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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.
Good pharmacovigilance practice (GVP), for the safety of produced drugs; 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 ...
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
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.
It provides a formula for improved documentation of many aspects of dental lab activity (from dental prescriptions to material traceability). [6] DAMAS standards mirror the FDA's quality system and good manufacturing practice standards, which all domestic dental laboratories must comply with. [7]
Since 1990, the Food and Drug Administration (FDA) has required that medical device manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30). At a high level, this regulation requires:
When the FDA observes a deviation from acceptable practice, they give the organization an opportunity to take voluntary and prompt corrective action before initiating an enforcement action. A step in this process, depending on the nature of the violation, is to issue a warning letter, which also establishes prior notice.
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...