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Corrective and preventive action (CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems ...
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 FDA has outlined a regulatory framework [1] for PAT implementation. With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the ...
All guidelines follow a few basic principles: [2] [6] Manufacturing facilities must maintain a clean and hygienic manufacturing area. Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
Where appropriate, the reason for alteration must be noted [1]: ¶4.9 [2] [3] [7] Controls exist to prevent the inadvertent use of superseded documents [3] [9] Electronic versions can only be modified by authorized personnel [2] A history (audit trail) must be maintained of changes and deletions to electronic versions [2] [4] [5]
Like medicine, accounting, and engineering, quality has achieved status as a recognized profession. [2] As Lee and Dale (1998) state, there are many organizations that are striving to assess the methods and ways in which their overall productivity, the quality of their products and services and the required operations to achieve them are done. [3]
Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
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 ...