The 8 Essential Elements of Quality Management for Pharmaceutical Companies

Within an organization, quality assurance serves as a management tool. In contractual situations, quality assurance also serves to generate confidence in the supplier. In the drug industry at large, quality management is usually defined as the aspect of management function that determines and implements the “quality policy.

A quality Management system helps to improve product quality and lower the risk of a product recall. The pharmaceutical market has undergone significant changes to focus on the need and the internal efficiency to continue to compete. So, this supports the pharmaceutical industry to enhance the quality and availability of medicines around the world. Through the regulation of quality, management organization facilitates innovation along with continual improvement as well as strengthens the link between the Pharmaceutical development and manufacturing activities.

 

Key Elements of Quality Management for Pharma Company

Some of the important elements of total quality management are: 

Quality assurance

 “Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. All the pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP

Good manufacturing practices for pharmaceutical products

 Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production. 

 Customer Satisfaction

 In the present era, the customer is the king. It must be recognized that customers are the most important persons in any business. The very existence of an organization depends on them. They are the lifeblood of business and deserve the most courteous and affectionate treatment. 

 Sanitation and hygiene

 A high level of sanitation and hygiene should be practiced in every aspect of the manufacture of drug products. The scope of sanitation and hygiene cover personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamination to the product. 

Total Employee Involvement

Involvement of employees means that every employee is completely involved in every step of the production process which plays an active role in helping the organization to meet its targets

Continuous Improvement

 

Continuous improvement is critical to the success of organizations in any industry. For pharma companies, constant improvement is likely imperative to survival. The pharmaceutical industry is under intense pressure to meet strict regulatory requirements and pricing pressures while evolving to meet changing customer expectations.

 

Factual approach to decision making

 

Organizations succeed when they have established an evidence-based decision-making process that entails gathering input from multiple sources, identifying facts, objectively analyzing data, examining cause/effect, and considering potential consequences.


Strategic and Systematic Approach


A strategic approach to pharma leadership allows a company to become more forward-thinking. In a pharma company, the leadership team is tasked with creating a culture of quality and inspiring excellent performance. 

 

Conclusion

 

These elements help an organization to effectively implement total quality and ensure they meet all the requirements of its customers. This helps them to focus on customer satisfaction and can help in the growth of the organization.

 

 

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