Why a Robust Quality Culture is Central to Patient Safety

By: Karyn Campbell and Ania Vandyke


Quality assurance forms the core of any successful pharmaceutical manufac turing paradigm. Specifically, a commitment to quality that spans processes,  facilities, and workflows is critical to delivering safe, effective products and  supporting patient outcomes. Establishing a robust, interconnected qual ity system, designed to meet both customer and regulatory requirements,  is crucial to achieving this goal. Ideally, a company’s quality system will be  standardized across sites, updated comprehensively, and geared toward  facilitating continuous improvement. Well-designed quality systems, global  in their scope, incorporate the regulatory standards from all relevant markets  and are designed to identify and address gaps consistently and holistically. 

Centers of excellence help ensure global standardization 

To deliver on customer objectives, contract development and manufactur ing organizations (CDMOs) typically operate across multiple geographical  locations. However, a regional and global approach creates challenges for  companies trying to meet the varying standards of different regulatory  agencies. Centers of excellence can help address these issues by ensuring  a company’s quality system remains globally standardized. As a result,  any improvements to the quality system are implemented worldwide, with  input from the global center of excellence members ensuring cross-site  consistency is upheld. Often, a specific site may be renowned as a center  of excellence for a particular manufacturing capability, or may perform a  dedicated quality function, which is then embedded within the global quality  system. For example, a site dedicated to aseptic filling of sterile drug  products may set the bar for the rest of the company to ensure products  meet the highest standards of quality. 

A transparent regulatory history informs reliability 

A comprehensive overview of a CDMO’s regulatory history can provide an  excellent indication of its overall reliability and commitment to quality. In the  highly regulated industry that is pharmaceutical manufacturing, companies  are inspected numerous times throughout the year by regulatory health  authorities across the globe. Additionally, a robust internal audit program helps companies find and correct potential issues before they impact product  quality and patient safety. Critically, customers expect to see proof of regu latory inspection outcomes and internal audits in the form of certificates of  compliance and will typically conduct their own audits to verify that an appro priate and compliant quality system is in place to assure that the goods and  services they receive meet their precise requirements.  

Addressing product diversity through a multifaceted quality system 

An effective quality system is built of multiple components, each of which  should be clearly defined to avoid any ambiguity. These typically include  management responsibilities, risk management, documentation, change  management, corrective and preventive action (CAPA), and process perfor mance and product quality. Since a CDMO will manufacture and package  many different products for patient use, at a range of different scales and  using a variety of external suppliers, every component of the quality system  should be designed to account for and control this diversity, and should  be supported by a global IT infrastructure. 

Management Responsibilities

A structured management system is crucial to preserving product quality  and safety, since management is responsible for ensuring that products are  fit for their intended use and comply with appropriate regulatory requirements.  As a consequence, management’s responsibilities must be clearly defined.  These should include establishing, implementing, and communicating the  organization’s quality policy; developing policies, procedures, and plans that  define those elements necessary to meet the quality policy in addition to  regulatory and customer requirements; and ensuring that quality policies,  procedures, and instructions are understood, implemented, maintained,  and accessible to the appropriate personnel. 

Management is also responsible for resource management; organization  of training and recruitment of appropriate personnel; establishment and  maintenance of controls related to suppliers and external services providers;  quality planning; and regulatory reporting. A well-designed CDMO will be  able to provide a clear overview of the organization’s management structure,  detailing how this fits within the quality system. Through a comprehensive  understanding of cross-site responsibilities, management should ensure that  both they and their employees are fully aware of the importance of adhering  to and maintaining an up-to-date knowledge of the organization’s  quality policy.

Rish Management

According to ICH guidelines, risk is defined as the combination of the prob ability of occurrence of harm and the severity of that harm.1 To manage  risk, drug development and manufacturing is reliant on effective quality risk  management (QRM) – a systematic process for the assessment, control,  communication, and review of risks to the patient and to the quality of the  drug product across the product life cycle. 

Following initiation of the QRM process, consideration of each element  should be commensurate with the level of risk. This informs improved  decision-making should a quality issue become apparent. Robust QRM can  provide regulatory bodies with greater confidence in a CDMO’s capacity  to deal with risk, a potential benefit of this being that the extent and level  of direct regulatory oversight may be tailored accordingly. 


Clear documentation is crucial to a robust quality system and should meet  established quality standards to effectively manage knowledge. World Health  Organization (WHO) good documentation and quality management prin ciples state that documentation should provide correct, complete, current,  and consistent information to meet customer and regulatory requirements.2 Documentation should also be concise, legible, accurate, and fully traceable. 

