Questions for Microbiology Interview: Part 1

 1. What is Sterilization?

The process which destroys all the forms of microbial life including Fungus,Viruses & viable cells micro-organisms along with their spores byusing Chemical as well as Physical methods is called sterilization.

2.What are the type of sterilization?

Physical methods: Heating (Dry heat and Moist heat), Radiation, Filtration (by 0.22 micron diameter cellulose filter)

Chemical: Formaldehyde, Ethylene oxide, Methanol etc.

3.What is the difference between HEPA filter and ULPA filter?

HEPA FILTERS (High efficiency particulate air): Removes 99.97% of contaminant particles about of 0.3um diamete rsize.

ULPA FILTERS (Ultra-low particulate air): More efficient than HEPA filter removes 99.999% of contaminants of 0.12um diameter size.

4.Give some examples of Gram +ve & Gram -ve Bacteria?

Gram +ve Bacteria: B. subtilis, B. megaterium, Clostridium botulinm, Mycobacterium tb, Staphylococcus, Streptococcus, Streptomyces

Gram -ve Bacteria: E. coli, Acetobacter, Pseudomonas, Salmonella, Rickttesia

5.What is Disinfection?

The process of removing or killing the all the form of microbial life except bacterial spores is called disinfection.

6.Why 70% Isopropyl alcohol is used as disinfectant in pharmaceutical industries,why not 100%?

The Bacterial cells have proteins in their cell wall and when this protein comes in contact with the 70%IPA during disinfectant application, coagulation of proteins takes places in which denaturation of proteins occurred and after that IPA penetrate in the interior of the cell which cause lysis or death of the cell. 

Protein coagulation also happens in case of 100% IPA but with very fast rate and because of this very fast protein coagulation process denatured protein forms protective layer outside of the cell. When this happens, 100% can not penetrate inside the cell and not able to kill the microbe.

7.What are antiseptics?

Antiseptics are the chemical substances which are used in destroying disease causing microorganisms (also called pathogens) externally on wounds or applied on skin surface to treat infection.

8.What is C.F.U?

A colony-forming unit(CFU) is a unit that is used to estimate the number of viable bacteria or fungal cells in a sample. Colony forming units are used as a measure of the number of micro-organisms present in or on surface of a sample.

9.What is Bioburden testing?

Bioburden testing is performed to determine the total number of aerobic viable microorganisms in or on a medical device, container or component after completion of all in-process steps prior to sterilization.

10. What is Enriched media?

These media support the growth of wide variety of microorganisms and doesn't inhibit the growth of microorganisms. 

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Questions for Qc Interview: Part 2

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

Hydrophilic-lipohilic 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.

11.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)

12.What is Viscosity?

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

13.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).

14.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.

15. What is Reference standard?

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.

16.Thin layer chromatography (TLC)

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

17.What is predictable dissolution?

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

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Questions for Qc Interview: Part 1

 1.What is Out of specification (OOS)?

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.

2.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.

3.What is Bioassay?

is an analytical method to determine the concentration or potency of a substance by its effect on living cells or tissues.

4.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.

5.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.

6.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.

7.What is TOC?

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.

8.How does high performance liquid chromatography (HPLC) work?

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.

9. 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.

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Questions for QA Interview: Part 4

 31.What are the sampling techniques used in the cleaning validation?

Swab sampling: Areas which are reasonably accessible & hardest to clean can be evaluated, leading to level of contamination or residue per gives surface area.

Rinse sampling: Large areas or parts of equipments which could not be swabbed should be rinse sampled or directly extracted by solvent. Tubes, nozzles, pipes or containers with surface those are not reasonably accessible for direct surface sampling have to be rinsed with solvent.

In addition, inaccessible areas of equipment that cannot be routinely disassembled can be evaluated.

32.What is OOT and define?

"OOT" stands for Out Of Trend. It means any test results obtained for a particular batch that is markedly different the results of the batches in a series obtained using a same validated method.

33.What is calibration?

