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Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]
The seven basic tools of quality are a fixed set of visual exercises identified as being most helpful in troubleshooting issues related to quality. [1] They are called basic because they are suitable for people with little formal training in statistics and because they can be used to solve the vast majority of quality-related issues.
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.
Both free and paid versions are available. It can handle Microsoft Excel .xls and .xlsx files, and also produce other file formats such as .et, .txt, .csv, .pdf, and .dbf. It supports multiple tabs, VBA macro and PDF converting. [10] Lotus SmartSuite Lotus 123 – for MS Windows. In its MS-DOS (character cell) version, widely considered to be ...
Preventive action is any proactive method used to determine potential discrepancies before they occur and to ensure that they do not happen (thereby including, for example, preventive maintenance, management review or other common forms of risk avoidance). Corrective and preventive actions include stages for investigation, action, review, and ...
Simple example of a process control chart, tracking the etch (removal) rate of Silicon in an ICP Plasma Etcher at a microelectronics waferfab. [1] Time-series data shows the mean value and ±5% bars. A more sophisticated SPC chart may include "control limit" & "spec limit" % lines to indicate whether/what action should be taken.
Microsoft Excel is a spreadsheet editor developed by Microsoft for Windows, macOS, Android, iOS and iPadOS.It features calculation or computation capabilities, graphing tools, pivot tables, and a macro programming language called Visual Basic for Applications (VBA).
The GAMP 5 standard recommends an approach to the creation of the plan. [3]Topics commonly covered include: Introduction, scope, responsibilities, description of facility and design, building and plant Layout, cleanrooms and associated controlled environments, storage areas, personnel, personnel and material Flow, water and solid waste handling, infrastructure and utilities, water system ...