Stability (ICH Q1A) Quiz 2

August 11, 2023August 11, 2023 by Pharmaguidanaces Channel

Stability (ICH) Quiz 2

Stability (ICH) Quiz 2

ICH Stability Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II. Furthermore, the revised document takes into account the requirements for stability testing in Climatic Zones III and IV in order to minimize the different storage conditions for submission of a global dossier.

1 / 10

Question: 1: How long should the long-term stability testing cover for at least three primary batches?

6 months

9 months

12 months

24 months

2 / 10

Question: 2: What temperature and relative humidity are used for accelerated storage condition testing?

25°C ± 2°C/60% RH ± 5% RH

30°C ± 2°C/65% RH ± 5% RH

40°C ± 2°C/75% RH ± 5% RH

20°C ± 2°C/50% RH ± 5% RH

3 / 10

Question: 3: Which intermediate storage condition is applicable when long-term studies are conducted at 30°C ± 2°C/65% RH ± 5% RH?

No intermediate condition is applicable

20°C ± 2°C/50% RH ± 5% RH

30°C ± 2°C/65% RH ± 5% RH

40°C ± 2°C/75% RH ± 5% RH

4 / 10

Question: 4: How is "significant change" for a drug substance defined?

Changes in its packaging materials

Failure to meet its specification

Variations in its taste and odor

Differences in its color and texture

5 / 10

Question: 5: What storage condition is recommended for drug substances intended for storage in a refrigerator?

0°C ± 2°C

5°C ± 3°C

10°C ± 5°C

20°C ± 2°C

6 / 10

Question: 6: What temperature is considered for long-term storage of drug substances intended for storage in a freezer?

-5°C ± 3°C

-10°C ± 2°C

-20°C ± 5°C

-30°C ± 2°C

7 / 10

Question: 7: How are drug substances intended for storage below -20°C treated?

With an accelerated storage condition

On a case-by-case basis

At room temperature

With intermediate storage conditions

8 / 10

Question: 8: What is the purpose of making a stability commitment post approval?

To extend the re-test period

To establish a new drug substance

To discontinue the stability studies

To firmly establish the re-test period

9 / 10

Question: 9: Under what condition is a post approval commitment considered unnecessary?

When long term stability data on primary batches cover the proposed re-test period

When the submission lacks stability data

When accelerated stability studies are conducted

When the submission includes data on fewer than three production batches

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Question 10: How the degree of variability of individual batches is related to the confidence in future production batches?

Variability decreases confidence

Variability increases confidence

Variability has no impact on confidence

Variability is unrelated to confidence

Your score is

The average score is 51%

Post Views: 47

Categories QA & QC, Quality Assurance, Quiz

Stability (ICH Q1A) Quiz 1

Stability (ICH Q1A) Quiz 3

1 / 6

Question 1 : Any change in the documents shall be governed by Change control procedure?

True

False

2 / 6

Question 2: Who shall raise the change control?

Any person

Stores

Administration

3 / 6

Question 3 : What role does change control play in relation to regulatory compliance?

It is optional and not related to compliance.

It helps companies evade regulatory scrutiny.

It is essential for ensuring compliance with regulatory requirements.

It is primarily a marketing tool.

4 / 6

Question 4 : What is the first step in the change control process?

Implementation

Evaluation

Planning

Closure

5 / 6

Question 5: What is the primary purpose of change control in the pharmaceutical industry?

To increase production efficiency

To reduce operating costs

To maintain and improve product quality

To expedite product development

6 / 6

Question 6 : Which regulatory requirement mandates the implementation of change control in the pharmaceutical industry?

Good Laboratory Practices (GLP)

Good Distribution Practices (GDP)

Good Manufacturing Practices (GMP)

Good Clinical Practices (GCP)

Your score is

The average score is 74%

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