What Are The Essential Elements of Pharmaceutical Quality ...

If you aren’t following current good manufacturing practices (cGMP), ISO standards or ICH Q10 guidance, you’re leaving yourself open to making errors and incurring penalties from the Food and Drug Administration (FDA).

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Per the FDA ICH Q10 guidance, standards for quality management in pharma include:

• Building quality into processes upfront instead of improving with additional testing/inspection
• Using rigorous, modern science throughout the product lifecycle
• Enabling effective decision-making with quantitative risk management
• Employing quality management software to protect knowledge management and transfer
• Adopting an integrated approach to development, manufacturing, and quality

For quality assurance, continuous improvement, and overall customer satisfaction, you need a quality management system (QMS). An effective pharmaceutical quality management system promotes a customer-focused culture, encourages employee involvement, and incorporates other QMS principles for highly regulated industries. Here are eight things you should include when building your quality management system.

1. Customer focus

Organizations succeed when they build trust and create customer value with every interaction. ISO says “striv[ing] to exceed customer expectations” should be the primary focus of a quality management system. A customer-focused culture can offer a host of benefits, including greater brand valuation, customer loyalty, and increased market share. Make sure that your quality management is done with the customer in mind.

Brand valuation

The genuine desire to help patients should be integral to pharmaceutical QMS. An effective pharmaceutical quality system should encourage pharmaceutical companies to improve the quality of their products and the speed of delivery.

While many industry execs understand the value of creating a customer-obsessed culture, emulating the efforts of customer-centric brands like Apple has been harder to achieve. Some of the factors behind the pharma industry’s struggle to focus on the customer are very pragmatic—it’s near impossible to pivot products or achieve true organizational agility in product development in such a highly regulated industry.

Startups and scale-ups in the pharmaceutical industry often have an advantage in establishing a customer-centric culture. Many firms in the R&D phase of the product lifecycle, such as EUSA Pharma, were founded around a passion for helping patients and haven’t yet lost sight of the customer journey. EUSA, a UK-based company that operates globally, has a simple mission: to “change lives, patient by patient.”

Customer loyalty

Pharmaceutical companies are facing extraordinary pressure to adapt to changing market conditions, including the shifting role of the patient in healthcare. Technologies such as medical devices and SaMD are enabling pharmaceutical customers to engage deeply with their healthcare providers, personal health data, and treatment plans. Simultaneously, advancements in the life sciences field have created an increasing number of possibilities for patients to receive personalized care.

Innovative pharmaceutical organizations that adopt a customer focus can gain an enormous advantage with new approaches to research and development. Using big data on patient populations can reveal emerging opportunities to strengthen patient engagement. A McKinsey article cited that a pharmaceutical company that launched a digital companion app for rheumatoid arthritis patients saw drug sales increase 8%. By focusing on your customers during the quality management process and beyond, you’re able to work on building up their loyalty to you.

Increased market share

Establishing a strong focus on the customer has clear benefits for quality-driven organizations in any industry, especially in verticals such as pharma, where customer expectations are changing rapidly. The long-term sales performance of a drug is closely tied to market performance during the first six months after its release, according to McKinsey research. Providing a differentiated, personalized customer experience can be a determining factor in whether a newly released drug captures market share.

2. Total employee involvement

Quality isn't a checklist, a goal of the management team, or the responsibility of the quality unit—it's a core component of a culture that should be owned by every member of the organization. Every employee at a pharma organization has an impact on the company's ability to deliver a quality product, from research scientists to janitorial staff.

W. Edward Deming, a pioneer of quality management practices in Japanese manufacturing, proposed in his book that employees are ultimately responsible for quality, arguing that there is a clear link between employee involvement and quality management practices in the pharma industry and that every employee must view it as a personal goal to improve quality.

To involve employees in improvement, a pharma QMS should create an empowered and knowledgeable workforce through practical training, collaboration tools, and clear channels for communicating opportunities. A academic study independently examined the eight components of an ISO QMS to determine which principle had the most significant impact on quality. Those components included:

• Customer focus
• Leadership
• Employee involvement
• Process approach
• Systemic management
• Continual improvement
• Evidence-based decision making
• Mutually beneficial supplier relationships

The researchers performed interviews and statistical analysis of 40 large European pharmaceutical companies and discovered employee involvement is the single most important factor in the success of all other QMS principles. Training, communication, empowerment, rewards, and recognition are effective means to engage the workforce to positively impact quality results.

3. Process-centered approach

When your company's workflow is treated as an interrelated process rather than individual, unrelated tasks, you'll start to see consistent and predictable results. This process-based method is a core principle of the pharmaceutical QMS approach that ISO prefers, supporting continuous improvement, predictable results, and efficient performance.

Developing clear SOPs for every task and responsibility in the organization requires pharma organizations to shift their focus to the entire product lifecycle. Historically, pharma manufacturers could place responsibility for quality on partnerships in the supply chain. If the test results for a raw material were good, your company could move on. Recent updates to cGMP have shifted the regulatory burden onto pharma companies to guarantee quality standards throughout the product lifecycle.

