Tell me about yourself.
Don't tell them about your favorite hobbies, health issues, or how much you enjoy playing video games. This is your cue to provide a brief overview (no more than one or two minutes) of the aspects of your experience and background that relate to the position.
Tell them about some accomplishments you felt really good about, and how you think they prepared you for the position you're interviewing for.
Example: "I have six years of QC Senior Executive, and spent the past three years as the Assistant QC Manager at ABC Corp. overseeing QC schedules, staff hiring, and deadlines. During that time, I streamlined the workflow so that we were able to meet the deadline every month. Our efficiency saved the company two weeks worth of staff overtime and expenses. Time management is one of my greatest skills, and I'm sure it that would easily transfer to the QC Manager position you're offering here."
What do you think is your greatest weakness?
Don't say anything that could eliminate you from consideration for the job. For instance, "I'm slow in adapting to change" is not a wise answer, since change is par for the course in most work environments. Avoid calling attention to any weakness that's one of the critical qualities the hiring manager is looking for. And don't try the old "I'm a workaholic," or "I'm a perfectionist."
The best way to answer this question is honestly--mention a real weakness that won't affect your ability to do the job or address a skill that you are just learning and want to develop.
Example: "I'm not as strong as I'd like to be on social media, so I'm spending about three hours a week blogging on topics I'm interested in, and reading some perspectives on the business-to-business value of social media. I'm already learning some things I can bring here, and hope to find more ideas on how to use social media as a customer relationship tool."
What did you like least about your last (or current) job?
Don't vent or focus on the negative with brutally honest answers such as "My boss was a jerk," or "The company culture was too politically correct," or "They just weren't giving me the opportunity to take my career to the next level." Instead, keep the emphasis on the positive, even though there are sure to be things you weren't happy about.
Example: "That's a tough question to answer. I've had lots of opportunities at ABC Company and I work with some outstanding people. I guess if I had to pick one thing, it would be the occasional meeting that goes an hour longer than normal. I like to get stuff done and work with people and that extra hour could have let me get back to a client more quickly."
Where do you see yourself in 5 years?
Believe it or not, this question is really disguised as: "Could I count on you to stay with this company long term?"
Since no one knows exactly where they'll be five years from now, the best way to answer this is with a reply that says you hope to be well-established as someone who is helping that company succeed. You can also turn the question back to the interviewer, and ask where they see the company in five years. You might not know on a personal level where you'll be, but most companies have goals and plans that look ahead in two to five years. Their answer might give you a good idea if it's a company worth sticking around that long for.
Tell me about a time you failed.
Everyone has failed, so don't play dumb or claim you've never messed up. Think of a time when a work-related situation didn't turn out quite as you had hoped. An interviewer is interested in seeing how you took responsibility for your failure, what you learned from it, and how you would prevent similar failures from happening again.
Examples: "I once rushed a project to make a shipping deadline but inadvertently skipped a couple of critical steps. Fortunately, we discovered the mistake before the customer installed the products, but they weren't pleased. I never made that mistake again."
"I thought my aggressive sales tactics were a great quality until I lost a client for being too pushy. I've since learned to tone things down and really listen to my clients and understand their needs before determining how to help them."
What is a 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.
What are the recommended bioburden limits of purified water & WFI?
Purified water has a recommended bioburden limit of 100 CFU/mL, and water for injection (WFI) has a recommended bioburden limit of 10 CFU/100 mL.
What are significant changes in stability testing?
- A 5% change in an assay for the initial value.
- Any degradation products exceed its acceptance criterion.
- Failure to meet acceptance criteria for appearance, physical attributes, and functionality test.
- Failure to meet acceptance criteria for dissolution for 12 units.
If the leak test fails during in-process checks what needs to be done?
Immediately stop the packing process and check for
- Sealing temperature
- Verify for any possible changes like foil width, knurling, etc.
- Check & quarantine the isolated quantity of packed goods from the last passed in-process.
- Collect random samples & do a retest.
- Blisters from the leak test passed containers shall allow to go further and the rest must be deblistered/defoiled accordingly.
