Good Manufacturing Practice (GMP) audit is an essential process for ensuring that products are consistently meeting the established quality standards. Regulatory authorities also require industry to apply quality risk management principles during the audit. This helps in minimizing risks involved in pharmaceutical production that cannot be eliminated through testing the final product. Below, we will […]
Ensuring regulatory compliance in pharmaceutical manufacturing is critical for maintaining product quality, safety, and efficacy. The following key areas highlight essential practices and regulations that pharmaceutical companies must adhere to: GMP (Good Manufacturing Practices) Compliance Strict adherence to GMP (Good Manufacturing Practices) regulations is crucial for quality assurance in pharmaceutical manufacturing. GMP standards ensure that […]
Importance of Quality Control – as the First Line of Defense The article discusses the main responsibilities, required skills, and the importance of the first line of defense for quality control (manufacturing and service industry). It also gives suggestions for improvement. Interested in the “How to Guide” for this article? Subscribe and we will notify […]
Drug regulatory authorities (DRAs) in low- and middle-income countries (LMICs) must focus on a set of core functions to ensure safe, effective, and high-quality medicines are available to their populations. Minimum (essential) Regulatory functions Regulatory authorities in LMICs may face specific challenges such as limited resources, lack of infrastructure, and insufficient technical expertise. Strategies to […]
In Low- and Middle-Income Countries (LMICs), ensuring the quality, safety, and efficacy of pharmaceutical products is crucial to protect public health. One important aspect of maintaining high-quality standards is to reduce regulatory burden through self-inspection programs conducted by pharmaceutical manufacturers. These programs aim to identify and address any potential risks or vulnerabilities within their manufacturing […]
Pharmaceutical facilities are subject to strict regulations and requirements, as they deal with the production and distribution of medicine. To ensure that they are meeting these standards, it is essential to conduct regular internal audits. These audits are meant to evaluate and assess the facility’s compliance with regulations, identify areas of improvement, and implement corrective […]
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 […]
GMP is a set of guidelines that helps ensure that pharmaceutical products are consistently produced and controlled according to quality standards. In this blog post, we’ll be diving into the essential guide to GMP for pharmaceutical professionals, covering its 20 key principles. From manufacturing to quality control, we’ll explore each principle in an easy-to-understand manner. […]
When it comes to essential medicine manufacture in Low- and Middle-Income Countries (LMICs), there are significant gaps that need to be addressed. Capacity building is essential to bridge this gap, and McKinsey’s 7Ss Framework provides the perfect approach to analyze and improve the situation. In this blog post, we’ll dive into the McKinsey 7Ss Framework […]
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 […]
