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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 ...
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 ...
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form .
A change request is declarative, i.e. it states what needs to be accomplished, but leaves out how the change should be carried out. Important elements of a change request are an ID, the customer (ID), the deadline (if applicable), an indication whether the change is required or optional, the change type (often chosen from a domain-specific ontology) and a change abstract, which is a piece of ...
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 ...
In 2011 the Food and Drug Administration published a report [1] outlining best practices regarding business process validation in the pharmaceutical industry. Continued process verification is outlined in this report as the third stage in Process Validation.
Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process.CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes.