Total Quality Management in Pharmaceutical Industry

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Introduction: Total Quality Management is a systematic approach for the continual improvement of all Organization processes, through the participation of all the staff, leading to prime quality product and services to achieve customer satisfaction
It is supported by the philosophy: “Do the right things, right first time, every time”.

Principles of Total Quality Management: The principle of TQM serves as the basis of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) required by most regulatory bodies.

1. Customer-focused: The customers are the end-user of the product or medicines and therefore all the methods and policies ought to be created keeping in mind customer’s necessities and safety as outlined by the standards or regulators.

2. Staff Involvement: All employees should participate and work towards common goals. The goal of an organization shall be clearly defined in the management documents.

3. Process-centered: The focus of the process is to improve the quality of the output that is the final product. The process follows collecting inputs from all the people involved at each step of the process and converting it into quality output by continual improvement of internal practices. This approach of TQM holds all the parties involved in the production process accountable for the overall quality of the final output (services or product).

4. Integrated system: Integration of system means creating a single organizational structure in which all the subsystem maintains its purpose and integrity. The main objective of an integrated system in the pharmaceutical industry is to create a joint documented subsystem for quality management, risk management, occupational health and safety, project management, etc., so that they can function as a unit combining interactive and interrelated processes and directs the work of its divisions to achieve the goal of the company.

5. Strategic and systematic approach: All the processes are to be managed as one coherent quality management System.

6. Continual improvement: keeping in mind changing market trends and stringent regulatory requirements. Continuous improvement in process and quality is a must requirement to meet the specification and regulatory requirements.

7. Fact-based decision-making: In order to succeed organizations need to establish evidence-based decision-making. This can be achieved by taking inputs from multiple sources, analyzing data, examining cause/effect, and considering potential risk.

8. Communications: Communication is defined as the exchange of information and understanding between two or more persons or groups. The main concept of TQM is the achievement of quality standards in products and services. This achievement is possible through effective communication.

Benefits of TQM when applied consistently over the period it helps in:

• Boost morale of all the people involved in the process
• It helps in cost reduction
• Increase Customer satisfaction
• Decrease in product recall


TQM works best in an environment where there is strong support from management.

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