Quality Standard

Overview Of Key Concepts :

Quality is all about customer satisfaction. Quality is important because it affect a customer’s perception of the business- therefore it can affect present and future sale of products. There are several ways businesses can ensure quality is achieved either through quality control system or quality assurance.

Quality:

Definition: is a measure of excellence which is free from defects or significant variations. A product or service whose features allow it to satisfy (or delight) customers. Quality is a matter of personal opinion-so it is subjective from one customer to another.

Quality Standards:

This is a set of criteria used to establish quality system which are accredited pharmacopeias and international standards.
Achieving these standard means the business can gain more advantages.

The quality standards are follows:

1. Customer Focus:

Simpex pharma worked on customer-focused culture and offer a host of benefits, including greater brand valuation, customer loyalty, and increased market share. We make sure that quality management is done with the customer in mind.

2. Total Employee Involvement:

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 2015 academic study independently examined the eight components of an ISO 9001 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
• Training, communication, empowerment, rewards, and recognition are effective means to engage the workforce to positively impact quality results.

3. Process-Centered Approach:

This process-based method is a core principle of the pharmaceutical QMS approach that ISO prefers, supporting continuous improvement, predictable results, and efficient performance.

We having clear SOPs for every task and responsibility in the organization requires pharma organizations to shift their focus to the entire product lifecycle. We follow the vedor qualification proceed instead of relying on the vendor for quality on partnerships in the supply chain. If the test results for a raw material good, we move further for approval of vendors.

We follow the process-centered quality management systems and that is crucial for regulatory compliance in pharma, particularly at organizations that rely on entirely outsourced manufacturing partnerships. Pharmaceutical quality management software provide transparency throughout the product lifecycle and clear guidance for supply chain partners to adopt a risk-based approach to quality management. We Simpex pharma consider 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:

We Simpex pharma 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 SAP software that complies with cGMP and ICQ10 support the transparency of information. Based on ISO guidance and cGMP, 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

5. Strategic and Systematic Approach:

At Simpex pharma a 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. The leadership team is tasked with creating a culture of quality and inspiring excellent performance.

A strategic approach to 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 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 Simpex pharma, 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 consistentopportunities.

Simpex pharma focus on efforts to improve on developing greater internal efficiencies, meeting current and emerging customer requirements, and adapting to meet changing market conditions. A 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 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