Translate

Pharmaceutical Interview Questions 6 contains questions about calibration, dedicated and non-dedicated equipment, HACCP, OHSAS, Pharmaceutical Interview Questions, Purified water as per any pharmacopoeia, validation listed below

51. What is limit of Temperature and relative humidity in the pharma area?
52. What is the difference between dedicated and non-dedicated equipment’s?
53. Why three batches consider for the validation?
54. If one batch is failed during the validation, then what will you do for completion of validation?
55. What are specifications of Purified water as per any pharmacopoeia?
56. Write the different storage conditions as per any guidelines (specify the name of guideline)?
57. What is ISO 9001, ISO 14001, ISO 18001, and ISO 22001?
58. What is HACCP, OHSAS?
59. Why one liter of water is equivalent to one kilogram of water at room temperature?
60. What is calibration?
[ads id="ads1"]

51. What is limit of Temperature and relative humidity in the pharma area?

Temperature: 25±2˚C & Relative Humidity: 50±5%
[ads id="ads1"]

52. What is the difference between dedicated and non-dedicated equipment’s?

Dedicated equipment

It is used solely for the production of a single product or product line. Concerns over cross-contamination with other products are markedly reduced.
Dedicated equipment’s must be clearly identified with the restrictions of use in order to prevent potential errors during cleaning and preparation.

Non-dedicated equipment

Where same piece of equipment utilized for a range of products formulations. Prevent of cross-contamination between products becomes the main objective in the cleaning validation effort.
Clearly, cleaning non-dedicated equipment’s represents a more significant obstacle to overcome.
[ads id="ads1"]

53. Why three batches consider for the validation?

Because of First one is for information, Second one is for confirmation and Third one is for evidence.

54. If one batch is failed during the validation, then what will you do for completion of validation?

When a quality parameter fails with respect to the specification, a deviation report shall be raised and the investigation shall be conducted immediately for the identification of failure.
If the reason for failure is identified, one more consecutive batch shall be considered for the validation run by taking preventive actions to avoid those failures (If necessary revise the MPCR and BPCR).
If the reason is unidentified, another three consecutive batches shall be taken for validation
[ads id="ads1"]

55. What are specifications of Purified water as per any pharmacopoeia?


[ads id="ads1"]

56. Write the different storage conditions as per any guidelines (specify the name of guideline)?

The different storage conditions are given below as per USP:
Freezer: -25°C to -10°C
Cold: Any temperature not exceeding 8°C
Refrigerator: Between 2°C and 8°C
Cool: 8°C to 15°C
Room temperature: The temperature at prevailing working area.
CRT: 20°C to 25°C
Warm: 30°C to 40°C
Excessive heat: Above 40°C
[ads id="ads1"]

57. What is ISO 9001, ISO 14001, ISO 18001, and ISO 22001?

ISO 9001 : Quality Standard Management
ISO 14001 : Environmental Standard Management
ISO 18001 : Safety & Health Standard Management
ISO 22001 : Hazop Standard Management
[ads id="ads1"]

58. What is HACCP, OHSAS?

HACCP: Hazard Analysis Critical Control Point
OHSAS: Occupational Health & Safety Assessment Series

59. Why one liter of water is equivalent to one kilogram of water at room temperature?


Because of at normal room temperature is between 25°C and 35°C at plant operating condition and the variation in weight Vs. Liter of water is negligible compared to volume.
[ads id="ads1"]

60. What is calibration?

The demonstration that a particular instrument or device produces results within specified limits by comparison with results produced by a reference or traceable standard over an appropriate range of measurements
[ads id="ads1"]

Thanks for reading - Pharmaceutical Interview Questions 6
Naitik Patel
Industrial Guide

Share this blog with your friends from here 👇

Previous Post Next Post