The demonstration that a particular instrument or device produces results within specified limits by comparison with results produced by a reference or traceable standard over an appropriate range of measurements.

34.What is the micron size of HEPA filter?

The micron size of HEPA filter is 0.3µm

35.What is the abbreviation of CAS Number?

CAS Number: Chemical Abstract Service Number

36.What is in-process control?

Monitoring the manufacturing process at different stages is called in-process control. In-process control of the process provides an acceptable and achievable level of built in quality assurance for the product. This is possible through appropriate GMP during all manufacturing steps.

37.What do you mean by market complaint?

Any communication, written or verbal, received regarding the quality, packing directly from any traders or product manufacturer and marketing staff or any other such complaints shall be considered as a Market Complaint

38.Describe the categories of the market complaints?

Market complaints are categorized into three types

and are as follows:

Critical: Complaints related to suspected contamination, adulteration and mislabeling.

Major: Complaints related to the product not meeting its pre-determined critical specifications and damage to primary packaging.

Minor: Complaints related to the product not meeting non-critical quality attributes, or damage to secondary packaging or shortages etc.

39. What do you mean by re-validation?

A repeat of the process validation to provide an assurance that changes in the process/equipments introduced in accordance with change control procedures do not adversely affect process characteristics & product quality.

40. What is the QMS?

It is the quality management system to direct and control an organization with regard to quality.

Questions for QA Interview: Part 3

 21. What are the different types of cleanings?

There are three types of cleanings:

Batch to Batch cleaning

Periodically cleaning

Product change over cleaning

Campaign length cleaning (As like Product Change over cleaning).

22.What is expiry date & re-test date?

Expiry date: The date place on the container / labels of an API designated the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions and after which it should not be used.

Re-test date: The date when a material should be re-examined to ensure that it is still suitable for use.

The period of time during which the drug substance is expected to remain within its specifications and therefore, can be used in the manufacturing of the drug product, provided that drug substance has been stored under the defined conditions.

23. What is change control and its types?

Change control is a system that control change by

i. Identifying ownership of the change

ii. Allowing for review and approval of the change.

iii. Preventing changes that could adversely affect product quality or conflict with registration or regulatory requirement.

iv. Providing an assessment of change and monitors the impact of change.

Minor: Are those that are unlikely to have any detectable impact on the quality attributes of the product.

Major: Are those that are likely to have a significant impact on the yield and quality attributes of the product.

The type of reasons for change control: Regulatory requirement

GMP implementation/enhancement

Quality improvement

Capacity enhancement

- Introduction of new product in existing facility

Cost reduction

Automation

- Aging of facility

To manage the unavoidable situation

- Market requirement

24. What is deviation & its types?

Deviation is departure from the approved instructions /established standards. There are two types of deviation and given below:

Controlled/planned deviation: Any deviation from documented procedure opted deliberately for temporary period to manage unavoidable situation or improving the performance of the operations, without affecting the quality & yield of drug substance and safety of the operations shall be termed as controlled/planned deviation. Uncontrolled/unplanned deviation: Any deviation occurred in unplanned or uncontrolled manner such as system failure or equipment breakdown or manual error shall be termed as uncontrolled / unplanned deviation.

Category of deviations: Critical, Major and Minor.

25.What is quarantine?

The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.

26.What is definition of critical process parameters?

A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.

27.What is CAPA?

CAPA is the Corrective Action & Preventive Action.

Corrective Action: Action taken to eliminate the

causes of an existing non-conformity, defect or other undesirable situation to prevent recurrence. [Actions taken after the occurrence of a defect or problem to stop the same from recurrence]. Preventive Action: Action taken to eliminate the causes of potential non-conformity, defect or other undesirable situation to prevent occurrence. [Actions initiated before the occurrence of a defect or problem to prevent the same occurrence].

28.What is HVAC?

The HVAC is designed to circulate the air in the area after passing it over cooling & heating coils to maintain the required environmental conditions & passing it through the series of filters to maintain desired cleanliness level in the area. The air in-take and out-take of the system is designed to maintain certain degree of pressure gradient in the area as per requirements.

