Author : Prajjual MAKHAIK
Publisher : Unknown
Page : 74 pages
File Size : 55,8 Mb
Release : 2019-04-03
Category : Electronic
ISBN : 1092616098
Pharmaceutical Industry Interview Frequently Asked Questions by Prajjual MAKHAIK Pdf
PHARMACEUTICAL INDUSTRY INTERVIEW FREQUENTLY ASKED QUESTIONS1. What is an SOP?A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by step outline form how to perform a particular task or operation. Everyone in a company must follow the same procedures to assure that tasks are performed consistently and correctly. Most companies have a wide variety of SOPs that describe how to do different tasks. In many companies technicians and operators are trained in how to follow individual SOPs and their training record specifies which SOPs they are trained on and are authorized to use.2. What is 21 CFR part 11?Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.3. What are user Requirements ?User Requirements Specification describes what users require from the System. UserRequirement specifications are written early in the validation process, typically before the system is created. It is written by the System Owner and End Users, with input from Quality Assurance. Requirements outlined in the URS are usually tested in the Performance Qualification. User Requirements Specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirements outlined in the URS.4. What is a validation plan?Validation Plans define the scope and goals of a validation project. Validation plans are written before a validation project and are specific to a single validation project. Validation Plans can include:Deliverables (Documents) to be generated during the validation process Resources/Departments/Personnel to participate in the validation project Time-Line for completing the validation project.
