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Within quality management systems (QMS) and information technology (IT) systems, change control is a process—either formal or informal [1] —used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)
PAT is a term used for describing a broader change in pharmaceutical manufacturing from static batch manufacturing to a more dynamic approach. It involves defining the Critical Process Parameters (CPPs) of the equipment used to make the product, which affect the Critical Quality Attributes (CQAs) of the product and then controlling these CPPs ...
Table 1: Role descriptions for the change request management process Role Description Customer: The customer is the role that requests a change due to problems encountered or new functionality requirements; this can be a person or an organizational entity and can be in- or external to the company that is asked to implement the change.
If any change is agreed upon by the committee, the change is communicated to the project team and the client, and the requirement is baselined with the change. 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 ...
A framework for gathering and analyzing data of final product quality and process consistency. Analysis should include source materials consistency and manufacturing equipment condition; and data should be collected in a format that allows for long-term trend analysis as well as intra-production quality analysis.