Interview questions and answers for pharma jobs (Formulation

Development & Quality Control)

Q1. What is Pre-formulation study?

- Pre-formulation study is a group of studies that focus on the physicochemical properties of a

new drug candidate that could affect the drug performance and the development of a dosage
form.

Q2. Which parameters are found out in Pre-formulation study?

Appearance, Molecular weight, Solubility, pH, Hygroscopicity, Flowability, Bulk density,

Incompatibilities etc.

Q3. What is BCS classification?

Biopharmaceutical classification system is a system to differentiate the drugs on the basis of

their solubility and permeability.

Q4. Why BCS classification is important?

BCS predict in vivo performance of drug products from in vitro measurement of solubility and
permeability.

Q5. What is the application of Henderson-Hasselbalch (HH) equation?

Henderson-Hasselbalch (HH) equation is frequently used to determine the pH of a solution.

Q6. How does high performance liquid chromatography (HPLC) work and How can
calibrate a HPLC?

High-performance liquid chromatography (sometimes referred to as high-pressure liquid

chromatography), HPLC, is a chromatographic technique that can separate a mixture of
compounds and is used in biochemistry and analytical chemistry to identify, quantify and
purify the individual components of the mixture. HPLC typically utilizes different types of
stationary phases contained in columns, a pump that moves the mobile phase and sample
components through the column, and a detector to provide a characteristic retention time for
the analyte and an area count reflecting the amount of analyte passing through the detector.

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- A HPLC can be calibrated through the following checking:
· Flow rate (pump) accuracy checking
· Gradient accuracy checking
· Pump leakage checking
· Wavelength accuracy checking
· Detector intensity (linearity)
· Auto sampler injector linearity
· Degree of reproducibility etc.

Q7. How classify ICH climate zones?

- Depending on the annual temperature and humidity, the world is divided into following
climate zones:
• I. Temperate zone: 21̊C, 45%
• II. Subtropical zone: 25̊C, 60%
• III. Hot-dry zone: 30̊C, 35%
• IVa. Hot humid zone: 30̊C, 60%
• IVb. Hot higher humid zone: 30̊C, 75%
Q8. When is intermediate stability study omitted?

If 30°C ± 2°C/, 65% RH ± 5% RH is the long-term (real time) condition, there is no intermediate
condition.

Q9. What is stress testing?

- Stress testing of the drug substance can help identify the likely degradation of 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.

- Stress testing is likely to be carried out on a single batch of the drug substance. It should
include the effect of temperatures (in 10°C increments (e.g., 50°C, 60°C, etc.) above that for
accelerated testing), humidity (e.g., 75% RH or greater)

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 Q10. Which source of Povidone mostly used?

- BASF Germany.

Q11. Which amount Povidone used as a binder?

- 2-5%

Q12. What is the combination of Ludipress?

- Lactose + Povidone K-30 + Crospovidone

Q13. Who is the manufacturer of Ludipress?

- BASF Germany.

Q14. What is TGA?

Thermo gravimetric analysis is a method of thermal analysis in which the mass of a sample is
measured over time as the temperature changes.

Q15. What’s impact of TGA on formulation development?

• - Provides information about physical phenomena (phase transition, absorption,
desorption), chemical phenomena (chemisorptions, thermal decomposition), and
solid-gas reaction (oxidation, reduction).
• - Characterize and quantify the moisture content.
• - Decomposition mechanism for various polymeric preparations.
• - Prediction of stability of drug.
Q16. What is RLD?

- Reference Listed Drug (RLD) is an approved drug product to which new generic versions are
compared to show that they are bioequivalent.

Q17. Which information’s available in RLD?

- Qualitative formulation, Coating materials, Packaging materials, Storage condition etc.

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Q18. Which parameters are determined in Preformulation study?

- Molecular weight, Hygroscopicity, Solubility, pH, Storage condition, Incompatibility etc.

Q19. Why molecular weight determination is needed for generic drug development?

- To determine the factor of an Active ingredient.

Q20. What is glass transition temperature (Tg)?

- The temperature region where the polymer transition from a hard, glassy material to a soft,
rubbery material.

