Q.1 Define Quality assurance?
Ans: Quality Assurance is a broad range of concepts that contains all the matters that individually or collectively affect the Quality of a product. QA mainly concentrated on planning and documenting the procedures to assure Quality.
Q.2 What is Documentation?
Ans: Documentation is all types of written procedures, records, and instructions, Quality control test records with procedures involved in all manufacturing activities of drug products.
Q.3 What are In process checks?
Ans: In-process checks are checks carried out during an activity to monitor and, where necessary, to adapt the process to ensure that the product conforms to its specification.
Q.4 During In-process Checks, what will need to be checked/Recorded?
Ans: Recording of various parameters like; 1) Environmental Monitoring 2) Measured values obtained from the process equipment (ex: temperature, RPM.) 3) Measured values obtained from persons (ex: timings, entries.) 4) Process attributes (Ex: weight, hardness, stability.
Q.5 What precautions shall be taken while collecting in-process samples?
Ans: While collecting in-process samples, protect the sample from contamination while sampling (Do not collect samples with bare hands). Use gloves while sampling.
Q.6 What are the factors which influence tablet hardness?
Ans: 1. force applied for compression
2. Binder quantity (More binder quantity, more hardness)
3. Presence of moisture in granules.
Q.7 If the leak test falls during In-process checks, what needs to be done?
Ans: Immediately stop the packing process and check for:
1. Sealing temperature
2. Check knurling quality and change in printed foil.
3. Check & quarantine the isolated quantity of packed goods from the last leak test passed during in-process.
4. Collect random samples & do a retest.
5. Blisters from the leak test passed containers shall allow going further, and the rest must be de-blistered/ Defoil accordingly.
Q.8 What needs to be checked during AHU validation?
Ans: During AHU validation, the following tests shall be carried out:
1) Air velocity & number of air changes
2) Airflow pattern (visualization)
3) Differential pressure, temperature, and RH
4) Static condition area qualification
5) Dynamic condition qualification
6) Non-viable count
7) Microbial monitoring
8) Area recovery and power failure study
Quality Assurance Interview Questions Related to Documentation
Q.9 What Is a Change Control?
Ans: Change Control is a general term describing the process of managing how changes are introduced into a controlled System. Into validation, implies how changes to the validated system are made. Change control is needed to demonstrate to regulatory authorities that after system modifications, validated systems remain under Control after system changes.
Q.10 What Is SOP?
Ans: A Standard Operating Procedure (SOP) is a specific type of document that describes how to perform a particular task or operation in a step-by-step outline. To ensure that tasks are conducted consistently and appropriately, everybody in an organization must follow the same procedures.
Many organizations have a broad range of SOPs that illustrate how to execute various tasks. In many companies, technicians, and operators are trained in how to follow individual SOPs and their training record specifies the SOPs they are trained on and are authorized to use.
Q.11 Tell about the content of the SOP
Ans: 1. Objective or Purpose/Aim
2. Scope
3. Responsibility
4. Procedure
5. Precautions
6. Annexure
7. Abbreviations
8. Reference
9. Revisions History
Q.12 How do stability studies?
Ans: These are necessary for developing pharmaceutical products. The influence of environmental factors (e.g., light, humidity, temperature.) on active pharmaceutical ingredients (API) or pharmaceutical ingredients (API) may be evaluated.
Q.13 Expand BMR and BPR
Ans: BMR – Batch Manufacturing Record, prepared as a written file during the Manufacturing of a product by writing, and Recording Step by the step manufacturing process, and details about batch recorded here. For every BMR, BPR is to be held for further packing records. BPR depends on packaging operation.
Q.14 Difference between validation and calibration?
Ans: Validation provides written evidence to ensure that a particular method or operation continuously develops a product with predetermined requirements and quality credits. It is performed according to the validation protocol.
Calibration denotes that Equipment produces the values in specified limits by comparing the values produced by a standard. It Is done according to the calibration SOP.
Q.15 What is a Change Request?
Ans: Change Control is a general term that describes the process of managing the implementation of changes in a controlled system that is controlled by the change request. control system into validation means how changes are made to the validated system. Change Control is made to demonstrate to the Regulatory authority, the reason that the validated system remains under Control after the system change. Change Control systems are a favorite target of regulatory auditors because they vividly demonstrate an organization’s capability to Control systems.
Q.16 What is 21 CFR part 11?
Ans: 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.
Q.17 Tell any five countries with their regulatory authorities.
Ans: India Central Drugs Standard Control Organization (CDSCO) USA – United States Food and Drug Administration (USFDA) UK Medicines and Healthcare Products Regulatory Agency (MHRA) Japan- Ministry of Health Labour and Welfare (MHLW) Australia- Therapeutic Goods Administration (TGA).
