10+ TekisHub Consulting Services Interview Questions and Answers

cGMP stands for current Good Manufacturing Practice, a set of regulations ensuring quality and consistency in the production of pharmaceuticals.

• cGMP is a regulatory standard enforced by the FDA to ensure the quality, safety, and efficacy of pharmaceutical products.

• It covers various aspects of manufacturing such as facility design, equipment maintenance, personnel training, and record-keeping.

• Adherence to cGMP guidelines is crucial for pharmaceutical companies to obtain regula...read more

Saturation solubility refers to the maximum amount of solute that can dissolve in a solvent at a given temperature.

• Saturation solubility is important in pharmaceutical research to determine the maximum concentration of a drug that can be dissolved in a specific solvent.

• It is typically expressed in terms of milligrams of solute per milliliter of solvent.

• The World Health Organization (WHO) may provide guidelines or recommendations on saturation solubility for certain drugs or c...read more

Validation ensures the right product is being built, while verification ensures the product is being built right.

• Validation confirms that the product meets the customer's requirements and needs.

• Verification ensures that the product is being built according to the specifications and design.

• Validation is about checking if we are building the right product, while verification is about checking if we are building the product right.

• Examples: Validating that a software application ...read more

CMC stands for Chemistry, Manufacturing, and Controls. It refers to the regulatory requirements for the development and manufacturing of pharmaceutical products.

• CMC includes information on the drug substance, drug product, and manufacturing process.

• Limits in CMC refer to the specifications and controls set for raw materials, intermediates, and finished products.

• Examples of CMC limits include purity, potency, impurities, and stability criteria.

OOT and OOS investigations are conducted to determine the root cause of results that are out of specification or out of trend.

• Identify the OOT or OOS result

• Isolate the sample for further testing

• Investigate potential causes such as equipment malfunction or human error

• Document findings and corrective actions taken

• Review and approve investigation report

Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle.

• Ensuring data is accurate and reliable

• Preventing unauthorized access or changes to data

• Maintaining consistency of data across systems

• Implementing data validation processes

• Regularly auditing data to ensure integrity

I handle incidents by remaining calm, assessing the situation, taking appropriate action, and following up to prevent future occurrences.

• Remain calm and composed during the incident

• Assess the situation to determine the severity and necessary actions

• Take appropriate steps to address the incident effectively

• Follow up to analyze the root cause and implement preventive measures

• Communicate effectively with team members and stakeholders

Sink condition refers to a state in which the rate of drug absorption is faster than the rate of drug elimination.

• Sink condition occurs when the drug is rapidly absorbed into the bloodstream but is also quickly eliminated from the body.

• In sink condition, the drug concentration in the body remains low due to fast elimination, leading to incomplete absorption.

• Sink condition is important to consider in pharmacokinetic studies to ensure accurate assessment of drug absorption and ...read more

RS method development involves creating and optimizing analytical methods for the analysis of raw materials and finished products.

• RS method development includes selecting appropriate analytical techniques based on the properties of the sample.

• It also involves optimizing parameters such as sample preparation, chromatographic conditions, and detection methods.

• Examples of RS method development include developing HPLC methods for quantifying active ingredients in pharmaceutical f...read more

Deviation management involves identifying, documenting, investigating, and resolving any deviations from standard procedures or specifications.

• Deviation management is a process used to address any deviations from established procedures or specifications.

• It involves documenting the deviation, investigating the root cause, and implementing corrective actions to prevent recurrence.

• Examples of deviations include equipment malfunctions, procedural errors, or unexpected results in ...read more

Surfactants are classified into four main types: anionic, cationic, nonionic, and amphoteric, each with specific limits and applications.

• Anionic surfactants have a negatively charged head group and include sulfates, sulfonates, and carboxylates.

• Cationic surfactants have a positively charged head group and are often used as fabric softeners or antimicrobial agents.

• Nonionic surfactants have no charge and are commonly used in personal care products like shampoos and lotions.

• Amph...read more

Dissolution development involves studying how a drug dissolves in a specific medium over time to determine its release profile.

• Dissolution testing is crucial for assessing the bioavailability of a drug

• Factors affecting dissolution include pH, temperature, agitation speed, and medium composition

• Different dissolution methods include paddle method, basket method, and flow-through cell method

SOP (Standard Operating Procedure) outlines the steps and guidelines for performing a specific task or process.

• SOPs detail step-by-step instructions

• Include safety precautions and quality control measures

• Should be clear, concise, and easy to follow

• May include diagrams, flowcharts, or checklists

• Regularly reviewed and updated to reflect current best practices