Quality Culture in Pharmaceuticals

The quality of pharmaceuticals is a major concern in the pharmaceutical industry. The quality of the product indicates the seriousness of the manufacturer towards the safety of patients. It means that defects in the quality of the product may harm the user of the product.

Low-quality products are not accepted in the regulatory market and should not be accepted anywhere because it can harm the user. The best way to achieve the best product quality is to develop a culture of quality in the manufacturing facility. Every employee must be aware of quality and quality must be in the blood of every employee in the organization, from a worker to top management.

First, a gap analysis is required to determine the current condition of the company with respect to quality. Some questions could be asked, such as: What is the current state of the quality culture in the QC lab, production floor, warehouse, and other departments, including offices? What does the company want to achieve? A set of objectives can help build a solid company foundation for a culture of quality.

After getting the answer to these basic questions, you should take a look at the plant employees to learn the requirements for quality improvements. A discussion should also take place in top management and decision makers on improving the quality culture in the workplaces.

To develop a culture of quality among employees, top management must show its commitment to quality to its subordinates. This will send a message to all employees to be strict about product quality. The participation of managers in plant work can help to obtain better results. A schedule should be made to visit the production floor and talk to employees about quality improvement. After a short period, employees begin to see that management is serious about quality.

Employee engagement also helps build a culture of quality. Employees cannot be appreciated just for their promotion or bonus but also feel appreciated when their opinion is taken for any improvement. They feel belonging and attachment to the company and this will commit them to building a culture of quality.

In general, employees in all departments try to find the work shortcuts that spoil the quality. People must be trained for the same to achieve the quality objectives of the company. From my personal experience in the pharmaceutical field, the main cause of the shortcut is the workload. Most pharmaceutical companies have labor shortages and this puts additional workload on employees. Top management must provide enough staff to all departments to run smoothly.

A change in processes and methods occurs regularly in pharmaceuticals. Employees are required to be trained for regular cGMP updates. Changes to guidelines, documentation, and SOPs must be properly conveyed to the end user. A knowledgeable employee will never deviate from any process and will always work like a trusted soldier.

A successful quality culture cannot be built in a day, but it takes time with a commitment to quality from top management down to the floor employee. After a short period, everyone gets the benefit of quality commitment when a quality culture is built in the company.

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