Common IPQA Interview Questions
Q.18 What position of the oblong tablet to be placed in the hardness tester to know the hardness
Ans: It should be lengthwise because its breakage probability is more in this position.
Q.19 Why do we calibrate an instrument at a particular interval?
Ans: because it can be possible for instruments to drift out of accuracy after qualification. So it needs to requalify the instrument at a specific time interval.
Q.20 What checks shall be carried out during the calibration of the Disintegration Test apparatus?
Ans: 1. Strokes number per minute. It shall be a 29-32 cycle per minute.
2. Temperature by using probes and a standard thermometer. It shall be 37±1°C
3. Traveling distance by the basket. It shall be 53-57 mm.
Q.21 Why is positive pressure kept in the corridor, not in the process area?
Ans: The different pressure gradient is essential at different locations to avoid cross-contamination of a product through the air.
Q.22 Recommended storage condition for empty hard gelatin capsule
Ans: It should be 15-25°C and 35-5/% RH.
Q.23 What shall be the DT Temperature recommendation for dispersible tablet
Ans) 25±1°C (IP) and 15-25°C (BP)
Q.24 Difference between validation and calibration?
Ans: Validation provides written evidence to ensure that a particular method or operation reliably develops a product with predetermined requirements and quality credits. It is performed according to the validation protocol.
Calibration denotes that Equipment produces the values in specified limits by comparing the values produced by a standard. It Is done according to the calibration standard operating procedure.
Q.25 Tell the time required for long-term and accelerated stability testing.
Ans: long term study 12 months
Accelerated stability for six months.
Q.26 What is SISPQ?
Ans: Safety, integrity, strength, purity, and Quality.
Q.27 Which Fluorescence material is used in BIN Washing while PQ?
Ans: Riboflavin
Q.28 Which class of Area is Required for Tablets and Capsule Manufacturing?
Ans: Class D
Q.29 What is positive pressure?
Ans: The atmospheric pressure is higher than the immediate surrounding areas, usually measured in inches of water or Pascal.
Q.30 What is the schedule- M?
Ans: schedule- M is the Good Manufacturing Practices and its Requirements of premises of the plant, waste disposal, and Equipment.
GMP is divided into two separate parts:
GMP I for Factory premises
GMP II For plant and Equipment.
Q.31 What is the Deviation?
Ans: A deviation is an unexpected event that accrues during the ongoing operation/activity/Documentation/entries at any stage of receipt, storage and Manufacturing, analysis and distribution of drugs products/Intermediate/Raw materials/ packing materials. The deviation is to be reported as and when events occur and to be investigated for impact analysis.
Q.32 What is VMP?
Ans: VMP Means Validation master plant. It is about brief information about the Qualification, Validation, and calibration of Equipment, instruments, and system. VMP types documents providing information on the company’s Validation work program. Responsibility related to VMP should be stated.
Q33. What is Market Complains?
Ans: A complaint is any expression of dissatisfaction with a product or service marketed. Any written/ genuine verbal communication received directly from any customer, retailer, distributor, healthcare professional, regulatory agency, patient (Consumer), or field staff regarding the safety, identity, strength, purity, Quality, shortages, or any other such complaint shall be treated as a market complaint.
Q.34 What is a Product recall?:
Ans: Removal or correction of marketed products for reasons relating to deficiencies in Quality, safety, or efficacy, including labeling considered to violate the laws.
Q.35 Vendor Qualification?
Ans: New Vendor: Manufacturer identified by Formulation Development or purchase department as a manufacturer supplying a specific material from a specific manufacturing site.
Approved Vendor: Manufacturer of raw material, primal, and printed packaging material, approved by QA to supply specific material from a specific site, based on the cGMP.
Q.36 Cleaning Validations?
Ans: DEFINITION: Cleaning Validation is the documented evidence that an approved cleaning procedure will provide Equipment suitable for processing medicinal products.
Q.37 Annual product quality review (APQR):
Ans: Documented regular periodic or rolling quality reviews of all licensed medicinal products to verify the consistency of the existing manufacturing process to highlight any trends and to identify product and process improvements or weaknesses for licensed medicinal products the appropriateness of current specifications for both starting materials and finished products.
Q.38 What is the limit for “individual unknown Impurity” in API as per ICH Q2A?
Ans: The limit of the “Any individual unknown Impurity” is not more than 0.1%
Q.39 What are the class-1 solvents as per ICH Q3C?
Ans: Benzene – 2
Carbon tetrachloride -4ppm
1, 2 Dichloroethane – 5ppm
1, 1 Dichloroethene – 8ppm
1, 1, 1 -Trichloroethane-1500 ppm
Q.40 Different ICH guidelines
Ans:
Q.41 What is the specific gravity of Methylene chloride?
