Quality in the pharmaceutical industry is defined, in part, as products which are safe for intended use, effective, and meet patient expectations. Consistently delivering quality is more complicated than consistent testing procedures, according to regulatory guidance. Current good manufacturing practices (cGMP) dictate that quality control and assurance must be incorporated into all processes, from research and development to production.
In recent years, the FDA has issued a mounting number of warnings for failure to comply with cGMP for quality, including warnings for failed documentation, ineffective standard operating procedures (SOPs), or inadequate CAPA handling. A pharmaceutical quality management system (QMS) software can prevent regulatory risks by providing a unified framework for quality across the product lifecycle.
While cGMP are focused primarily on quality control and assurance, FDA Industry Guidance for a Q10 Pharmaceutical Quality System describes one model for QMS based on cGMP and ISO. Understanding this guidance can help your organization adopt a QMS which reduces your regulatory risks. In this post, you'll learn how the right QMS can simplify compliance in the pharmaceutical industry, and how to select software with safeguards against common failures.
QMS in Pharma: How Software Can Ensure You Meet Compliance Guidelines
A Quality Management System (QMS) software can provide a comprehensive framework for pharmaceutical organizations to comply with cGMP for quality control and assurance across the product lifecycle. QMS can safeguard against regulatory risk by assuring accurate record-keeping and processes to comply with operating requirements such as SOPs, audits, testing, and manufacture.
According to FDA IQ10 guidance, a QMS should "encourage the use of science- and risk-based approaches at each lifecycle stage, thereby promoting continual improvement." The QMS should reduce quality and compliance risks for operations "not explicitly address[ed]" by regional GMPs. Per the FDA, an effective pharmaceutical quality system helps an organization:
- Achieve product realization
- Establish and maintain a state of control
- Facilitate continuous improvement
The QMS should provide safeguards to help the organization maintain a quality-driven culture and operationalize compliance with cGMPs. At organizations of any size, pharma QMS software should provide adequate safeguards for standardized operations, visibility, and offer the capability to expand.
Safeguard #1: SOP Distribution at the Point of Use
An SOP is defined by the FDA rather simply, as a written procedure which details how to correctly and safely perform essential job duties. An effective SOP should ensure employees consistently fulfill their responsibilities in a way which upholds product quality.
Despite this simple definition, effectively complying with requirements for SOPs can be deceptively complex. Even at small organizations such as pharma startups, there may be a need for hundreds of SOP documents to detail each task, which include:
- 21 CFR 211.25 Provide “education, training, [and] experience” to each person engaged in the product lifecycle.
- 21 CFR 211.22(d): Define the responsibilities and procedures for the quality unit.
- 21 CFR 211.100: Written procedures for production and process control to assure “identity, strength, quality, and purity.”
cGMP dictate the importance of creating, maintaining, and distributing SOPs, as well as documenting employee understanding and taking corrective action. Failure to adequately maintain and distribute SOPs is a common reason for FDA Form 483 warning letters.
A QMS software should provide a safeguard against regulatory risks related to SOPs by providing a comprehensive platform for document management, distribution, and training. Paper-based methods of SOPs can present significant risks to compliance since each process change requires SOP updates, approval, and redistribution to staff.
QMS can introduce efficiency by offering streamlined workflows for SOP updates, approval, and training. Cloud-based software for pharma can encourage a quality-driven culture by making documents accessible to the right employees at the right time. SOPs should be available at the point of access in formats that are convenient to the workforce, such as mobile devices or tablets.
Safeguard #2: Transparent Compliance
A "loss of management control" is sometimes cited in warning letters from the FDA. This can occur when organizations experience missed deadlines, product deviations, or other failures attributable to weak oversight. Without a comprehensive solution to continually understand compliance with cGMP, the quality unit and leadership team can struggle to recognize risks.
According to FDA IQ10 guidance, a pharmaceutical quality system (PQS) should ensure compliance with:
- Documentation Architecture
- SOP Implementation
- Tools for Quality Control
- Accurate Records-Keeping
- Clear Visibility
To avoid visibility failures, consider how a prospective QMS can increase transparency of compliance for leadership, quality, and the workforce. Systems with a clunky user experience may not simplify compliance. Using software designed for QMS in less highly regulated industries could require extensive customization and revalidation. Features such as closed-loop reporting, process automation, and automated notifications can improve transparency for pharma companies.
Related Reading: The Key to Future-Proofing Pharma Compliance
Safeguard #3: Easy Expansion
Pharmaceutical companies are under intense pressure to comply with evolving regulatory guidance, bring products to market, control costs, and maintain quality documentation. Maintaining agile operations sometimes requires companies to pivot quickly without sacrificing quality or compliance.
In some cases, a QMS can even introduce regulatory risk by:
- Lacking change identification features for electronic records
- Confusing document search and architecture
- Ineffective linking between related documents
- Poor capabilities for collaboration and approval
- Not supporting document templates
Change is a constant in the pharma industry, and organizations need systems which can seamlessly scale to meet evolving requirements. A QMS should simplify compliant expansion by making it easy for employees to create new documents, update documentation, and add features on an as-needed basis without having to seek revalidation. You could face regulatory risk with a QMS which inadvertently encourages employees to work outside the system by offering a clunky user experience.
Scalability in a QMS for Pharmaceutical Companies
QMS software can be an essential tool for creating a culture of quality in organizations across industries, from manufacturing to medical devices. Pharma companies should consider the value of a QMS designed specifically under FDA and ISO guidance to meet cGMP. A purpose-built solution which aligns with FDA ICQ10 industry guidance can safeguard against regulatory risk.
In addition to an industry-specific solution, pharma companies should consider how company size, stage, and growth goals impact QMS needs. Pharma startups and scale-ups may have very different software requirements than an enterprise with an extensive market portfolio. For instance, Qualio is the first QMS explicitly designed under FDA guidance for pharma companies with 5-250 employees. Identifying the best QMS software for your company can simplify compliance and quality-driven operations.