Life Science and Pharmaceuticals

Set of steps to solve problems or implement improvements.

Founded in 1940, this organization is responsible for technical standardization in Brazil. Its standards aim to standardize processes, products, and services to ensure greater quality, safety, and efficiency.

Workplace organization and cleanliness method.

A method for identifying root causes by asking 'why?' five times. Typically included in the 8D process.

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.

Substance that provides a medicine with its intended pharmaceutical effect.

Harmful, unintended, and undesirable response to a medication.

Any unfavorable medical occurrence in a patient or participant in a clinical study.

The Brazilian regulatory body responsible for the regulation and oversight of medicines, vaccines, medical devices, pesticides, food, and cigarettes.

Technology that uses advanced algorithms and machine learning to analyze data, predict outcomes, and optimize production processes, improving efficiency, quality, and real-time decision-making.

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

The analysis of large volumes of data to improve efficiency and quality.

Management of the list detailing all components of a product.

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

Biologically similar drugs to approved reference products.

A procedure in clinical studies where one or more parties are unaware of the treatment assignment.

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The process of adjusting instruments to ensure accurate measurements.

A methodology that identifies, analyzes, and establishes corrective and/or preventive actions, allowing for the correction and prevention of problem recurrence.

The ability of a process to consistently meet product specifications and tolerances.

A document used to record all information required by a clinical study protocol.

Document certifying that a product complies with technical specifications.

Entity responsible for evaluating and certifying the compliance of products and systems with specific standards.

Process by which a third party (certification body) assesses and verifies that a product, service, process, or system meets specific normative or regulatory requirements. Certification is carried out based on specific standards and may include audits, inspections, testing, and other evaluation methods.

Process that assesses and mitigates risks associated with changes in processes, systems, or documentation.

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.

Adherence to legal, regulatory, customer, and internal requirements.

A documented process that verifies that a computerized system performs as designed for its intended use in an integral and reproducible manner.

Immediate action to control or limit an identified problem.

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

Company contracted to carry out activities related to clinical trials.

A measure or intervention adopted to eliminate the causes of a nonconformity, defect, or undesirable situation, with the aim of preventing its recurrence.

Repairs performed after failures occur.

Expenses related to errors, rework, and failures that impact quality.

Negative feedback from customers regarding provided products or services.

A graphical tool used to identify critical control points (CCPs) in food safety systems.

Failure to meet an established requirement.

A process to confirm that an action taken was effective.

The process of removing or reducing pollutants in liquid waste generated by a manufacturing unit according to established standards before disposal or reuse.

Set of laws regulating and controlling the amount of pollutants that can be emitted by a source, whether mobile or stationary.

Practices to reduce energy consumption in production.

Documents that assess and record the effects of an industrial activity on the environment.

Process that certifies, through a series of evaluations, that equipment meets its intended use with integrity and reproducibility.

The study of worker efficiency and comfort on the production line. It also includes actions to adapt the work environment for employee comfort and safety.

The European regulatory body responsible for the scientific evaluation, supervision, and safety control of medicines.

Management of finished product transportation to customers.

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

The U.S. regulatory agency responsible for the safety and efficacy of drugs and food.

FDA regulation on electronic records and electronic signatures.

FDA regulation that establishes the basic requirements applicable to medical device manufacturers.

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

'First In, First Out' inventory management method, where the oldest products are used first.

Finalized item ready for customer delivery.

An internal audit conducted by the organization itself or by an entity on its behalf, aimed at evaluating the conformity of its own systems, processes, and procedures.

A graphical representation of process steps, used to map and analyze production processes.

Coordination of all processes involved in product production and delivery.

A set of standards and procedures that ensure the quality of data generated in laboratories. GLPs cover the entire testing process, from sample preparation to the generation of final reports.

A set of guidelines that ensure the quality and safety of pharmaceutical products during production.

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

Investigation of the causes of workplace failures to implement corrective and preventive measures.

Verification of compliance for materials received from suppliers.

Integration of digital technologies in industrial production.

The use of information systems to support production operations.

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

Management of material flow within the factory.

Connection of devices and systems to collect and share data.

Verification of material or product stock quantities against system records.

A diagram used to identify potential causes of a problem.

International standard for quality management systems in medical devices.

International standard setting guidelines for corporate environmental management.

International standard defining requirements for occupational health and safety management systems (OHSMS).

Standard specifying risk management for medical devices.

International standard for quality management systems.

