG, and DIN EN ISO 50001. It includes all relevant information on the quality standards for every process at Richter-Helm BioLogics―either for specific sites or across all three company sites as applicable. The section headings of this manual include bracketed numbers that refer to site master file content according to EU GMP Part III on GMP-related documents.

1.4 Scope and Objectives

This quality manual specifies the procedures and documents used by Richter-Helm BioLogics to meet regulatory requirements and demonstrate the ability to consistently develop, transfer, produce, and test drug substances and intermediates. It includes a strong commitment to providing related services to comply with the specifications of both the customer and Richter-Helm BioLogics, always with the aim of ensuring the full satisfaction of both internal and external customers. Another important aim is to ensure conformance to all applicable regulatory requirements, including continual improvement and prevention of non-conformances.