Cipla Senior Executive Quality Control Interview Questions and Answers for Experienced

Out of specification flow occurs when a product or process does not meet the required standards or specifications.

• Occurs when a product or process deviates from the specified requirements

• Can result in defects, rework, or product recalls

• Requires investigation to identify root cause and corrective actions

• May involve adjusting processes or making changes to the product design

• Can impact product quality, customer satisfacti

System suitability criteria are established parameters to ensure that an analytical method is suitable for its intended use.

• System suitability criteria are typically based on precision, accuracy, linearity, and robustness of the analytical method.

• These criteria are set by regulatory agencies or internal quality control standards.

• Examples of system suitability criteria include %RSD for peak area, retention time, and res...read more

Investigation guidelines outline the steps to follow when conducting an investigation.

• Clearly define the scope and objectives of the investigation

• Gather relevant evidence and information

• Interview witnesses and involved parties

• Analyze the collected data to identify root causes

• Document findings and recommendations

• Follow up on corrective actions taken

Bacteria are single-celled prokaryotic organisms, while fungi are eukaryotic organisms that can be single-celled or multicellular.

• Bacteria are prokaryotic, meaning they lack a true nucleus and membrane-bound organelles, while fungi are eukaryotic with a true nucleus and organelles.

• Bacteria reproduce asexually through binary fission, while fungi reproduce sexually or asexually through spores.

• Bacteria are typically small...read more

Dungi is a type of fungus that grows on decaying organic matter, while mold is a type of fungus that grows on various surfaces.

• Dungi typically grows on soil, wood, or plant material, while mold can grow on walls, food, or other surfaces.

• Dungi is often associated with decomposition processes, while mold is commonly found in damp or humid environments.

• Dungi can be beneficial in breaking down organic matter, while mold ca...read more

Fungi and mold are types of microorganisms that can grow in various environments.

• Fungi are eukaryotic organisms that include yeasts, molds, and mushrooms

• Mold is a type of fungus that grows in the form of multicellular filaments called hyphae

• Examples of fungi include Aspergillus, Candida, and Penicillium

• Examples of mold include Alternaria, Cladosporium, and Stachybotrys

The number of weights in a balance calibration weight box varies depending on the specific box.

• The number of weights can range from a few to several dozen, depending on the precision required for calibration.

• Common calibration weight boxes may contain weights ranging from 1 gram to 500 grams.

• Some calibration weight boxes may also include additional weights for fine adjustments.

• The exact number of weights in a box can b...read more

Weights can be differentiated by their units of measurement (mg, g), and by their numerical value (2, 20, 200).

• Differentiate by units of measurement (mg, g)

• Differentiate by numerical value (2, 20, 200)

Theoretical plates are considered as system suit because they help in separating and purifying components in a system.

• Theoretical plates are used in chromatography to separate and purify components in a mixture.

• They are considered as system suit because they help in achieving a high degree of separation efficiency.

• The more theoretical plates a system has, the better it is at separating components.

• Theoretical plates are...read more

Water content can be calculated by subtracting the weight of the dry sample from the weight of the sample after drying.

• Water content = (Weight of wet sample - Weight of dry sample) / Weight of dry sample

• Dry the sample in an oven at a specific temperature until it reaches a constant weight

• Weigh the sample before and after drying to determine the weight loss

• Water content is usually expressed as a percentage

Similarity factor (recovery factor) is calculated to assess the similarity between two dissolution profiles.

• Similarity factor is a measure of the closeness of two dissolution profiles.

• It is calculated using the mean and standard deviation of the percent dissolved values at each time point.

• The formula for similarity factor is SF = 50 * log((1 + (1/n) * Σ(|R-T|/R)) / (1 + (1/n) * Σ(|R-T|/T))), where R is the reference pr...read more