Biopharmaceutical

Here are the top interview questions for Biopharmaceutical Professionals, the questions are submitted by professionals to help you to ace the job interview.

Q.1 What is a SOP?
We define Standard Operating Procedure (SOP) as a certain type of document that describes in a step-by-step manner.
Q.2 What do you understand by 21 CFR Part 11?
Title 21 CFR Part 11 of the Code of Federal Regulations primarily deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
Q.3 What do you understand by User Requirements ?
We define User Requirements Specification describes the users requirement from the System. Such that the user requirement specifications are written early by the System Owner and End Users, with input from Quality Assurance in the validation process, typically before the system is created. User Requirements Specifications are not to be treated as a technical document; such that readers with basic knowledge of the system should be able to understand the requirements outlined in the URS.
Q.4 What do you understand by a Validation Plan?
Validation Plans described the scope and goals of a validation project. Such that the Validation plans are written before a validation project and are specific to a single validation project. Validation plan includes - Deliverables, Resources to participate and time frame for validation project.
Q.5 What is an IQ document?
Installation Qualifications (ID) document refers to the collection of test cases used to verify the proper installation of a System. The Design Specification defines the requirement to properly install the system. Such that the installation qualifications must be performed prior to the completion of Operational Qualification and Performance Qualification.
Q.6 What is a Dead Leg?
We can define dead leg as an area in a piping system where liquid can become stagnant and not be exchanged during flushing.
Q.7 What does pharmacodynamics, studies?
Pharmacodynamics, studies mode of action of drugs or biochemical and physiological effects Of drugs.
Q.8 What is the first step in recombinant DNA technology process?
The first step in recombinant DNA technology process is choosing the cloning vector.
Q.9 What are the characteristics of Saccharomyces cerevisiae?
The characteristics of Saccharomyces cerevisiae are: 1. Gras-Listed Organisms 2. Grow Relatively Quickly 3. Grow In Inexpensive Media
Q.10 Which drugs are designed for sublingual administration?
Following drugs are designed for sublingual administration: 1. Cardiovascular Drugs 2. Steroids 3. Barbiturates
Q.11 What is Activase?
Activase is an enzyme serine protease which has the property of fibrin-enhanced conversion of plasminogen to plasmin.
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