What is a Pharmaceutical Quality Management System and Its Benefits?
July 25, 2024
For the pharmaceutical industry, maintaining rigorous standards of quality is not only a legal obligation but also a public one. That is no simple feat. Ensuring that every pharmaceutical that reaches the market is consistently safe and effective requires a rigorous quality management plan. That’s why regulatory bodies around the world require pharmaceutical companies to establish a quality management system (QMS).
Today’s successful pharma companies address their QMS needs using pharmaceutical QMS software. This article explores pharmaceutical QMS systems, outlining critical components, the benefits of implementing a pharma QMS, and how to efficiently address the essential regulatory and compliance standards that govern the industry.
What is a pharmaceutical quality management system?
A pharmaceutical quality management system is a comprehensive framework that encompasses all of the processes, procedures and tasks necessary for achieving and maintaining product quality and regulatory compliance. QMS tasks run the quality control and assurance gamut, from risk management to equipment calibration to continuous improvement.
Pharmaceutical Regulatory and Compliance Standards
Pharma manufacturers are faced with numerous regulatory standards, from the most basic, such as General Manufacturing Practice (GMP) to the more specific, such as ISO 15378, which focuses on pharmaceutical packaging materials. Below is an overview of the most-used pharmaceutical quality standards and regulatory guidelines.
FDA 21 CFR Part 211 is the primary standard outlining the steps for meeting minimum current good manufacturing practice (cGMP) standards for finished pharmaceuticals in the United States. Being able to meet its standards is required for U.S. Food and Drug Administration (FDA) approval, with the goal of assuring that “the drug products have the identity, strength, quality, and purity they purport.”
FDA 21 CFR Part 210 is used in conjunction with Part 211. Where Part 211 focuses on process control for finished pharmaceuticals, Part 210 puts forth minimum standards for manufacturing, facilities and controls.
Meeting these FDA standards is a complex endeavor, but the major elements involve:
- Qualifications and skills of personnel
- Equipment and facilities maintenance
- Control of components, product containers and closures
- Production and process controls
- Packaging and labeling controls
- Warehousing and distribution
- Laboratory controls
- Records and reports
Evolving regulatory guidance for the pharmaceutical industry emphasizes risk management and quality control, calling on pharma to keep the end user in mind at every stage of the process, from development to market distribution. Pharmaceutical manufacturers need to provide transparency and traceability at every step and for every input.
ISO 9001:2015 ISO 9001 is an international quality management standard that promotes the process approach, which is based on the premise that consistent and predictable results are best achieved when individual tasks are managed as a function of a total, coherent system. To address this standard, QMS software should be able to automatically manage each step in the process, including planning, implementing and assessing quality processes.
ISO 17025 ISO 17025 is an international standard that targets laboratories and their ability to demonstrate that they operate competently and generate valid results. Quality efforts, such as providing a framework for safety and testing, are critical to pharmaceutical quality management.
GMP Good manufacturing practices (cGMP in the United States) is another global set of standards that promotes risk-based quality management methods based on real-time data insights. Quality management systems should help pharma companies identify, assess and mitigate potential risks that may affect the product and ultimately users.
European Medicines Agency guidelines for the quality of pharmaceuticals in EU member states are provided for all stages of a pharmaceutical’s life cycle, with ICH Q8, Q9 and Q10 acting as the main drivers for development, manufacturing and risk management.
The guidelines were developed by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which was established in 1990 by regulatory and industry bodies from Europe, the United States and Japan in an effort to streamline pharmaceutical regulations in an increasingly global market.
ICH Q10 provides a model for an effective pharmaceutical quality management system. ICH Q10 is being looked to more and more by those creating pharmaceutical quality processes as it provides in one model what is addressed in both ISO and GMP quality guidelines and standards.
Also in the European Union, EU Annex 11, a supplement to EU GMP that outlines the requirements for all computerized systems used to manufacture human and veterinary medicines. It seeks to help organizations mitigate risk by offering guidance on using electronic signatures, maintaining data integrity and security, traceability and training. It requires all computerized systems to be validated and the IT infrastructure to support operations.
Pharmaceutical QMS software
QMS software helps simplify all aspects of the quality management process by automating workflows to ensure all procedures are followed, managing documentation and approvals, ensuring suppliers adopt quality and risk management processes, utilizing real time data and providing built-in transparency and traceability.
Pharma companies that implement QMS software can gain considerable efficiencies by automating key quality tasks, including:
Document Management – QMS software ensures all documents are accessible from one, centralized location and provides version control and automatic archiving. Electronic review and approval with built-in reminders and the ability to capture electronic signatures helps to keep document approvals on track and affords built-in traceability for regulatory purposes.
Risk Management – QMS software allows you to harness your data to identify and monitor potential risks, automating risk-management tasks. With it users can create risk assessments from other quality functions, such as customer feedback, then evaluate and report on risk assessments using real-time data and a paperless environment that streamlines the process from beginning to end.
Training Management – Managing employee training is simplified through integration with quality tasks, including connecting training to document changes. Employee training QMS applications allow managers to access real-time information on the status of employee training and to easily pull employee-training data for progress or audit reports.
Change Control – Automating change control processes streamlines change tasks, ensuring they are appropriately monitored and documented. Integrations with other quality processes, such as corrective actions, deviations and document management enhances efficiency and accuracy.
CAPA Management – QMS software provides tools to manage all of your CAPA processes, from root cause analysis to approvals and verification of effectiveness. CAPA activities can be initiated via other QMS software applications, such as customer feedback and inspections, and supplier CAPA activities integrated as well.
Supplier Management – QMS software streamlines supplier relationships, automating workflows, documentation and communication. Supplier QMS applications can track and trace supplier interactions, helping you to stay on top of work and giving you real-time supplier data for use during audits and planning.
Electronic Batch Records (EBR) – Electronic batch record software tracks, monitors and reports on batch production in real time, guaranteeing that ingredients, procedures and sequences are used as required, and providing full, automatic traceability.
Audit Management – Audit management applications automate the process of preparing and executing audits by helping companies analyze data, assess risks, track issues, report results and centralize documentation. Regulatory compliance is streamlined and simplified with centralized workflows and full traceability.
Deviation Management – Easily capture deviation data, monitor progress and ensure resolution of deviations through a systematic process supported at all points by QMS software. Integrations with customer feedback, supplier management, corrective actions and more, enable efficiency and ensure the most accurate data is used.
Benefits of QMS Software for Pharma Companies
Regulatory Compliance - By automating your QMS, pharmaceutical companies ensure that they are adhering to regulatory standards, reducing the risk of penalties and product recalls.
Enhanced Product Quality - QMS software establishes robust quality control processes, reducing the likelihood of product defects and contamination, instilling a sense of confidence in the product as well as the company.
Patient Safety - eQMS software helps pharmaceutical companies implement stringent quality control measures and safety protocols to mitigate potential risks to patient safety and build trust among consumers.
Risk Mitigation and Management - QMS software helps companies proactively identify, assess and mitigate risk, such as supply chain disruptions, safeguarding operations and patient well-being.
Continuous Improvement - QMS software fosters a culture of continuous improvement that enables pharma companies to enhance overall performance, meet market demands and drive innovation through a structured monitoring and feedback loop.
A well-executed pharmaceutical QMS is indispensable for meeting regulatory requirements and safeguarding consumer health. By adopting comprehensive QMS software, pharmaceutical companies can efficiently manage compliance, enhance product quality and ensure patient safety. As the pharmaceutical industry moves forward, embracing these technologies will be essential for sustaining high quality standards and fostering innovation in pharmaceutical development and production.