Quality documentation may include policy documents to describe require ments that must be met; process documents that detail activities through  which policy requirements are fulfilled; procedural documents explaining the  specific actions necessary to execute a task in a way that produces consis tent results; and guidelines to provide additional information, instruction, or  tools to support various activities in a manner consistent with higher-level  documentation. Additional documents such as forms to record information,  templates to aid document creation, and documentation to summarize  quality meetings are also highly informative. 

It is important that documentation is reviewed and approved by appropriate  individuals, and that any updates are issued with a new revision number to  prevent obsolete documents from use. Additionally, all documentation should  be suitable to meet local requirements. In general, the level of documentation  required will be proportional to the stage of the product life cycle. 

Change Management

Change is an inherent component of the quality system, which necessitates  identifying and implementing appropriate quality innovations and improve ments throughout the product life cycle. To control change, any modification  with the potential to impact quality, safety, or efficacy should undergo a  process of proposal, evaluation, implementation, and review. This includes any change to the product; the equipment, instrumentation, or process  employed to manufacture it; and the facility at which it is produced. Change  management is also applicable to documentation, computer systems,  training, and regulatory filings. 

The underlying principle of change management is to plan, evaluate, approve,  and implement change efficiently. A structured change management process  should be clearly documented and comprise identification and justification  of the change; notification of areas impacted by the change; assessment to  evaluate the impact of the change; implementation of the change, including  appropriate application of change control systems and updates to regulatory  documents if required; and evaluation of the change to confirm the change  objectives were achieved and that there were no unintended consequences  of the change on product quality. 

Corrective and Preventive Action (CAPA)

The FDA states that the purpose of a CAPA system is to collect and analyze  information; identify and investigate product and quality problems; and drive  appropriate and effective corrective and/or preventive action to prevent their recurrence.3 The CAPA process supports continuous process improvements  in quality system metrics, helping to ensure effectiveness and compliance. 

A robust and transparent CAPA strategy is fundamental to maintaining  control. It is used to monitor, measure, analyze, and improve the quality  system through a process of identification, evaluation, investigation, resolu tion, implementation, and assessment of effectivity. Sources of input to the  CAPA system include processes and operations, concessions, quality audits,  quality and service records, product complaints/returns, regulatory inspec tions, vendor qualifications, management review data, and other sources  of quality data. 

Any activities conducted in support of the CAPA process should be fully  documented. Electronic systems provide an easily accessible, global alterna tive to paper-based documentation and can streamline CAPA progression  via automated routing, notification, approval, and escalation. Further advan tages of an electronic CAPA system include superior reporting and analytics,  user-friendly documentation, and streamlined integration with other elec tronic systems. 

Process Performance and Product Quality

An effective process performance and product quality monitoring system is  required throughout the entirety of the product life cycle to ensure safety,  efficacy, and consistent manufacturability for commercialization. This should  be implemented throughout product development to establish a control  strategy for manufacturing; during technology transfer and scale-up activities to further develop the control strategy; across commercial manufacturing to ensure performance within a state of control and to identify improvement areas; and at post-manufacture (e.g., stability evaluation) to guarantee continued regulatory compliance. 

Supply chain and distribution controls also fall within the scope of process performance and product quality monitoring. These include comprehensive testing of materials or consumables provided by third-party organizations, as well as auditing of partners to safeguard product quality and safety. Automated systems for monitoring process performance and product quality promise real-time control and can support more frequent testing. 

A holistic quality culture supports patient safety 

A holistic quality culture is fundamental to assuring patient safety. In practice,  this means that everyone is responsible for quality, not just the quality assurance team, with the quality mindset being demonstrated by the very highest  

leadership levels. An environment that encourages employees to speak up if  they observe anything outside of the quality system that could be detrimental  to a product is vital, as is having adequate resources and support for the qual ity system to proactively respond to any unforeseen deficiencies. Crucially, a well-designed quality system will consider every aspect of the drug development and manufacturing process to deliver a safe and efficacious product  – both on time and within budget.  

Partnering with a CDMO for drug development and manufacture is a tried and trusted approach to assure product safety, but it is essential that customers  vet potential partners for an established quality policy. With our Lake County  sites being used regularly as a training facility for the FDA, AbbVie is recognized as a leader in quality assurance. Our global quality system provides the requisite flexibility to meet the specific requirements of your product, both during product development and commercialization, and our highly experienced teams offer a wealth of knowledge that can help expedite your drug to market.  

Contact us today to discuss your specific CDMO requirements and learn more about how our quality system underpins both clinical and commercial success.

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