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Build a Quality Culture in Pharmaceuticals

Product quality is the thought of past, today is the age of quality culture. None can win the race of quality without a quality culture in the firm.
Quality of pharmaceutical products is a major concern in the pharmaceutical industry. Quality of product indicates the seriousness of the manufacturer towards the safety of the patients. It means defects in product quality may harm the user of the product.

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

Quality Culture in Pharmaceuticals
First of all, a gap analysis is required to determine the current condition of the company with regard to quality. Some question could be asked, such as: What is the current status of quality culture in quality control laboratory, shop floor, warehouse and other departments including offices? What does the firm want to achieve? A set of goals can help to build a strong base of the firm for quality culture.

After getting the answer to these basic questions a view of shop floor employees should be taken to know the requirements of the improvements in quality. A discussion should also be conducted in upper management and decision makers on the improvement of quality culture on workplaces.

To develop a quality culture among employees top management must show their commitment to quality to their subordinates. This will convey a message to all employees to be strict on the quality of the product. The involvement of the managers on shop floor working may help to get better results. A schedule should be made to visit the shop floor and talk to the employees about the improvement of quality. After a short period employees start to see that management is serious about the quality.

Engagement of the employees also helps to build quality culture. Employees cannot be appreciated only by their promotion or bonus but they also feel appreciated when their opinion is taken for any improvement. They feel ownership and attachment with the firm and this will commit them to build a quality culture.

Generally, employees in every department try to find the shortcuts of working that spoils the quality. People must be trained for the same to achieve the quality goals of the company. On the basis of my personal experience in the pharmaceutical field, the main cause of shortcut is workload. Most of the pharmaceutical companies have manpower shortage and this generates the extra workload on the employees. Senior management should provide sufficient staff to all departments for smooth working.

A change in processes and methods occurs regularly in pharmaceuticals. Employees are required to be trained for regular cGMP updates. Changes in guidelines, documentation and SOPs should be properly conveyed to the end user. A well-informed employee will never deviate any process and always work as a trustworthy soldier.

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

Benefits of Quality Culture
1. A firm having quality culture will never face any problem in any regulatory audit and the firm will not require preparing for any quality audit.
2. Employees will not get frustrated and have satisfaction for their work hence they will feel engaged and attached to the company and they will perform better.
3. Employees will also get the benefit of the quality culture in terms of their promotions, salary hikes and better opportunities.
4. When every pharmaceutical company in a nation will have quality culture, it will improve the reputation of the nation in the regulatory market.

Quality culture is a demand to survive in today's competitive regulatory market. A firm without quality culture cannot run long and has a dark future. A quality culture can easily overcome the non-compliance in the pharmaceutical industry therefore, as a pharmaceutical employee you must take this initiative today.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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