Most frequent questions asked in Quality Assurance Interview Pharmaceuticals
Q1. What is change control? Types of change control
Answer: When a change is being made in any process or procedure it is reported by change control procedure and that is approved by the company authority. Change control is used to control the changes made in the pharmaceutical industry.
Change control can be major or minor.
Q2. What is deviation? Types of deviations
Answer: Deviations are measured differences between observed value and expected or normal value for a process or product condition, or a departure from a documented standard or procedure.
There are two types of deviations 1) Planned Deviation. 2) Unplanned Deviation.
Q3. What is market complaint? Types of market complaints.
Answer: ‘Complaint’ is defined as a statement that something is wrong or not good enough. Generally, in the pharmaceutical industry, com- plaints are regarding the quality of drug product.
Classification of Complaints.
Critical complaints: Which can definitely cause a serious health injury or even death of patient, In this case product is required to be withdrawn from the market.
Major complaints Which may have any negative impact on the health of consumer. In this case, recall of the product is depend upon the severity of the complaint.
Minor Complaints: Which do not have any negative impact on the health of consumer. In this case, there is no requirement of recall.
Q4. Definition of process validation?
Answer: Process Validation is defined as the. collection and evaluation of data, from the. process design stage throughout. production, which establishes scientific evidence that a process is capable of consistently delivering quality products. for detail Process Validation through New Guideline
Q5. What is Equipment qualification?
Answer: Qualification can be defined as “establishing documented evidence which provides a high degree of assurance that specific equipment procured will consistently produce its predetermined specification and quality attributes”. Qualification term is qualifying an equipment based on URS.(user requirement specification).
Validation phases are DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification).
Q6. Types of product Recall?
Answer: There is three types of recalls. Depending on the product’s degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend.
In general, Class I recalls may extend to the consumer or user level, Class II recalls may extend to the retail level, and Class III recalls may extend to the wholesale level.
Q7. Cleanroom definition?
Answer: A clean room (or cleanroom) is an enclosed space in which airborne particulates, contaminants, and pollutants are kept within strict limits.
Q8. What is HEPA filter?
Answer: HEPA stands for high-efficiency particulate air. A HEPA filter is a type of mechanical air filter; it works by forcing air through a fine mesh that traps harmful particles such as pollen, pet dander, dust mites, and tobacco smoke.
common standards require that a HEPA air filter must remove—from the air that passes through—at least 99.95% (European Standard) or 99.97% (ASME, U.S. DOE) of particles whose diameter is equal to 0.3 μm; with the filtration efficiency increasing for particle diameters both less than and greater than 0.3 μm.
Q9. What instrument use is to test Air velocity?
Answer: An anemometer is an instrument used to measure the speed or velocity of air (gases) either in a contained flow, such as airflow in a duct, or in unconfined flows, such as atmospheric wind.
Q10. What instrument use is to test Filter Integrity?
Answer: Aerosol Photometer
Q11.What is cleaning validation?
Answer: Cleaning validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active, inactive or detergent ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.
Q12.What is the Site Master File?
Answer: A site master file is a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings.
Q13.What is ALCOA+ in data integrity?
Answer: The term ALCOA is an acronym, which states that our data should be Attributable, Legible, Contemporaneous, Original and Accurate. Plus is expanded form of ALCOA which puts additional emphasis on the attributes of being complete, consistent, enduring and available.
Q14.What is the difference between Qualification & Validation?
Answer: Qualification and validation both are documented evidence based on scientific data to ensure that a method, system, process or equipment is produces results as per predetermined intended specification. To perform validation of method, system or process, we need certain equipment as the activity is to be performed in that equipment.
So, the activity for scientifically proving that the equipment will give constant output when operated and installed accurately shall be considered qualification, on the other hand proving scientifically that a method, system and process will provide consistent and predefined results when operated in qualified equipment shall be considered as validation.
Q15 What is the weight variations limits for tablets & capsules as per IP & USP?
Answer: For tablets
|80 mg or less||± 10%||130 mg or less|
|More than 80 mg & less than 250 mg||± 7.5%||130mg to 324 mg|
|250 mg & more||± 5%||More than 324 mg|
|Less than 300 mg||± 10%|
|300 mg & more||± 7.5%|
Q16.How do you check friability of tablets?
Answer: Remember friability test is official in USP but not in IP & BP.
For tablets weight equal to or less than 650 mg, take tablets corresponding to weight 6.5 g. For tablets with a unit mass more than 650 mg take a sample of 10 tablets. Dedust the tablets prior to testing.
Accurately weigh the tablets and place in the drum. Rotate the drum for 4 minutes/100 times. Remove the tablets from drum. Remove the dust from tablets as before and reweigh.
Calculate the friability in percent by deduct final weight from initial weight and divide it by initial weight and finally multiply by 100.
Q17.How many strokes does a disintegration apparatus take in one minute?
Answer: 28-32 cycle (strokes)per minute as per IP.
29-32 cycle (strokes)per minute as per BP/USP.
Q18.What is the disintegration time for different tablets?
Answer: Below is the list of different types of tablets and their corresponding D.T.
|Type of Tablets||Disintegration time|
|Uncoated Tablets||15 minutes|
|Coated Tablets||Film coated||30 minutes|
|Other coated||60 minutes|
|Enteric Coated Tablets||0.1 M HCl||Should not disintegrates in 120 minutes.|
|Mixed phosphate buffer pH 6.8.||60 minutes|
|Dispersible & Soluble Tablets||Within 3 minutes|
|Effervescent Tablets||5 minutes|
Q19.How many types of airlocks in a pharmaceutical manufacturing plant?
Answer: An airlock is an enclosed room design, construct and maintained between two controlled areas of different cleanliness levels to prevent the direct airflow from one controlled area to other.
Cascade: These airlocks are very common having a higher pressure on one side and lower pressure on another side of the airlock.
Bubble: These types of airlocks have a higher pressure inside the airlock and lower pressure in both outsides.
Sink: These types of airlocks have a lower pressure inside the airlock and higher pressure in both outsides.