Continuous improvement philosophy, part of Lean Manufacturing.

Visual tool for controlling and managing production flow.

Metrics used to evaluate success in quality and production processes.

Set of legal regulations governing the production and commercialization of goods and services.

Physical arrangement of machines, equipment, and workstations on the factory floor to optimize production flow.

Total time required to transform an order into delivery, from start to finish.

Production system aimed at eliminating waste and increasing process efficiency.

Production system aiming for maximum efficiency with minimal waste.

A company or individual responsible for producing goods or products from raw materials. The manufacturer is responsible for the entire production process, from product conception to final delivery to the customer, ensuring quality and compliance with applicable specifications and standards.

Software used to monitor and control manufacturing operations.

System that plans the acquisition and use of materials, aligning inventories with production needs.

Failure to meet a specified requirement or standard procedure.

Employee training to prevent accidents and comply with workplace safety regulations.

A technique that helps prioritize improvement actions based on the 80/20 principle.

Continuous improvement cycle used in various processes.

Set of pharmaceutical codes establishing minimum quality requirements for pharmaceutical inputs, medicines, and healthcare products (e.g., European, U.S., or Brazilian pharmacopoeia).

Monitoring adverse effects and drug safety.

Selection of items from inventory to fulfill orders.

Batches produced to verify process and equipment suitability before large-scale production.

Control of the supply, use, and maintenance of Personal Protective Equipment (PPE).

A document recording the issuance and use of Personal Protective Equipment by employees.

Technique to predict equipment failures before they happen.

The use of technology to increase efficiency, reduce errors, and improve product quality and compliance.

Use of virtual models to test and optimize production processes.

A set of activities proving that a process can consistently produce products of predefined quality in an integral and reproducible manner.

The process of creating and improving new products and components.

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

Evaluation of product durability and safety over time.

Planning and execution of development and production projects.

Initial models of a product created for testing and validation before large-scale production.

Creation of initial product models for testing and validation.

Systematic approach to product development, establishing comprehensive requirements throughout the entire production chain to ensure higher quality, efficacy, and safety.

Record of problems related to product or service quality.

Inspection of products to ensure compliance with specifications.

Procedure to examine activities and ensure compliance with quality requirements set by regulatory and standardization bodies.

A formalized system documenting processes, procedures, and responsibilities to achieve quality policies and objectives.

Inspection and testing to ensure product compliance.

Material used as an input in product manufacturing.

Process aimed at creating and improving products, technologies, and processes to meet market demands or innovate.

Process of returning products or waste for recycling, disposal, or reuse.

Ongoing process aimed at identifying, analyzing, evaluating, prioritizing, mitigating, and monitoring events that may affect an organization's objectives.

Use of robots to automate production processes.

An analysis method to identify the primary cause of a nonconformity or food safety issue.

A methodology used to identify the root cause of problems.

Regular evaluations to identify and correct workplace hazards.

The range of measures taken to correct or improve processes.

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Products that have undergone part of the production process but are not yet finalized.

A scientific discipline used to evoke, measure, analyze, and interpret reactions to the characteristics of food and materials as perceived by the senses of sight, smell, taste, touch, and hearing.

Production area where products are manufactured.

A process improvement methodology focused on defect reduction.

Document establishing technical requirements and criteria to ensure product and service quality and safety.

Detailed instructions for performing specific tasks consistently and safely.

A technique that uses statistical methods to monitor and control production process quality.

Coordination and evaluation of suppliers within the supply chain.

Process of evaluating and selecting suppliers based on quality and risk criteria, also known as supplier approval.

Coordination of all processes involved in product production and delivery.

Practices aimed at minimizing the environmental impact of production.

The process of transferring knowledge and manufacturing processes from one location to another.

Monitoring and adjusting these critical parameters during industrial processes to ensure quality and efficiency.

An independent external audit conducted by a third-party entity, such as a certification body, to verify an organization's compliance with specific standards and regulations, usually with the aim of obtaining certification.

The group of executives responsible for the strategic and operational management of a company.

Strategy to maximize equipment efficiency.

Ability to track the origin and history of a product and/or critical information throughout its entire lifecycle.

Lean tool used to identify and eliminate waste in production processes.

Visual verification of parts or products to identify defects.

Planning and execution of strategies to minimize, reuse, or dispose of waste in an environmentally responsible manner.

Document detailing step-by-step procedures for performing a specific task.

Practices and regulations to ensure worker safety.