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The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change. According to the Project Management Institute , change control is a "process whereby modifications to documents, deliverables, or baselines ...
The authority of the Change Control Board may vary from project to project (see e.g. Consensus-based decision making), but decisions reached by the Change Control Board are often accepted as final and binding. A typical Change Control Board might consist of the development manager, the test lead, and a product manager.
In configuration management, a baseline is an agreed description of the attributes of a product, at a point in time, which serves as a basis for defining change. [1] A change is a movement from this baseline state to a next state. The identification of significant changes from the baseline state is the central purpose of baseline identification.
Configuration change control is a set of processes and approval stages required to change a configuration item's attributes and to re-baseline them. Configuration status accounting is the ability to record and report on the configuration baselines associated with each configuration item at any moment of time.
A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organization in the pharma industry, is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive ...
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
PDCA or plan–do–check–act (sometimes called plan–do–check–adjust) is an iterative design and management method used in business for the control and continual improvement of processes and products. [1] It is also known as the Shewhart cycle, or the control circle/cycle. Another version of this PDCA cycle is OPDCA. [2]
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.