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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 phar

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

Temperature: 25±2˚C & Relative Humidity: 50±5%

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.

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

55. What are specifications of Purified water as per any phar




 

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