Q21. What is pH dependent solubility and why it’s important?

- pH dependent solubility means the solubility of a substance depends on pH variation. In

general, dissolution of BCS class II drugs is dependent on a wide variety of physiological
factors. pH, ionic strength, and buffer capacity are three major characteristics of the GI fluids
that can affect the rate of drug release.

Q22. What do you mean by Hygroscopicity?

- Hygroscopicity is the ability of a material to interact with moisture from the surrounding
atmosphere.

Q23. What type of measurement should be taken for hygroscopic material?

• - Relative humidity should be under control (<45%).
• - Wet granulation should be omitted.

Q24. What do you mean by QbD?

- design a quality product and its manufacturing process to consistently deliver the intended
performance of the product.

Q25. What are the tools of QbD?

• Quality Target Product Profile (strength, rout of administration, PK parameters,

Sterility, Purity, Dissolution, Assay)

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 • Critical Quality Attributes (particle size, distribution, bulk density, moisture content,
and which are affect on product purity, strength, stability etc.)
• Risk Assessment: Linking Material Attributes and Process Parameters to Drug Product
CQAs
• Design Space
• Control Strategy
• Product Lifecycle Management and Continual Improvement

Q26. What do you mean by Technology Transfer?

- Transfer of new technology from the originator to a secondary user.

Q27. How can identify the physical incompatibilities of pharmaceutical formulation?

- Stress testing may identify the physical incompatibilities of new drug formulation.

Q28. Which parameters are affected by Physical and Chemical interaction of Drug-
Excipients?

- Any physical or chemical interaction between drug and excipient can affect bioavailability
and stability of drug.

Q29. Why we use cellulose derivatives in Oral solid dosage formulation?

- To control or modify the drug release profile.

Q30. How can overcome the BCS class IV material problems?

- BCS class IV drugs are generally not suitable for oral drug delivery or else some special drug
delivery technologies such as Nano-suspensions will be needed.

Q31. What is process validation?

Process validation is the analysis of data gathered throughout the design and manufacturing
of a product from validation batches to confirm that the process can reliably output products
of a determined standard.

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 Q32. What do you mean by Biosimilar (drug)?

A biosimilar is a biologic medical product that is almost an identical copy of an original product
with the same active substance that is manufactured by different company.

Q33. What is cytotoxicity?

- Cytotoxicity is the quality of being toxic to cells.

Q34. How can claim the shelf life of Pharmaceutical Product?

- Depending on the accelerated and intermediate stability study we can claim the shelf life of
a pharmaceutical product. When a product is physically and chemically stable at 6 months
accelerated study (40/75) and 12 months intermediate study (30/65) we can claim 2 years shelf
life. But if found any significant change in 12 months intermediate study we need to follow up
long term/real time study.

Q35. What do you mean by forced degradation?

- Forced degradation is a degradation of new drug substance and drug product at conditions
more severe than accelerated conditions.

Q36. What is predictable dissolution?

- Predictable dissolution is the in-vitro dissolution study. Which predicts the in-vivo
dissolution (drug release) rate?

Q37. Can SLS hamper dissolution?

- Yes, sometimes SLS can hamper the dissolution rate. Especially dissolution rate of gelatin
capsule is hampered by SLS. Clarithromycin dissolution rate also hampered by SLS.

Q38. Which co-solvents are commonly used in oral solution preparation?

- Propylene glycol, Glycerol, Ethanol, PEG.

Q39. What are common buffer salts used in oral solution preparation?

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 • - Acetates (acetic acid, sodium acetate), 1-2%
• - Citrates (citric acid, sodium citrate), 1-5%
• - Phosphates (sodium phosphate, disodium phosphate), 0.8-2%

Q40. What antioxidants are commonly used for aqueous and oil bases solution
preparation?
• - For aqueous solution: Sodium sulfite, Sodium metabisulfite, Sodium
formaldehyde sulfoxylate, and Ascorbic acid.
• - For oil base solution: Butylated Hydroxytoluene (BHT), Butylated Hydroxyanisole
(BHA), and Propyl Gallate.
• - Typically antioxidants are employed in low concentrations (< 0.2% w/w).