Ans: The specific gravity of Methylene chloride is 1.308 gm/ml
Q.42 Suppose the Area is class 100000, then what are the maximum light and sound levels as per guidelines?
Ans: light level: not less than 300 lux.
Sound level: it should not be more than 80 decibels.
Q.43 What is the instrument name, which is used for measuring vacuum during high vacuum distillation?
Ans: Macleod gauge
Q.44 Is the cGMP requirement only for personnel in Manufacturing?
Ans: No, this requirement is for every employee of the organization who must know relevant cGMP requirements in his/her Area.
Q.45 Why do we conduct the training?
Ans: It brings awareness and helps employees to become competent.
Q.46 India belongs to which Climate Zone?
Ans: India comes under Climate Zone III (Known as the Hot, dry Zone) and Zone IVb (known as Hot/Higher humidity)
Q.47 What is force degradation or stress testing:
Ans: Force degradation is also known as stress testing, and a drug is degraded Forcefully by applying artificial methods.
It helps to know about Impurities that develop during the storage of drug products in various environmental conditions. Forced degradation study depends upon the product and the type of dosage form. Solid, liquid, and injection have different procedures for the stress study.
Q.48 Explain Qualifications and their flow
Ans: Design Qualifications, installation Qualifications, Operational Qualifications, and Performance Qualifications. Flow=URS>> FAT>>SAT>>DQ>>IQ>>OQ>>PQ.
Q.49 What is a Critical Quality Attribute?
Ans: it is chemical, physical, biological, and microbiological characteristics that should be under limits and range to ensure the Quality of the products.
Q.50 What is OOS (Out of Specification)?
Ans: A result that falls outside established acceptance criteria established in official compendia and by company documentation.
OR
Out of specification is the comparison of one result versus predetermined specification criteria.
Example of OOS (Out of Specification):
The specification limit for the assay is 90.0-110.0 % w/w of the label claim.
For a selected batch, the result obtained is 85.2 % w/w – This result is out of the specification limit, which is often called OOS.
Q.51 What is OOT (Out of TREND)?
Ans: Results of a drug substance of a selected batch, which is within the specification limit but a similar result compared to other batches of a similar drug substance, falling outside the typical results of all compared batches.
Or
specification results may be within limits but show a significant change from the historical results.
Example of OOT (Out of TREND):
The result obtained 95.8 % w/w. Although the results are well within the specifications, we should always compare the result with the previous batch’s trend. If we found the typical value of the trend as 99.0 % w/w, then this batch result (95.8 % w/w) is named out of trend.
Quality Assurance Interview Questions related to the processing Area?
Q.52 What is relative humidity?
Ans: it is the ratio between the amount of water vapor in a particular air volume and at provided temperature. The maximum amount of water vapor that the air can possess.
Q.53 If the temperature or RH of the Area goes out of the limit, what action is to be taken?
Ans: immediately stop the line, and inform the responsible department to raise the maintenance requisition slip. Ensure that all the intermediate materials are correctly covered.
Q.54 How to stop cross-contamination in an area?
Ans: By ensuring to follow proper gowning procedure and material transfer procedure and controlled staffing movement in the Area, maintaining Differential pressure is also essential to controlled cross-contamination.
IPQA Pharma Interview Question:
Q.55 What is process validation?
Ans: As per EMA Definition process validation is “documented evidence that of a method, operated within established parameters, that can be performed effectively and reproducibly to provide a medicinal product meeting as per its predetermined specifications and quality attributes.”
USFDA Definition Process validation is “The evaluation of data and collection, from the process design stage throughout the production stage, to consistently delivering a quality product” based on established scientific evidence.
Q.56 Consistent with regulatory guidelines (USFDA), what are the stages of process validation?
Ans: Process validation involves a series of activities happening over the lifecycle of Drug products and processes. There are three stages for process validation activities.
Stage 1 — Process Design: The commercial manufacturing process is defined based on knowledge gained through development and scale-up activities.
Stage 2 — Process Qualification: During this stage, the method design is evaluated to determine if the method is capable of reproducible commercial manufacturing.
Stage 3 — Continued Process Verification: Ongoing assurance is gained during routine production that the method remains in a state of Control.
Q.57 Tell How many batches took for the process validation?
Ans: The EMA draft guideline states “a minimum of three consecutive batches,” with justification to be provided (there are some exceptions to the current statement).
The USFDA guidance states that the number or quantity of batches must be sufficient to supply statistical confidence in the method. It is a subtle but essential distinction in the approaches.
Q.58 Explain the strategy for process validation of solid dosage forms.
Ans: The use of different lots of raw materials should be included. i.e., active drug substance and major excipients.