Process-centered quality management systems are crucial for regulatory compliance in pharma, particularly at organizations that rely on entirely outsourced manufacturing partnerships. Pharmaceutical quality management software should provide transparency throughout the product lifecycle and clear guidance for supply chain partners to adopt a risk-based approach to quality management. Pharma organizations should consider whether a QMS supports process-centered best practices, including:

• Conducting supplier risk assessments
• Performing supplier audits
• Monitoring, documenting, and reviewing supplier performance
• Establishing written quality guidelines and SOPs for suppliers

4. Integrated systems

An organization can only optimize products and performance by understanding how a system produces results. Quality management systems consist of a framework for the governance of interrelated processes. Transparency throughout the product lifecycle is necessary.

A comprehensive QMS software that complies with cGMP and ICQ10 can support the transparency of information. Recent research published in the International Journal for Quality Research defines the critical elements of an integrated QMS for pharma. Based on ISO guidance and cGMP, researchers determined that an integrated pharma system must support:

• Quality policy
• Personnel
• Development and implementation
• Production
• Documents
• Facilities and equipment
• Self-inspection
• Management responsibilities
• Evaluation of suppliers and purchasing
• Supplier production and analysis
• Risk analysis
• Monitoring and control
• Complaints and recalls
• Corrective and preventive actions (CAPA)
• Measurement, analysis, and improvement

In addition to a QMS that is integrated with processes for manufacturing, clinical research, and development, the software should support ease of use and scale as a pharma company grows without requiring resource-intensive revalidation.

5. Strategic and systematic approach

Leadership is integral to a strategic and systemic approach to quality-driven organizations. The management team is responsible for refining the organization's vision, circulating this purpose, and encouraging employees to engage with quality goals. In a pharma company, the leadership team is tasked with creating a culture of quality and inspiring excellent performance.

A strategic approach to pharma leadership allows a company to become more forward-thinking. Instead of focusing on immediate objectives, management review efforts are driven by a clear roadmap for clinical development. Decisions are made based on accurate documentation for risk management and clear quality objectives.

A QMS plays a core role in helping pharma companies take a systemic approach to achieving both short-term and long-term quality objectives, providing transparency, offering ease of access to information, and improving communication. A QMS can support strategic leadership with:

• Coordination of processes across the organization
• Support for real-time collaboration and communication
• Training and education to help every member of the organization improve quality

6. Continuous improvement

Continuous improvement is critical to the success of organizations in any industry. For pharma companies, constant improvement is imperative to survival. The pharmaceutical industry is under intense pressure to meet strict regulatory requirements and pricing pressures while evolving to meet changing customer expectations. A formalized approach to improvement can allow organizations to meet standards while capturing consistent opportunities.

Efforts to improve in pharma should focus on developing greater internal efficiencies, meeting current and emerging customer requirements, and adapting to meet changing market conditions. A QMS software can enable leadership to create improvement objectives and discover opportunities based on real-time data sources, such as customer satisfaction, complaints, market research, audits, records, employee feedback, and other data sources.

A pharmaceutical QMS can enable continuous improvement by:

• Providing a centralized system for creating improvement objectives
• Elevating employee education on SOPs, best practices, and improvement goals
• Assessing employee training performance to ensure competency
• Encouraging employee collaboration on improvement efforts
• Tracking and auditing progress toward meeting quality standards

7. Fact-based decision-making

Making data-driven decisions means you’re more likely to get the results you want. Evidence-based decision-making is among the core principles of ISO. Driving quality improvements and effectively addressing nonconformance requires organizations to use data and analytics to determine root cause relationships and potential consequences.

Data-driven decision-making isn’t a new concept for pharmaceutical companies. The industry has long embraced periodic measurement and management reviews of quality.

What's new, however, is the clear focus in ICH Q10 for companies to shift to risk-based management methods based on real-time data insights. Pharmaceutical executives are now required to make decisions based on data throughout the product lifecycle. A QMS must provide comprehensive picture and analysis capabilities to avoid the risks of N=1 assumptions. Data can help leadership decide where change makes sense and when immediate changes are necessary to protect product quality.

Change is costly, but the quality risks from an incomplete analysis can be even more expensive for pharmaceutical organizations. A QMS system should provide a full scope of data from a variety of sources to help the quality unit and leadership identify the root cause among SOP changes, manufacturing shifts, or other factors. Pharma quality management systems should provide transparency into both drivers and outcomes to measure impact.

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8. Communications

Effective relationships and communication are crucial to getting your employees, processes, and technology aligned properly. Systems for communication should support real-time, productive dialog between leadership, quality, employees, and third-party organizations in the supply chain. Recent shifts in regulatory responsibility have made it more critical than ever for pharmaceutical organizations to communicate effectively with members of the workforce and suppliers located around the globe.

To support relationships in a quality-driven organization, ISO advises companies to "pool and share information, expertise and resources with relevant interested parties," provide success metrics and channels for feedback, and refine methods for collaboration. While a QMS software for collaboration and document management isn't strictly necessary, a cloud-based system can significantly improve the success of communication initiatives.

A QMS system should support regular communications with global stakeholders around product quality and status. Communications should be easy to track and distribute based on roles. A QMS should offer ease-of-use for end-users with simple search features and mobile access for real-time collaboration.

Get a QMS that provides the essential elements for your pharma company