Q41. What types of drug excipient interactions are occurred?

• Physical interaction (Complexation, Adsorption, Solid dispersion).
• Chemical interaction (Oxidation, Isomerization, Photolysis, Polymerization).
• Biopharmaceutical interactions (Premature breakdown of enteric coat, Increase in
gastrointestinal motility, Interactions due to adjunct therapy).

Q42. For which drugs disintegration test is exempted?

- Modified or delayed release drugs

Q43. What is HLB value? And for which products it’s important?

- Hydrophilic-lipophilic balance (HLB) value is a measure of the degree to which it is

hydrophilic or lipophilic. It’s help in the selection of a proper surfactant. Especially for emulsion
and suspension preparation.

• - HLB value <10 indicate lipid soluble.

• - HLB value >10 indicate water soluble.
• - HLB value 1 to 3 indicates anti-foaming agent.
• - HLB value 3 to 6 indicates W/O emulsifier.
• - HLB value 7 to 9 indicates wetting agent.
• - HLB value 13 to 16 indicates detergent.
• - HLB value 8 to 16 indicates O/W emulsifier.

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 Q44. How do you differ between Vitamins and Minerals?

- Vitamins are organic and can be broken down by heat, air or acid. Minerals are inorganic
elements that come from the soil and water absorb by plants or eaten by animals.

Q45. How to determine difference and similarity factors of two products and what’s
effect on bioequivalent product?

• - Using the mean dissolution values from both curves at each time interval,
calculate the difference factor (f1) and similarity factor (f2).
• - For curves to be considered similar- f1 values should be close to 0, and f2 values
should be close to 100.
• - Generally, f1 values up to 15 (0-15) and f2 values greater than 50 (50-100) ensures
sameness or equivalence of the two curves.
• - At least 12 units should be used for each profile determination.

Q46. How can ensure that the bioavailability of the drug is not limited by dissolution?

- The BCS suggests that for high solubility, high permeability (class 1) drugs and in some
instances for high solubility, low permeability (class 3) drugs, 85% dissolution in 0.1N HCl in 15
minutes can ensure that the bioavailability of the drug is not limited by dissolution.

Q47. How to measure bioavailability of a product?

- Bioavailability is usually measured by the area under the blood or plasma concentration time
curve (AUC) and the maximum concentration (Cmax) respectively.

Q48. Which is identified by PK and PD parameters?

• - PK describing the relationship between dose, systemic drug concentration and

time.
• - PD describing the relation between systemic drug concentration and the effect
vs. time profile.
Q49. Why BCS is important for formulation development?

The knowledge of the BCS characteristics of a drug in a formulation can help a formulation
scientist to develop a more optimized dosage form based on fundamental mechanistic, rather
than empirical information.

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Q50. What is ANDA?

Abbreviated New Drug Application contains data that, when submitted to FDA's center for drug
evaluation and research, review and ultimate approval of generic drug product. Once
approved, an applicant may manufacture and market the generic drug product to provide a
safe, effective, low cost alternative to the American people.

Q51. What is Out of specification (OOS)?

is defined as those results of in process or finished product testing that does not comply with
the pre-determined acceptance established in drug applications, drug master files (DMFs),
official compendia, or by the manufacturer.

Q52. What is Out of trend (OOT)?

result that does not follow the expected trend, either in comparison with previous results with
other stability batches or with respect to previous results collected during a stability study.

Q53. What is Bioassay?

is an analytical method to determine the concentration or potency of a substance by its effect

on living cells or tissues.

Q54. What is Biomarker?

is defined as a measurable indicator that can be used to a particular disease state or some
other biological state of an organism.

Q55. What is Precision?

The precision of an analytical procedure refers to the closeness of agreement between a series
of measurements obtained from multiple sampling of the same homogeneous sample under
the prescribed conditions.

Q56. What is Robustness?

refer to the ability of an analytical method to remain unaffected by small, but deliberate
variations in method parameters and provides an indication of its reliability during normal
usage.

Q57. What is TOC?