29.How many guidelines are present in Q & what are those, describe in detail?

In Quality (Q), total 14 guidelines are present. Those

are as follows:

Q1 - Stability

Q2 - Analytical Method validation

Q3 - Impurities

Q4 - Pharmacopoeia

Q5 - Biotechnological quality

Q6 - Specification

Q7 - Good Manufacturing Practice (GMP)

Q8 - Pharmaceutical Development

Q9 - Quality Risk Management

Q10 - Pharmaceutical Quality System

Q11 - Development and Manufacture of Drug

Substances (Chemical Entities and Biotechnological/

Biological Entities)

Q12 - Pharmaceutical Product Lifecycle Management

Q13 - Continuous Manufacturing of Drug Substances

and Drug Products

Q14 - Analytical Procedure Development and Revision

30. What is OOS?

Out of Specification (OOS) results are those results, generated during testing that do not comply with the relevant specification or standards or with the defined acceptance criteria

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Questions for QA Interview: Part 2

 11. Definition of process validation and types of process validation?

Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate / API meeting its pre-determined specifications and quality attributes.

Process validation is three types:

1. Prospective process validation

2. Concurrent process validation

3. Retrospective process validation

12.What is the prospective, concurrent and retrospective validation?

Prospective process validation: Prospective Process validation shall be carried out for all the intermediate stages and Active Pharmaceutical Ingredients prior to the distribution of a new product. [ICH: GMP, EU: GMP, PIC/S: GMP]

Concurrent process validation: Any validated process undergoes a change either for the equipment or addition, deletion of a critical manufacturing process step, scale up or scale down, the same needs to be validated concurrently. This validation is carried out only after a change of an existing validated process to support the change made or involve with the requirements.

Retrospective process validation: Validation of a process for a product already in distribution based upon accumulated production, testing and control data. [ICH: GMP, EU: GMP, PIC/S: GMP]

13.What do you mean by validation protocol and its contents of process validation?

A written plan stating, how validation will be conducted and defining acceptance criteria e.g: The protocol for manufacturing process identifies process equipments, critical process parameters, and / or operating range, product characteristics, sampling, test data to be collected, number of validations runs and acceptance test results.

Contents:

Protocol Approval

Table of contents

Objective

Scope

Responsibility

Accountability Validation team

Brief manufacturing process (Description, Flow chart, Reaction scheme)

Selection of batches

List of equipments used in the manufacturing

process

List of raw materials used in the manufacturing

process

Critical operations with justification

In-process controls with acceptance criteria

Sampling & testing plan with frequency

Stability programm

Data to be complied

Acceptance criteria

Intermediate & final product quality & yield

Stability specification

Document review

Training record

Conclusion

Revalidation criteria

14.What is the definition of the procedure?

A documented description of the operation to be performed, the precautions to be taken, and measures to be applied directly or indirectly related to the manufacture of an intermediate / API (Reference: ICH Q7A).

15.What is the master document?

Master document is a formally authorized source document relating to specifications, and / or manufacturing/analytical methods, which is protected from un-authorized access or amendment.

Documents required describing the quality system requirements in the organization.

Documents required describing the process or product characteristics.

Documents required by various regulatory agencies as part of compliance to GMP requirements.

Documents required for legal/regulatory supports of the organization to meet the local regulations.

Any other documents required by government/ regulatory agency.

16.What are the types of different training programs?

1. Induction training

2. Job oriented training

3. cGMP training

4. On-going training

17. Write the names of the different countries regulatory body.

United Status of America - USFDA (United state Food and Drug Administration)

Australia - TGA (Therapeutic Goods Administration)

United Kingdom - MHRA (Medicines & Health care

products Regulatory Agency) South Africa - MCC (Medicine Control Council)

Brazil - ANVISA (Brazilian Health Surveillance Agency or National Sanitary Surveillance Agency)

Hungary - PIC/S (Pharmaceutical Inspection

Convention or Pharmaceutical Inspection Cooperation Scheme)

Germany - NIP (National Institute of Pharmacy)