Which type of tablets are exempted from Disintegration testing?
Chewable Tablets
What are the common variables in the manufacturing of tablets?
- The particle size of the drug substance
- Bulk density of drug substance/excipients
- Powder load in a granulator
- Amount & concentration of binder
- Mixer speed & mixing timings
- Granulation moisture content
- Milling conditions
- Lubricant blending times
- Tablet hardness
- Coating solution spray rate
Whether the Bracketing & Validation concept can be applied in process validation?
Both Matrixing & Bracketing can be applied in validation studies.
Matrixing:
- Different strengths of the same product,
- Different sizes of the same equipment
Bracketing
- Evaluating extremes
- Largest and smallest fill volumes
- Fastest and slowest operating speeds
What is the difference between calibration and Validation?
Calibration is a demonstration that, a particular Instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.
Validation is a documented program that provides a high degree of assurance that a specific process, method, or system consistently produces a result meeting pre-determined acceptance criteria.
What are Good Manufacturing Practices (GMP)?
Good Manufacturing Practices are a set of regulations, codes, and guidelines for the manufacture of Drug substances and drug products, Medical devices, In vivo and in vitro diagnostic products, Foods.
The term "cGMP" is used by the federal government as current good manufacturing practices. By definition, "cGMP" indicates that the current GMP - which is "state of the art" - can change. "GMP" and "cGMP" are often used interchangeably and essentially they have the same meaning.
Who Enforces Good Manufacturing Practices (GMP)?
Good Manufacturing Practices are enforced in the United States by the FDA (Food and Drug Administration).
Good Manufacturing Practices are enforced in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency (MHRA)
Good Manufacturing Practices are enforced in Australia by the Therapeutical Goods Administration (TGA)
Good Manufacturing Practices are enforced in India by the Ministry of Health, multinational and/or foreign enterprises and those individuals in the following positions:
Each of the inspectorates carries out routine GMP inspections to ensure that drug products are produced safely and correctly.
Appearance Defects of Tablets During Compression Activity?
Capping: is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling.
Laminating: is the separation of a tablet into two or more distinct horizontal layers.
Sticking/filming: Sticking’ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation.
Cracking: Small fine cracks were observed on the upper and lower center surface of the tablets, or very rarely on the side wall are referred to as cracks.
Chipping: is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.
Mottling: is the term used to describe an unequal distribution of color on a tablet.
Double Impression: involves only those punches, which have a monogram or other engraving on them.
What is the standard number of rotations used for the friability test?
100 rotations.
What is the fall height of the tablets in the friabilator during friability testing?
6 inches. Tablets fall from 6 inches height in each turn within the apparatus.
Which capsule is bigger in size - size '0' or size '1'?
'0' size
Water for pharmaceutical use shall be free of heavy metals why?
Heavy metals like lead and arsenic are highly cumulative neurotoxic metals, heavy metals are not eliminated from 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.
Change in the size or shape of the original container requires any stability study?
A change in the size or shape of the original container may not necessitate the initiation of a new stability study.
Forced degradation (stress testing) Vs accelerated stability testing
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 % 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. Photostability 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.
What is the main objective 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 the 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 the number of air changes in an area?
The 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 the air flow of the individual filters. The formula is given below.
Air flow (in cfm) = Avg.air velocity in feet/Minute x Effective area of filter
Then find the Total airflow. The formula is as follows-
Total Airflow = Sum of airflow of the individual filter.
Airflow Velocity can be measured with the help of an Anemometer.
How many Tablets shall be taken for checking friability?
For tablets with unit mass equal to or less than 650 mg, take a sample of whole tablets corresponding to 6.5g. For tablets with a unit mass of more than 650mg, take a sample of 10 whole tablets.
What is the formula for calculating weight loss during the friability test?
% Weight loss = Initial Weight - Final Weight X 100/Initial Weight
What is the pass or fail criteria for the friability test?
Generally, the test is run once. If any cracked, cleaved or broken tablets are present in the tablet sample after tumbling, the tablets fail the test. If the results are doubtful, or weight loss is greater than the targeted value, the test should be repeated twice and the mean of the three tests determined. A mean weight loss from the three samples of not more than 1.0% is considered acceptable for most of the products.
