uality is one of the most important management principles for any organization regardless of industry. This is particularly true for the pharmaceutical sector: maintaining quality product standards is essential for the prevention and treatment of numerous medical disorders.
Although the pharmaceutical industry has been around for centuries, in recent years we have experienced an increase in the number of drugs being launched in the market. As a result of this increase, the need for quality assurance and quality control measures has risen. For instance, drug manufacturers must follow strict guidelines to get their drugs approved by the FDA (Food and Drug Administration) in the United States. Such guidelines include requirements for testing, manufacturing, labelling, packaging, storing and distributing pharmaceuticals.
Quality Management
Quality management is a crucial component of any successful organization as it ensures that products and services are produced and distributed consistently and effectively.
Good Manufacturing Practice (GMP) is the element of quality management that ensures goods are produced and controlled according to the quality standards of their intended use and that they meet the requirements specified by the marketing authorization or product specification. Additionally, it ensures that manufactured goods are safe, of high quality, and effective. For pharmaceutical companies, GMP entails the monitoring of procedures, apparatuses, employees, and environments.
Quality planning, quality control, and quality assurance are all important aspects of quality management too. We’ll look at what quality management is, why it’s important, and the main components and principles of quality management in this article.
Quality planning
Quality planning refers to the process of defining the quality requirements and standards of a product or service and identifying the resources needed to meet such requirements and standards. The planning phase is the first stage in establishing a good quality management system. It is in this phase that companies define their baseline quality objectives. Once goals have been set, organizations must determine what is required to achieve these objectives and what procedures should be implemented to ensure their success. During this stage of the quality management process, it is important to keep in mind the following considerations:
The organization’s definition of success
How often procedures and processes will be evaluated for improvement
If the stakeholders have any quality-related priorities, goals, or ambitions
If there are any legal procedures or standards that must be followed in order to achieve the desired quality level
Quality Control
Quality control is the next step in the quality management process. At this stage, companies assess through physical inspection and testing whether their plan is achievable.