Quality Assurance (QA)
The facility has developed robust Quality Management Systems (QMS) systems and policies based on cGMP. We provide our clients with the highest quality products and services. QC is governed by the Quality Systems which are applicable to the entire manufacturing site to ensure alignment to the Quality Philosophy. In addition, QC is controlled by a series of SOPs which specifically apply to operations that are unique to QC laboratories.
The Ology Bio Quality Systems (QS) ensure compliance with cGMP Regulations (21 CFR Part 211 and ICH Guidance for Good Manufacturing Practices) for Active Pharmaceutical Ingredients -ICH Q7 and Biologics Regulations, 21 CFR Part 600 by implementing a QMS. Ology Bio’s QMS is ISO 9001 certified for the development, manufacture, and distribution of biologics, pharmaceuticals, and medical devices. Ology Bio’s QMS is defined in high-level programs and procedures classified as corporate SOPs, applicable to the entire Ology Bio organization.