In the highly regulated pharmaceutical industry, effective quality management is crucial for ensuring that products meet safety and efficacy requirements. The right combination of processes, procedures, and policies helps pharma companies manage and improve product quality from development to distribution. However, quality initiatives can fail to deliver results if, as is often the case, quality management is performed using manual tools such as paper, spreadsheets, and network drives to create, manage, and track quality processes.
Quality is a Serious Issue In Pharma
The US Food and Drug Administration (FDA) has identified quality issues as the primary reason for drug shortages, including inadequate control of the manufacturing process or raw materials. Other things that affect quality include inadequate testing or release procedures and lack of training and documentation. For example, inadequate or incomplete documentation can result in difficulties in tracing the manufacturing process, testing results, and deviations from normal procedures.
A quality management system can help with these challenges by providing a place to set up the processes and workflows required to ensure employees are managing their work properly. By automating workflows, issues can be identified sooner, and in many cases, eliminated completely. In addition, analytics and reporting will not only help management quickly recognize issues but demonstrate how effective processes can ensure products meet regulatory requirements and are safe and effective for use by patients.
The 7 Core QMS Processes
With the increasing digitalization of the industry, mid-sized pharma companies are now embracing the use of cloud-based, automated and integrated quality management systems to optimize their operations, improve quality, and level the playing field with larger pharma companies.
A QMS provides several essential modules (or capabilities) to help achieve these goals, including:
- Deviation Handling: Deviation handling refers to the process of managing and documenting any deviations from the standard operating procedures (SOPs), manufacturing and packaging approved processes, or approved prevalidated testing procedures. This process is critical to ensure that products are produced according to predetermined specifications and meet quality requirements. An example of a deviation could be an unexpected power outage during manufacturing, leading to the loss of temperature control in the production area. The deviation would be documented, and corrective actions would be taken to minimize the impact on the quality of the product.
- Corrective and Preventive Action (CAPA): CAPA is a systematic approach to identify, investigate, and solve quality problems. It involves identifying the root cause of non-conformances, taking corrective action to eliminate the problem, and implementing preventive measures to prevent recurrence. An example of a CAPA process is when a batch of a drug fails quality testing due to contamination. The manufacturer will investigate the root cause, implement corrective action, such as disposing of the contaminated batch, and prevent recurrence by updating the manufacturing process or improving staff training.
- Change Control: Change control is the process of controlling and documenting any changes made to facilities, product or process. This process helps ensure that changes are made in a controlled manner, and potential risks are identified and managed appropriately. For example, if a pharmaceutical company decides to change the supplier of any raw material, they will need to evaluate the impact of the change on the product and update the necessary documentation, such as the batch record and SOPs.
- Complaints Handling: Complaints handling involves managing customer complaints and ensuring that they are resolved in a timely and effective manner. The process includes receiving, documenting, investigating, and resolving complaints and implementing corrective actions to prevent a recurrence. For example, you could receive a complaint regarding a physical defect in a tablet, a change in color, or a defect in packaging. The complaint would be documented, and an investigation would be carried out to identify the root cause of the adverse effects. Corrective actions would then be taken to prevent a recurrence.
- Out of Specification (OOS): Out of Specification (OOS) refers to results that fall outside the predetermined specifications. OOS results can be caused by analytical instrument malfunction, human error, or product variability. The process of managing OOS results involves documenting and investigating the cause, implementing corrective action to address the issue, and evaluating the impact on the product. For example, if a batch of a drug fails a dissolution test, the manufacturer would investigate the cause, such as instrument malfunction or operator error, and take corrective action.
- Supplier Qualifications and Audits: Supplier qualifications and audits involve documenting the process of qualifying suppliers to ensure that they meet quality requirements and keep a reference of all data collected during the process for visibility to the operation and audits. The process includes identifying suppliers, conducting audits, and maintaining records of required GMP related documents like Drug Master file (DMS) and certificates. For example, a pharmaceutical company would evaluate the compliance of a potential supplier of raw materials, conduct a supplier audit to evaluate their quality systems, and maintain records of the supplier’s quality performance.
- Document and Training Management: Document and training management involve managing documents related to product quality, such as SOPs, batch records, and validation protocols. The process includes ensuring that documents are up to date, managing document revisions, and maintaining related records of staff training.
Note: Watch our QMS webinar ondemand to learn more about these seven capabilities.
Implement Quality Management Features in Stages
While all the features in a QMS are important, it’s often a challenge to try and implement everything at once. The better approach is to implement features in stages. Which features to implement first depends on the specific needs and challenges of each organization, but there are some general guidelines we recommend to companies to get started.
The first operations system we see small pharma companies put in place is electronic document management because it’s the easiest to implement and show value. However, either at the same time or immediately after, we recommend implementing basic quality management features such as Deviations, CAPA, and Change Control.
For example, if an organization is experiencing recurring quality problems pertaining to deviations from SOPs and processes, starting with a robust deviation and CAPA process would be a good place to begin.
Once the basic capabilities are in place and everyone is trained to use them, you can start working with features such as change controls, audits, complaints, OOS, and supplier qualifications. For example, if supplier-related quality issues are a concern, supplier qualifications and audits could be prioritized.
A final capability is the ability to scale to other manufacturing (EBR), calibration, maintenance and lab (LIMS) in the same platform. This means that you can integrate and streamline your workflows across different departments and functions, without having to switch between multiple systems or applications. You can also leverage the data and insights from each module to optimize your performance and quality. By using a single platform for all your manufacturing and lab needs, you can reduce costs, increase efficiency and ensure compliance.
Implementing the entire QMS system’s modules at once would give you a leap into your Quality management maturity and digital transformation. However, breaking down your QMS journey according to your company’s major pain points, goals and priorities is a great starting point to drive change. If you’re still not sure how to proceed with your quality management system implementation, please reach out for a conversation.