What is the standard number of rotations used for the friability test?
100 rotations
What is the fall height of the tablets in the friabilator during friability testing?
6 inches. Tablets fall from 6 inches eight in each turn within the apparatus.
Why do we check hardness during in-process checks?
To determine the need for the pressure adjustments on the tableting machine. Hardness can affect the disintegration time. If the tablet is too hard, it may not disintegrate in the required period of time. And if the tablet is too soft it will not withstand handling and subsequent processing such as coating, packing etc.
What are the factors which influence tablet hardness?
- compression force
- Binder quantity (More binder more hardness)
- Moisture content
What is the recommended temperature for checking the DT of a dispersible tablet?
25 ±1°C (IP)
15 – 25°C (BP)
What is the mesh aperture of the DT apparatus?
1.8 -2.2mm (#10)
What are the pass/fail criteria for the disintegration test?
If one or two tablets/capsules fail to disintegrate completely, repeat the test on another 12 additional dosage units. The requirement is met if not fewer than 16 out of 18 tablets/capsules tested are disintegrated completely.
What are the recommended storage conditions for empty hard gelatin capsules?
15 - 25°C & 35 -55% RH
What are the recommended upward and downward movement frequency of a basket-rack assembly in a DT apparatus?
28 – 32 cycles/minute
In a tablet manufacturing facility, ‘positive’ pressure is maintained in the processing area or service corridors.
In tablet manufacturing facilities, pressure gradients are maintained to avoid cross-contamination of products through air. Usually, processing areas are maintained under positive pressure with respect to service corridors.
What checks shall be carried out while calibrating DT apparatus?
While calibrating the DT apparatus, the following checks shall be performed.
- Number of strokes per minute (Limit: 29-32 cycles/min)
- Temperature by probe & standard thermometer (Limit: 37 ± 1°C).
- Distance traveled by basket (Limit: 53 -57mm)
What is the difference between disintegration and dissolution?
Disintegration is a disaggregation process, in which an oral dosage form falls apart into smaller aggregates. (Disintegration time is the ‘break up’ time of a solid dosage form).
Whereas dissolution is a process by which a solid substance enters in the solvent to yield a solution. It is controlled by the affinity between the solid substance and the solvent.
That is why it is said that disintegration is a subset of dissolution.
Why do we calibrate qualified equipment/instruments at definite intervals?
Equipment or instrument can ‘drift’ out of accuracy between the time of qualification and actual use. So it is recommended to calibrate and recalibrate the measuring devices and instruments at predetermined time intervals, to gain confidence in the accuracy of the data.
Why do we consider three consecutive runs/batches for process validation? Why not two or four?
The number of batches produced in the validation exercise should be sufficient to allow the normal extent of variation and trends to be established and to provide sufficient data for evaluation and reproducibility.
- First batch quality is accidental (co-incidental),
- The second batch quality is regular (accidental),
- The third batch quality is validation (confirmation).
In 2 batches we cannot assure the reproducibility of data, 4 batches can be taken but the time and cost are involved.
Explain about revalidation criteria of AHU system.
AHU system shall be revalidated periodically as mentioned in the regulatory standards. AHU shall be revalidated in the following cases also.
- When the basic design of AHU is changed,
- When clean room volume is changed,
- When new equipment is installed
- When construction is carried out, that calls for a reconstruction of AHU system.
What needs to be checked during AHU validation?
During AHU validation, the following tests shall be carried out
- Filter efficiency test,
- Air velocity & number of air changes,
- Air flow pattern (visualization)
- Differential pressure, temperature, and RH
- Static condition area qualification
- Dynamic condition qualification
- Non-viable count
- Microbial monitoring
- Area recovery and power failure study
Which capsule is bigger in size - size '0' or size '1'?
'0' size
Define the process flow of API manufacturing.
Define the process flow of Tablet manufacturing.
Define the process flow of Sterile Lyophilized manufacturing.
Define the process flow of Biotech product manufacturing.
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