Overview: Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform, and are a vital component of ensuring compliance with regulatory agency requirements for
This SOP describes the types of laboratory workbooks, the GMP requirements for using workbooks, analytical data entry in the workbook, and the formatting of laboratory workbooks for routine testing and trials. Creation of Certificate of Analysis This procedure defines the content and format of a Cert...
Writing an SOP is challenging and requires deep insight into how to analyze processes and how to describe and visualize them. The SOP system in its entirety should appear in a harmonized and standardized format. Preferably an SOP writer is recommended, who acts as moderator and even as change ...
5.1.1Audit Objective:Write audit objective in this column. Audits objective may be but not limited to one or more of the following. 5.1.1.1 To determine the conformity or nonconformity of the quality system elements with specified requirements. 5.1.1.2 To determine the effectiveness of the imple...
SOP development is not that hard! Get started with SOP Templates, Forms, Checklists, Analysis Techniques and Global References. Customize according to your organization in an easy-to-edit format. Choose your domain and we will deliver the templates in a week’s time. ...
”Or,anotherdefinitionis“detailedwritten12 instructionstoachieveuniformityoftheperformanceofaspecific13 function.”14 Ifyouareamedicaldeviceorpharmaceuticalmanufacturer,thisisno15 surprisewithFDAbecause“establish”meanstodefine,todocument(in16 writingorelectronically)andtoimplement.Thegoalandemphasiswith17 FDAis...
For many of us, Excel spreadsheets are indispensable tools in the pharmaceutical industry. Depending on the use and criticality, some complex Excel spreadsheets require rigorous validation to ensure their outcomes are accurate, reliable, and consistent. ...