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Operators must be trained to carry out and document procedures. Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected.
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.
The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer. One can search by the “company name, location, or certificate number and find details on the types of products or activities that the company conducts and the date of the most recent GMP inspection.” [ 3 ]
In the UK, computer validation is covered in Annex 11 of the EU GMP regulations (EMEA 2011). The FDA introduced 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997). The FDA regulation is harmonized with ISO 8402:1994, [6] which treats "verification" and "validation" as separate and distinct terms.
A root cause is the identification and investigation of the source of the problem where the person(s), system, process, or external factor is identified as the cause of the nonconformity. The root cause analysis can be done via 5 Whys or other methods, e.g. an Ishikawa diagram.
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).
Data Analysis Expressions (DAX) is the native formula and query language for Microsoft PowerPivot, Power BI Desktop and SQL Server Analysis Services (SSAS) Tabular models. DAX includes some of the functions that are used in Excel formulas with additional functions that are designed to work with relational data and perform dynamic aggregation.
Microsoft Office Excel – for MS Windows and Apple Macintosh. The proprietary spreadsheet leader. Microsoft Works Spreadsheet – for MS Windows (previously MS-DOS and Apple Macintosh). Only allows one sheet at a time. PlanMaker – for MS Windows, Linux, MS Windows Mobile and CE; part of SoftMaker Office