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Total organic carbon (TOC) is a measure of the total amount is of carbon bound in an organic
compound and is often used as a non-specific indicator of water quality or cleanliness of
pharmaceutical manufacturing equipment.

Q58. What is the Ultraviolet-Visible (UV) spectrophotometer application?

Ultraviolet–visible spectroscopy or ultraviolet-visible spectrophotometer (UV-Vis or UV/Vis)

refers to absorption spectroscopy or reflectance spectroscopy in the ultraviolet-visible spectral
region. This means it uses light in the visible and adjacent (near-UV and near-infrared (NIR))
ranges. UV/Vis spectroscopy is routinely used in analytical chemistry for the quantitative
determination of different analyses, such as transition metal ions, highly conjugated organic
compounds, and biological macromolecules. Determination is usually carried out in solutions.

Q59. What is stress testing?

• Stress testing of the drug substance can help identify the likely degradation of 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.
• Stress testing is likely to be carried out on a single batch of the drug substance. It should
include the effect of temperatures (in 10°C increments (e.g., 50°C, 60°C, etc.) above that
for accelerated testing), humidity (e.g., 75% RH or greater)

Q60. What is Viscosity?

The measurement of a materials resistance to flow. Viscosity can determine using a
viscometer.

What is Zeta Potential?

is defined as the potential difference between the dispersion medium and the stationary layer
of fluid attached to the dispersed particle. The significance of zeta potential is that its value can
be related to the stability of colloidal dispersions (e.g., a multivitamin syrup).

Q61. What is Pyrometer?

A pyrometer is a non-contacting device that intercepts and measures thermal radiation, a
process known as pyrometry. This device can be used to determine the temperature of an
object's surface.

Pyrometer is used for many industrial applications to measure non-contact high temperature
measurements. This is also useful for temperature measurement of molten iron & steel.

Q62. What is Reference standard?

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It is a standardized substance It is used as a measurement base for similar substances. Where
the exact active substances of a new drug are not known. A reference standard provides a
calibrated level of biological effects against which new preparations of the drug can be
compared. Climate chamber: It allows investigation of the effects of a gradient in temperature
and relative humidity on a porous structure. It also used in measuring how much water it
collects or releases.

Q63. Thin layer chromatography (TLC)

It is a widely employed laboratory technique. It is used for faster and better separations. It is
also for better resolution.

Q64. What is predictable dissolution?

- Predictable dissolution is the in-vitro dissolution study. Which predicts the in-vivo dissolution
(drug release) rate?

Q65. Can SLS hamper dissolution?

- Yes, sometimes SLS can hamper the dissolution rate. Especially dissolution rate of gelatin
capsule is hampered by SLS. Clarithromycin dissolution rate also hampered by SLS.

Q66. What is Drug Master File (DMF)?

A document containing complete information on an Active Pharmaceutical Ingredient (API) or

finished drug dosage form. It may be used to provide confidential detailed information about
facilities, processes, or sources used in the manufacturing, processing, packaging, and storing
of one or more human drugs. It is known as European Drug Master File (EDMF) or Active
Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States
respectively.

Q67. What are pharmaceutical impurities?

As defined by the United States Pharmacopeial (USP), impurity is “any component of a drug
substance that is not the chemical entity defined as the drug substance and in addition, for a
drug product, any component that is not a formulation ingredient.”

Q68. What is meant by titration? What are the 4 types of titrations?

Titration, process of chemical analysis in which the quantity of some constituent of a sample
is determined by adding to the measured sample an exactly known quantity of another
substance with which the desired constituent reacts in a definite, known proportion.
4 Types of Titration:

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 • Acid-base Titrations.
• Redox Titrations.
• Precipitation Titrations.
• Complexometric Titrations.

Q69. What parameters to be checked for method validation?

• Selectivity/Specificity
• Precision
• Accuracy
• Linearity
• Range
• Stability
• Limit of Detection (LOD) and Limit of Quantitation (LOQ)

Q70. What do you mean by UPLC?

Ultra-Performance Liquid Chromatography (UPLC) is an updated version of HPLC.

Credit-https://www.pharmaspecialists.com/

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