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Quality Management

Business Plan for QMS Implementation in Low- and Middle-Income Countries: Driving Success through Flexibility and Cost-Effectiveness [Sample Business Plan included]

A quality management system is essential for any organization that wants to achieve sustainable growth, retain customers, and gain a competitive edge in the market. However, when it comes to quality management systems, a well-drafted and comprehensive business plan becomes even more critical. It lays the foundation for establishing an effective quality management system that […]

Managing Quality Assurance and Manufacturing with Daily Standup Meetings – A Case Study [Template Included]

In today’s fiercely competitive business world, quality assurance and manufacturing are the two critical pillars upon which the success of any organization rests. With the growing complexity of manufacturing, there is a need for a streamlined approach to quality assurance and manufacturing management. Daily standup meetings offer an increasingly popular and effective way to manage […]

Setting Risk Targets for Inspection of Pharmaceutical Companies in Low and Middle Income Countries: A Four Step Approach

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Pharmaceutical companies are indispensable in providing essential medicines to the global population. However, in low and middle-income countries, the regulation of these companies is often insufficient, leading to risks of substandard, falsified, or counterfeit medicines. To ensure compliance and the delivery of safe and effective medicines, inspection of pharmaceutical companies is essential. The challenge, however, […]

Internal Auditor Questionnaire: Ensuring Compliance and Best Practices

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In the pharmaceutical industry, maintaining compliance and adhering to best practices is critical to ensuring the safety and efficacy of drugs and medical devices. With the ever-changing regulatory landscape, it can be challenging for companies to keep up with the latest requirements and standards. In order to meet these requirements, companies must establish internal audit […]

Quality Management System (QMS) vs Pharmaceutical Quality System (PQS): a Head-to-Head Comparison & Key Considerations

Quality Management System (QMS) refers to a set of interrelated or interacting elements that guide an organization in achieving quality objectives and continuously improving its processes, products, and services. On the other hand, PQS focuses specifically on pharmaceutical products’ safety, efficacy, and quality throughout their life cycle, including research and development, manufacturing, distribution, and post-market […]

From Process to Product: How ICH Q10 PQS Features Ensure Quality in the Pharma Industry

The ICH Q10 Pharmaceutical Quality System (PQS) is an essential quality management system utilized in the pharmaceutical industry, which aims to ensure the highest quality in regards to the development and manufacture of pharmaceutical products. Quality is an essential aspect of the pharmaceutical industry, and the ICH Q10 provides a comprehensive and systemic approach to […]