Que 1: What are the different types of cleanings?
Answer:There are three types of cleanings:
Product change over cleaning
Batch to Batch cleaning
Periodically cleaning
Que 2: What is expiry date & re-test date?
Answer:
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.
Que 3: What is deviation & its types?
Answer: Deviation is departure from the approved instructions /established standards. There are two types of deviation and given below:
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.
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.
Que 4: What is change control and its types?
Answer:
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.
Level 1 (Minor): Are those that are unlikely to have any detectable impact on
the quality attributes of the product.
Level 2 (Major): Are those that are likely to have a significant impact on the
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
Que 5: What is quarantine?
Answer: The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.
Que 6: What is definition of critical process parameters?
Answer: 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.
Que 7: What is OOS?
Answer: 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.
Que 8: What is CAPA?
Answer: 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].
Que 9: What is HVAC?
Answer: 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.
Que 10: What are the sampling techniques used in the cleaning validation?
Answer: 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 equipment’s 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.
You Can Also Read:
Interview Questions and Answers for Pharmaceutical (Part 1)
Interview Questions and Answers for Pharmaceutical (Part 2)
Interview Questions and Answers for Pharmaceutical (Part 3)
Interview Questions and Answers for Pharmaceutical (Part 4)
Interview Questions and Answers for Pharmaceutical (Part 5)
Interview Questions and Answers for Pharmaceutical (Part 6)
Interview Questions and Answers for Pharmaceutical (Part 7)
