Pharmaceutical Interview Questions 4

Pharmaceutical Interview Questions 4 contains questions about change control and its types, deviation & its types, heat exchange equipment, ICH, instrument & equipment, validation & testing, listed below

31. What are deviation & its types?
32. What are change control and its types?
33. Definitions

Batch number,
Batch contamination
Cross-contamination
Quarantine
Critical process parameters
Mother liquor,
OOSTheoretical yield
Expected yield
CAPA
Installation Qualification (IQ)
Operating Qualification (OQ)
Performance Qualification (PQ)

34. What is the ICH? Write its aim/purpose and names of the different parties & different regions?
35. Difference between validation &...
36. ....

31. What are 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.

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32. What are change control and its types?

Change control is a system that control change by

Identifying ownership of the change
Allowing for review and approval of the change.
Preventing changes that could adversely affect product quality or conflict with registration or regulatory requirement.
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

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33. Definitions

Batch number, Batch contamination

Cross-contamination

Quarantine

Critical process parameters

Mother liquor,

OOSTheoretical yield

Expected yield

CAPA

Installation Qualification (IQ)

Operating Qualification (OQ)

Performance Qualification (PQ)

Batch Number:

A unique combination of numbers, letters, and/or symbols which identifies a batch (or lot) and from which the production and distribution history can be determined

Batch:

A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. Batch size may be defined either by a fixed quantity or the amount produced in a fixed time interval.

Contamination:

The undesired introduction of impurities of a chemical or Microbiological nature, or of foreign matter, in to or onto a raw material, intermediate, or API during production, sampling, packaging or repackaging, storage or transport.

Cross-contamination:

Contamination of a material or of a product with another material or product.

Quarantine:

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

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.

Mother liquor:

The residual liquid which remains after the crystallization or isolation processes. Mother liquor may contain un-reacted materials, intermediates, levels of the API and/or impurities. It may be used for further processing.

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.

Theoretical yield:

The quantity that would be produced at any appropriate phase of production, based upon the quantity of material to be used, in the absence of any loss or error in actual production.

Expected yield:

The quantity of material or the percentage of theoretical yield anticipated at any appropriate phase of production based on previous laboratory, pilot scale, or manufacturing data.

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].

Installation Qualification (IQ):

Establishing high degree of confidence that the equipment as installed is consistent with manufacture’s requirements and specifications.

Operating Qualification (OQ):

Establishing a high degree of confidence that the equipment as installed is able to consistently operate within established limits and tolerances.

Performance Qualification (PQ):

Establishing a high degree of confidence, with appropriate testing that the equipment, under normal operating conditions, will consistently produce a quality product.

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34. What is the ICH? Write its aim/purpose and names of the different parties & different regions?

ICH means

“International conference on harmonization”.

Aim/Purpose:

“Ensure good quality, safety and effective medicines are developed and registered in the most effective manner, through harmonization of technical requirements”

Different Parties:

1. European commission – European Union (EMEA)

2. European Federation of Pharmaceutical Industries & Association (EFPIA)

3. Minister of health, Labor & Welfare, Japan (MHLW)

4. Japan Pharmaceutical Manufacturers Association (JPMA)

5. US Food & drugs Administration (FDA)

6. Pharmaceutical Research & Manufactures of America (PhRMA)

Different regions:

1. European Union (EMEA)

2. United states of America (USFDA)

3. Japan (MHLW)

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35. Difference between validation & testing?

Both are not same. Testing is defined as the identification of errors (difference between expected & actual results) in a system.

Validation is defined as documented evidence that a system performance as expected. Validation includes testing but it is more – for instance, checking the documents for completeness & correctness.