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GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries , for example good agricultural practice , or GAP.
Process validation involves a series of activities taking place over the lifecycle of the product and process.". [4] A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient ...
Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation; Collectively, these and other good-practice requirements are referred to as "GxP" requirements, all of which follow similar philosophies. Other examples include good guidance practice and good tissue practice.
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.
Prior to implementing ISO 14001, an initial review or gap analysis of the organization's processes and products is recommended, to assist in identifying all elements of the current operation, and if possible, future operations, that may interact with the environment, termed "environmental aspects". [14]
Some companies are taking a risk-based approach to validating their GAMP system if one understands the regulatory requirements very well while the most of others follows the conventional process [56] [57] It is a part of GxP management. The aspects of validation and verification are even more intense and emphasized if an OOS occurs. [58]
A husband and wife who were in the process of getting divorced have died in an alleged murder-suicide in Mississippi, according to reports. Police were called in after other family members ...
Good engineering practice (GEP) is engineering and technical activities that ensure that a company manufactures products of the required quality as expected (e.g., by the relevant regulatory authorities). Good engineering practices are to ensure that the development and/or manufacturing effort consistently generates deliverables that support ...
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