- Batches should be run serial and on different days and shifts (the latter condition, if appropriate). Batches should be manufactured within the Equipment and facilities designated for eventual commercial production.
- Critical process variables should be set within their operating ranges and will not exceed their upper and lower control limits during process operation. Output responses should be within the finished product specifications.
- Failure to satisfy the wants of the Validation protocol regarding process input and output control should be subjected to process requalification.
Q.59 What is Validation Protocol?
Ans: A written plan of action stating how process validation will be conducted; it will specify who will conduct the various tasks and define testing parameters; sampling plans, testing methods, and specifications; will specify the product and its characteristics And Equipment to be used.
It must specify the number of batches and acceptance criteria to be used for validation studies; and who will sign/approve or Disapprove the conclusions derived from such a scientific study.
Q.60 What should be processed validation protocol content?
- General information
- Objective
- Background/Pr- validation Activities, Summary of development and tech transfer (from R&D or another Site) activities to justify in-process testing and controls; any Previous validations.
- List of Equipment and their qualification status
- Facilities qualification
- Process flow charts
- Manufacturing procedure narrative
- List of critical processing parameters and necessary excipients
Q.61 What should be the blend sample size in In-process validation studies?
Ans: It is a 1x – 3x dosage unit range on a case-to-case basis. As per USFDA guidance, sampling sizes are often increased from lx -10x with adequate scientific justification.
Q.62 How many sampling points should be considered for collecting blend samples According to USFDA guidance?
Ans: According to USFDA guidance, At least 10 sampling locations are to be considered.
In the case of connective blenders, At least 20 locations are recommended to validate adequately (ex: ribbon blender)
Q.63 What will be the reason for the inside location variance of blend data?
Ans: Inadequacy of blend mix, sampling error, or agglomeration
Q.64 What is the difference between EMA & US guidelines on process validation?
Ans: EMA US Definition “documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.”
Definition It is “The evaluation of data and collection, from the process design stage throughout the production stage, to consistently delivering a quality product based on established scientific evidence.” The EMA draft guideline states “a minimum of three consecutive batches,” with justification to be provided (there are some exceptions to the present statement).
The US FDA guidance states that the number of batches must be sufficient to supply statistical confidence in the method. The EMA draft encourages the use of product development activities but is less sanctioned on requirements. The USFDA guidance emphasizes documenting the event phase as a part of PV. The EMA guideline explicitly allows the utilization of CPV to exchange traditional validation efforts.
The US FDA approach does not place a high emphasis on CPV. It requires all three stages of process validation to be fully addressed, regardless of whether contemporary or traditional methods are utilized. The US FDA guidance considers Equipment and process design and equipment qualification as part of the overall process validation effort. The EMA guideline sees the process as independent from Equipment and facility. Currently, the EMA still relies on Annex-15 of the GMP guide for instruction on equipment qualification.
Q.65 During process validation, Why the hopper challenge study is performing?
Ans: Hopper challenge study was performed to evaluate the effect of vibrations during compression on blend uniformity, a hopper study shall be carried out.
Q.66 What are the critical process variables in the coating?
Ans: Pan RPM, inlet & exhaust temperature, spray rate, gun distance, and air pressure.
Q.67 Why may blend be a critical parameter in tablet manufacturing?
Ans: Less blending will result in non-uniform distribution of drugs and poor flow, whereas more blending will result in de-mixing leading to non-uniform distribution of drugs and an increase in disintegration time
Q.68 What is the mess size of the DT apparatus?
Ans: 1.8 to 2.2mm (#10)
Q.69 DT Apparatus Limits/ Tolerance Limits
Ans: Disintegration test apparatus Limits/ Tolerance Limits are as follows:
- Temp. of water bath/Actual observation / Tolerance limit 37-39°C
- Temp. in the beaker/ Actual observation L&R/ Tolerance limit 37±2°C
- No. of strokes/min./4times Actual observation L&R/ Limit 29-32
cycle./min. - Stroke heights/ Actual observation L&R/ Tolerance limit 55 ±2mm.
- Baskets lowermost position/ Actual observation L&R/ 25 mm.
- Sieve Integrity/ Actual observation L&R/ 2.0mm ±0.2mm
Q.70 What is recommended temperature for checking DT for dispersible tablets?
Ans: 25±1°C as per (IP) and 15 to 25°C as per (BP).
Q.71 Tell pass and fail criteria for DT?
Ans: Repeat the test on 12 additional tablets or units if 1 or 2 units failed to disintegrate. The goal is achieved if 16 out of 18 tablets/capsules disintegrate entirely.
Q.72 Weight variation limits for Tablets?
Ans:
Q.73 Weight Variation Limits for Capsules?
Ans:
