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Quality Systems 2017-11-15T02:40:33+00:00

Quality Systems

 

The facility has developed robust QC 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 Quality Management System (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.

These documents include such SOPs as Deviation Handling, Corrective and Preventive Actions (CAPA), Change Control, Validation Policy, Environmental Monitoring Program, Calibration Program, Equipment Identification and Control. SOPs describing activities and processes specific to the ADM facility are described in site-specific SOPs.  These SOPs cover such items as Environmental Monitoring Sampling of Classified Areas, Cleaning and Disinfection, Equipment Operation and Maintenance, Personnel Gowning, Personnel and Material Flow.  QMS is comprehensive and provides processes and procedures necessary to perform all core QMS elements including:

  • Management review
  • Document management and control
  • Deviations
  • Corrective and Preventive Action (CAPA)
  • Change Control
  • Supplier selection and management
  • Quality Agreements
  • Quality audits
  • Employee training
  • Calibration
  • Customer complaint handling

The ADM facility uses a combination of 21 CFR Part 11 compliant eQMS systems to manage the QMS processes.  The selection of the eQMS systems was based on the degree to which each system meets performance expectations for each function, cost, and the ease of implementation.

Quality uses a series of 21 CFR Part 11 compliant software solutions to manage Quality activities including:

  • Document Management and Control
  • Deviation, CAPA, Change Control, Investigations, Audit Management
  • Equipment Calibration and Maintenance Management
  • Training Management
  • ERP, Inventory Management, and Control
  • Laboratory Information Management Systems
  • Environmental Monitoring

Ology Bio has an established Quality Management System (QMS) that is compliant with:

  • 21 CFR 210 and 211 (Drugs)
  • 21 CFR 600, 606 and 610 (Biologics)
  • 21 CFR 820 (Medical Devices)
  • 21 CFR 1270 and 1271 (Human Cells, Tissues and Cellular and Tissue-Based Products)
  • ISO 9001 (General Quality Systems)
  • ISO 13485 (Medical Devices)

Ology Bio’s QMS is compliant with 21 CFR 210/211 (GMP of Pharmaceutics), 820 (Quality System Regulation).  Ology Bio QMS also received ISO 9001 and 13485 certifications in 2012.

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