Top 30 commonly Pharma Interview Question and Answer For Production:
1. What is change control?
Ans:- A process which ensure that change to procedure, materials, methods, equipment & software are properly documented, approved, validated and traceable.
Change control is raised by user department as per requirement and finally the change control is approved by QA. Change control can be raised through software or through manually.
After Final approval of change control the changes can be made in documents and change control can be closed after completion of required action plan which is mentioned in the Change control form. Change controls are of two types i.e Major change control and Minor change control.
2. What is Deviation and its Types?
Ans:-Deviation is an unexpected events that occurs during the on going operation.
OR
"Defined as a departure from an approved instruction or established standards".
Planned deviation:- It is defined as deviation which is preplanned and we know the outcome that it will not impact on product quality, safety, efficiency.
Unplanned deviation:- Any deviation occurred in unplanned manner due to system failure or equipment breakdown or manual error shall be termed as unplanned deviation.
3. What is contamination?
Ans:- In any product presence of a substance other than product manufacturing formula.
4. What is cross-contamenation?
Ans:- It is defined as contamination of one product to another product.
5. What is mix-up?
Ans:- Mix-us is Undesirable mixing of material, product/batch by unintentionally or accidentally.
6. What is SOP?
Ans:- A SOP is a certain type of document that describes in a step by step outline from how to perform a particular task or operation.
Everybody working in organization has to follow the instruction which are written in SOP and perform their activities accordingly.
7. What is Calibration?
Ans:- Demonstration that a particular measuring device produces result within specified limit by comparison with those produce by reference standard device over an appropriate range of measurements.
OR
"Calibration is a process by which an instrument which is used to measure or qualify the process against standard values".
8. What is Out of trend (OOT)?
Ans:- The data that represents abnormal pattern or behavior from normal pattern is called as OTT.
9.What is Out of specification (OOS)?
Ans:- When the results of the laboratory test show the product values to be outside the specifications or acceptance criteria, it is said to be Out-of-Specification or OOS.
10. What is validation?
Ans:- It is a documented evidence that any process, procedure or method actually and consistently leads to the expected result.
11. Define Good Manufacturing Practice (GMP) and current Good Manufacturing Practice (cGMP)?
Ans:-
Good Manufacturing Practice:-
A GMP is a system to ensure that products manufactured are consistently produced and controlled in accordance to sufficient quality standard.
Current Good Manufacturing Practice:-
A cGMP as regulations enforced by the USFDA to comply with letest standards and technologies to improve the process as well as facilities. We have to follow the current practices as there are the changes in regulations so always you have to follow the current practices so it is called current.
A cGMP as regulations enforced by the USFDA to comply with letest standards and technologies to improve the process as well as facilities. We have to follow the current practices as there are the changes in regulations so always you have to follow the current practices so it is called current.
12. What is Batch Manufacturing Record (BMR)?
Ans:- BMR is a type of Documentation that provides the history of a batch from the raw material dispensing stage to completion of the batch or lot which include Dispensing of raw material, Granulation, Blending Compression, Capsule Filling, Coating, Inspection and yield at different stages. It also includes the details of the activity performed by whom, checked by whom, verified by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch manufacturing or process activity.
13. What is Batch Packing Record (BPR)?
Ans:- BPR is a type of Documentation that provides the history of a batch from packaging material dispensing, Blister packing, Bottle packing, Jar packing, Dry syrup Filling, labeling, printing, Carton packing and shipper packing up to the final Dispatch of a Batch or Lot.
It also includes the details of the activity performed by whom, checked by whom, verified by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch packing or process activity.
14. What is Corrective action and preventive action?
Ans:- Corrective action:- An action taken to eliminate the cause of the existing deviation , incident or problem in order to prevent its recurrence (occurring again).
Preventive action:- An action taken to eliminate the cause of potential deviation, incident or problem in order to prevent its occurrence (an incident or event) is called preventive action.
15. What is Active Pharmaceutical Ingredients (API)?
Ans:- A substance or a bulk pharmaceutical chemical that is intended to furnish pharmacological activity or pharmacological action or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of the disease or to effect the structure or any function of the body of man or other animals.
16. What is Airlock?
Ans:- An enclosed space with two or more doors, which is interposed between two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered.
An airlock is designed for use either by people or for material, goods and/or equipment.
Mainly 3 Types of change room in pharma
1. Cascade type
2. Bubble type
3. Shrink type
17. What is Clean room?
Ans:- Clean room is defined as an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area.
18. What is Finished Product?
Ans:- A finished dosage form that has undergone completion of all stages of manufacturing processes including packaging processes in its final container with labelling and which is ready for sale or release to market for dispatched.
19. What will be happen if cGMP are not followed?
Ans:- Non-compliance to cGMP may lead to:
- Poor quality of product manufacturing / services.
- Batch failure occurs.
- Market complaints and product recalls.
- Company’s reputation affected.
- Business will be affected.
- Regulatory takes action.
- Injuries or accidents will happen.
- Equipment failures.
20. What is AHU?
Ans:- The air-handling unit serves to condition the air and provide the required air movement
within a facility.
21. What is batch number (or lot number)?
Ans:- A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and from which the production and distribution history can be determined.
22. What is Controlled Area?
Ans:- An area constructed and operated in such a way that some attempt is made to control the introduction of potential contaminant (an air supply approximating to grade D may be appropriate) and the consequences of accidental release of living organisms.
23. What is Computerised system?
Ans:- A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control.
24. What is Critical Process Parameters?
Ans:- Process parameters that must be controlled within established operating ranges to ensure that the finished product or intermediate will meet specifications for quality and purity.
25. What is High Efficiency Particulate Air Filter (HEPA)?
Ans:- HEPA is Retentive matrix designed to remove a defined percentage of particulate matter of a defined size.
26. What is Turbulent flow and Unidirectional airflow?
Ans:-
Turbulent flow:- Turbulent flow, or non-unidirectional airflow, is air distribution that is introduced into the controlled space and then mixes with room air by means of induction.
Unidirectional airflow:- Unidirectional airflow is a rectified airflow over the entire cross-sectional area of a clean zone with a steady velocity and approximately parallel streamlines (see also turbulent flow). (Modern standards no longer refer to laminar flow, but have adopted the term unidirectional airflow.)
27. What is Process Validation?
Ans:- The 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.
28. What is Qualification?
Ans:- Action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results. The meaning of the word “validation” is sometimes extended to incorporate the concept of qualification.
29. What is Shelf Life?
Ans:- The time period during which a drug product and/or drug substance is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label.
30. What is Data integrity?
Ans:- All data are complete, consistent, accurate through out the data lifecycle. Data integrity are works on the principal of "ALCOA".
A stand for Attributable
L stand for Legible
C stand for Contemporaneous
O stand for Original
A stand for Accurate.