Quality Assurance Interview Questions

26 Oct 2016 07:36 News 3 comments

What is an SOP?

. StandardOperating Procedure (SOP) is a certain typeof document that describes in a step-by-step outline form how to perform aparticular task or operation. Everyone in a company must follow the sameprocedures to assure that tasks are performed consistently and correctly. Mostcompanies have a wide variety of SOPs that describe how to do different tasks.In many companies technicians and operators are trained in how to followindividual SOPs and their training record specifies which SOPs they are trainedon and are authorized to use.

What is 21 CFR parts 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

What are user requirements?


User Requirements Specification describes what users require from the System. User requirement 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.

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

What is an IQ document?


Installation Qualifications are a collection of test cases used to verify the proper installation of a System. The requirement to properly install the system was defined in the Design Specification. Installation Qualifications must be performed before completing Operational Qualification or Performance Qualification.

What is an OQ Document?


Operational Qualifications are a collection of test cases used to verify the proper functioning of a System. The operational qualification tests requirements defined in the Functional Requirements. Operational Qualifications are usually performed before the system is released for use.

What is a PQ Document?


Performance Qualifications are a collection of test cases used to verify that a System performs as expected under simulated real-world conditions. The performance qualification tests requirements that were defined in the User Requirement Specification (or possibly the Functional Requirements). Due to the nature of performance qualifications, these tests are sometime conducted with power users as the system is being released.

What is a Validation Summary Report?


Validation Summary Reports provide an overview of the entire validation project. When regulatory auditors review validation projects, they typically begin by reviewing the summary report. The validation summary report should include:
 A description of the validation project
    All test cases performed, including if those test cases passed without issue
    All deviations reported, including how those deviations were resolved 

What is a Change Request?


Change Control is a general term describing the process of managing how changes are introduced into a controlled System. In validation, this means how changes are made to the validated system. Change control is required to demonstrate to regulatory authorities that validated systems remain under control after system changes. Change Control systems are a favorite target of regulatory auditors because they vividly demonstrate an organization capacity to control its systems.

Why water for pharmaceutical use is always kept in close loop in continuous circulation ?


Water is a best medium for many microorganisms, microorganism can be a highly pathogenic which causes serious diseases(many diseases are  water born), these pathogens infect after consumption of contaminated water, microorganisms tend to settle on a surface if water is allowed to stand in a stagnant position for few hours, these settled microorganism form a film over the surface of vessel and piping, such film formed by microorganisms is also called as biofilm, biofilms are very difficult of remove, once a biofilm is formed at a particular point then that point may form a biofilm again even after cleaning very easily as seed from this point is may not completely get removed effectively.

Biofilms then can become a source of microbial contaminations; therefore purified water after collection in a distribution system is always kept in a closed loop in a continuous circulation.
A continuous circulation is also not enough at some points, therefore it is aided with high temperature range from 65 °C to 80°C, a minimum temperature of 65 °C is considered a self sanitizing, but better assurance is obtained with a temperature of 80°C .

Purified water collected should be stored in a stainless still vessel which must facilitate distribution to the point of use in a closed loop of continuous circulation, tank should be made of corrosion free material of construction, and must facilitate sanitization and easy cleaning.

Water for pharmaceutical use shall be free cations, anions and other impurities why ?


Water for pharmaceutical must be free from inorganic as well as organic impurities, minerals, and heavy metals. Some impurities like calcium, magnesium, ferrous are responsible for degradation of drug molecule, many cations like ferrous and calcium magnesium act as catalysts in degradation reaction of drug molecule, anions like chloride are highly active they participate in nucliophylic substitution reactions, where in they break a double bond between -C=C- in to a single bond as CL –CH-CH2- , which a reason why we observe that color dies tend to fed in presence of chlorine as most of the dies used are diazo compounds which has plenty of places for nucliophylic substitution reactions, which is also a reason why stability of drug is drastically affected in presence of cations and anions from mineral origin present in water.

Water for pharmaceutical use shall be free heavy metals why?


Heavy metals like lead and arsenic are highly cumulative neurotoxic metals, heavy metals are not eliminated out of our body easily like other drugs and molecules but heavy metals bind with proteins and tend to get accumulated in fatty tissues, nerve tissue is most likely to get damaged by heavy metals, heavy metal causes nervous tissue damage there for water must be free from heavy metals.

Brazil falls under which climatic zone?


Zone IVB (30 degree Celsius and  75% relative humidity)

Change in the size or shape of the original container requires any stability study?


Change in the size or shape of the original container may not necessitate the initiation of new stability study.

Forced degradation (stress testing) and accelerated stability testing are same?


Forced degradation and stress testing are not same. Stress testing is likely to be carried out on a single batch of the drug substance. The testing should include the effect of temperatures (in 10°C increments (e.g., 50°C, 60°C) above that for accelerated testing), humidity (e.g., 75 percent relative humidity or greater) where appropriate, oxidation, and photolysis on the drug substance. The testing should also evaluate the susceptibility of the drug substance to hydrolysis across a wide range of pH values when in solution or suspension. Photo stability testing should be an integral part of stress testing.

According to WHO guidelines what is the storage condition of climatic zone IVa and zone IVb?


Zone IV a: 30°C and 65% RH (hot and humid countries)

Zone IV b: 30°C and 75% RH (hot and very humid countries

Countries come under climatic zone IVb?


Brazil, Cuba, China, Brunei, Cambodia, Indonesia, Malaysia, Myanmar, Philippines, Singapore,Thailand

What is the purpose of stress testing in stability studies?


Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.

What is the formula for calculating number of air changes in an area?


Number of air changes/hour in an area is 

                   = Total Room Airflow In CFM x 60
                    Total Volume of room in cubic feet

For calculating Total Room Airflow in CFM, first calculate air flow of individual filter. Formula is given below.


Air flow (in cfm) = Avg.air velocity in feet/Minute x Effective area of filter                                                  

Then find Total air flow. Formula is

Total Air flow = Sum of air flow of individual filter.


Air flow Velocity can be measured with the help of Anemometer.

What is dead leg?


A dead leg is defined as an area in a piping system where liquid can become stagnant and not be exchanged during flushing.

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