Bangladesh - DGDA

Philippines - BFAD (Beaureu of Food & Drug)

18. What is the abbreviation of MSDS and how many contents are mentioned & what are those?

MSDS means Material Safety Data Sheet and it contains 16 contents. Those are given below:

1. Product Identification

2. Composition/Information on Ingredients

3. Hazards identification

4. First Aid measures

5. Firefighting measures

6. Accidental release measures

7. Handling & storage

8. Exposure controls / Personal protection

9. Physical & Chemical properties

10.Stability & Reactivity

11. Toxicological information

12. Ecological information 13.Disposal consideration

14.Transport information

15.Regulatory information

16.Other information

19.What is the different types of Qualifications and write its flow?

Qualifications are as follows: Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.

URS/DS-FAT-SAT-DQ-IQ-OQ-PQ

 20. What is audit/inspection and Why quality audit? Write different types of audits/inspection?

A planned and systematic examination and check of a system, procedure or operation in order to monitor compliance with and the effectiveness of established standards and to allow for improvement and corrective measures where required.

Quality audit because of:

To assess the effectiveness of the quality

management system

Assessing conformance

Investigating problems

Continual improvement of performance

Assessing for Registration

Reducing cost of operation

Legal requirement

Types:

1. Study/test based inspection

2. Facility based inspection

3. Process based inspection

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Questions for QA Interview: Part 1

1. What do you mean by "Quality Assurance"?

The sum total of the organized arrangements made with the objects of ensuring that all Products are of the quality required for their intended use and the quality systems are maintained.

2.What is the definition of SOP?

SOPs are detailed written instructions for the operations routinely performed in the course of any activities associated with pharmaceutical manufacturing.

A written authorized procedure which gives instructions for performing operations not necessarily specific to a given product / material, but of a more general nature the equipments preventive maintenance and cleaning; recall of products; purchasing; cleaning of premises and environmental control; sampling and inspection etc.

3.What are the contents of the SOP?

Objective/Purpose, Scope, Responsibility, Accountability, Procedure, List of formats/Annexure, Abbreviations, Reference, Revision History.

4.What is the clean room?

Clean rooms are defined as especially constructed, environmentally controlled enclosed spaces with respect to airborne particulates, temperature, humidity, air pressure, air flow patterns, air motion, vibration, noise, viable (living organisms) and lighting.

Particulate control includes:

Particulate & microbial contamination Particulate concentration & dispersion

5.What are the classifications of clean rooms?

Generally clean rooms are classified in to the following types as per different guidelines: Schedule M: Grade A, Grade B, Grade C, Grade D

USFDA (US 209E): Class 1, Class 10, Class 100, Class 1000, Class 10000, Class 100,000 WHO 2002: Grade A, Grade B, Grade C, Grade D EU GMP: Grade A, Grade B, Grade C, Grade D ISO 14644-1: ISO-3, ISO-4, ISO-5, ISO-6, ISO-7, ISO-8, ISO-9 Australia (AS 1386): 0.035, 0.35, 3.5, 35, 350, 3500 Germany (VDI 2083): 1, 2, 3, 4, 5, 6

6.What is the difference between GMP & cGMP?

GMP: GMP is the part of Quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

GMP are aimed primarily at diminishing the risks

inherent in any pharmaceutical production.

Such risk  are essentially of two types:

Cross-contamination (in particular of unexpected

contamination)

Mix-ups (confusion)

CGMP: Current Good Manufacturing Practices. This means any procedure / system adopted by the manufacturer which proves to be necessary and important for identity, strength and purity of a product.

7.What is the difference between Qualification and Validation?

Qualification is equipment / instrument oriented but validation is process oriented

8. What is the definition of Validation?

Validation is the documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting predetermined acceptance criteria

9. What are the types of validation?

Process validation, Analytical method validation, cleaning validation, facility validation, Utility validation & software validation.

10.What is the definition of Qualification?

Qualification is the action of proving and documenting that any equipment or ancillary systems are properly installed, work correctly, actually show the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.

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