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Interview Questions and Answers for Pharmaceutical (Part 11)

May 14, 2025

Interview Questions and Answers for Pharmaceutical Part 11

Que 1: What is OOT and define?

Answer: “OOT” stands for Out of Trend. It means any test results obtained for a particular batch that is markedly different the results of the batches in a series obtained using a same
validated method.

Que 2: What is calibration?

Answer: 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.

Que 3: What is the micron size of HEPA filter?

Answer: The micron size of HEPA filter is 0.3μm

Que 4: What is the abbreviation of CAS Number?

Answer: CAS Number: Chemical Abstract Service Number

Que 5: What is in-process control?

Answer: Monitoring the manufacturing process at different stages is called in-process control. In process control of the process provides an acceptable and achievable level of built in quality assurance for the product. This is possible through appropriate GMP during all
manufacturing steps.

Que 6: What do you mean by market complaint?

Answer: Any communication, written or verbal, received regarding the quality, packing directly from any traders or product manufacturer and marketing staff or any other such
complaints shall be considered as a Market Complaint.

Que 7: Describe the categories of the market complaints?

Answer: Market complaints are categorized into three types and are as follows:

Minor: Complaints related to the product not meeting non-critical quality attributes, or damage to secondary packaging or shortages etc.

Major: Complaints related to the product not meeting its pre-determined critical specifications and damage to primary packaging.

Critical: Complaints related to suspected contamination, adulteration and mislabeling.

Que 8: What do you mean by re-validation?

Answer: A repeat of the process validation to provide an assurance that changes in the process/equipment’s introduced in accordance with change control procedures do not adversely affect process characteristics & product quality.

Que 9: What is the QMS?

Answer: It is the quality management system to direct and control an organization regarding quality.

Que 10: What is retention sample & why retention sample is preserved?

Answer: A part of the sample which is representative of the released batch of a finished product preserved beyond its shelf life. It is preserved for future reference / reanalysis in cases of market complaints or development work or any other clarification about the released batch.