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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