Unlock Knowledge

ALCOA: A commonly used acronym for “attributable, legible, contemporaneous, original and accurate” throughout the data life cycle for the defined retention period.

ALCOA+: A commonly used acronym for “attributable, legible, contemporaneous, original and accurate” which puts additional emphasis on the attributes of being complete, consistent, enduring, and available throughout the data life cycle for the defined retention period.

Audit: A systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.

Benchmarking: A technique in which an organization measures its performance against that of best-in-class organizations, determines how those organizations achieved their performance levels and uses the information to improve its own performance. Subjects that can be benchmarked include strategies, operations and processes.

Correction: Any action that is taken to eliminate a nonconformity. However, corrections do not address the causes.

Corrective Action: Steps that are taken to eliminate the causes of existing nonconformities to prevent recurrence. The corrective action process tries to ensure that existing nonconformities and potentially undesirable situations do not happen again.

Data integrity: The degree to which data are complete, consistent, accurate, trustworthy, and reliable and to which these characteristics of the data are maintained throughout the data life-cycle.

Effectiveness: An expression of the degree to which activities have produced the effects planned.

Efficiency: The relationship between the results of activities and the corresponding effort expended in terms of money, resources, and time.

Failure Mood and Effect Analysis (FMEA): is a systematic approach used to identify and prevent possible failures in a design, manufacturing process, or a product or service.

Gantt Chart: is a bar chart that illustrates a project schedule. It shows the start and end dates of project tasks and the dependencies between them.

Good manufacturing practices (GMP): That part of quality assurance that ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

Histogram: a visual representation of data points that are grouped into user-defined ranges. It is similar to a bar graph, but instead of each bar representing a single category, each bar in a histogram represents a range of values. The height of the bar represents the number of data points that fall within that range.

Ishikawa diagram: also known as a fishbone diagram, cause-and-effect diagram, or herringbone diagram, is a visual tool used to identify the potential causes of a specific problem or event.

Just in time: is an approach to production scheduling that focuses on delivering materials and components at the exact time they are needed for the production process, thus reducing inventory holding costs and waste. This method is different from traditional manufacturing methods that stockpile large amounts of raw materials and finished goods, leading to unnecessary storage costs and potential obsolescence.

Key Performance Indicator (KPI): is a measurable value that helps to track the effectiveness of a company or individual in achieving its goals. KPIs are crucial for organizations of all sizes since they provide a means to measure progress, identify areas for improvement, and make decisions based on data.

Lean manufacturing: a methodology that focuses on streamlining production processes by identifying and eliminating waste, as well as improving efficiency. This is done through a continuous process of analyzing each step of the production line, identifying anything that does not add value to the customer, and eliminating it. This can range from unnecessary steps in the production process to excess inventory. The goal is to create a more efficient and effective production process that benefits both the company and the customer.

Management Review: A formal evaluation conducted by top management to assess the performance of a quality management system, identify areas for improvement, and make strategic decisions.

Master Validation Plan (MVP): A document outlining the validation approach for processes, systems, or equipment, providing an overview of validation activities and timelines.

Method validation: is conducted where non-compendial analytical methods are included in the application to confirm that the applicant’s proposed analytical methods are suitable for its purposes.

Method verification: is conducted where the methods are compendial, to confirm whether the product as compounded can be analyzed satisfactorily by the official method.

Quality Assurance (QA): The process of ensuring that a product or service meets the specified standards or requirements

Quality Control (QC): The process of inspecting, testing, or evaluating a product or service to ensure that it meets the specified standards or requirements

Quality Management System (QMS): Is a framework of policies, processes, and procedures that an organization uses to ensure it consistently meets customer requirements and enhances customer satisfaction.

Risk: The combination of the probability of occurrence of harm and the severity of that harm.

Risk management: The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk.