Business Management Glossary

The process by which a competent institution or body attests to the technical competence of a company to provide a service or supply a product.

A procedure conducted to assess the conformity of activities with standards and regulations.

A comparative study between generic drugs and their brand-name equivalents.

A collection of international food standards, guidelines, and codes of practice aimed at promoting food safety, protecting consumer health, and facilitating international food trade by ensuring the harmonization of food regulations and standards worldwide.

A drug registration dossier for regulatory submission.

Any undesirable substance present in food as a result of environmental contamination or equipment used in food processing and/or preservation.

A continuous improvement process focused on Lean Manufacturing, aiming to reduce costs and enhance processes and services.

Repairs performed after failures occur.

A preventive methodology that identifies and evaluates potential failures in processes, products, or systems before they occur.

FDA regulation on electronic records and electronic signatures.

'First Expired, First Out' inventory management method, where products with the nearest expiration date are used first.

Any substance or combination of substances, whether solid, liquid, pasty, or in another appropriate form, intended to provide the human body with the necessary elements for its formation, maintenance, and development.

Ingredients added in small quantities to food during processing. They modify or preserve physical, chemical, biological, or sensory properties (color, shine, odor, taste, and texture).

Coordination of all processes involved in product production and delivery.

The agency responsible for overseeing and controlling products and services that impact public health.

Any substance used in the manufacture or preparation of food and that remains in the final product, even if modified. Includes food additives.

International standard for quality management systems.

Monitoring adverse effects and drug safety.

The stages a product goes through, from conception to market discontinuation.

Total Quality Management (TQM) is a comprehensive management philosophy and approach focused on long-term organizational success through customer satisfaction. At its core, it is an integrative system that engages all employees in the continual improvement of processes, products, and services.

This approach is built on key principles, including a primary focus on meeting customer expectations, the active involvement of all employees, and a commitment to fact-based decision-making. TQM emphasizes a strategic, process-oriented approach where effective communication binds these elements together to foster a culture of quality.

Council for the harmonization of technical requirements for pharmaceuticals for human use.