10+ Ipqa Officer Interview Questions and Answers for Freshers

Tablets are solid dosage forms containing active pharmaceutical ingredients and excipients, compressed into a specific shape and size for oral administration.

• Tablets are one of the most common types of solid dosage forms used in pharmaceuticals.

• They can be classified based on their release mechanism (immediate release, extended release, etc.) or formulation (film-coated, chewable, effervescent, etc.).

• Weight variation limits for tablets are specified in pharmacopoeias like IP,...read more

Leak test is performed by subjecting the product to a specific pressure and observing for any pressure drop over a specified time period.

• Select appropriate equipment for the test

• Set the pressure and time parameters as per the product specifications

• Connect the product to the equipment and initiate the test

• Observe for any pressure drop during the test period

• Record the results and take necessary actions if the product fails the test

Observations can be classified as critical, major, or minor based on their impact on quality and compliance.

• Critical observations have a significant impact on product quality and regulatory compliance.

• Major observations have a moderate impact on product quality and regulatory compliance.

• Minor observations have a minimal impact on product quality and regulatory compliance.

• Observations can be related to equipment, processes, documentation, or personnel.

• Examples of critical obse...read more

Primary packing is the packaging that directly contains the product, while secondary packing is the packaging that contains the primary packaging.

• Primary packing is in direct contact with the product, while secondary packing is not.

• Primary packing protects the product from contamination, damage, and tampering, while secondary packing provides additional protection during transportation and storage.

• Examples of primary packing include blister packs, vials, and ampoules, while e...read more

IPQA stands for In-Process Quality Assurance. It is a quality control process that ensures products meet quality standards during production.

• IPQA involves monitoring and verifying the quality of products during the manufacturing process.

• It includes checking raw materials, equipment, and processes to ensure they meet quality standards.

• IPQA helps identify and correct any issues that may arise during production, preventing defects and ensuring consistent quality.

• Examples of IPQA...read more

Sterilization system is a process of eliminating or killing all forms of microbial life from a surface, equipment, or a medium.

• Sterilization can be achieved through various methods such as heat, radiation, chemicals, and filtration.

• Autoclaving is a common method of sterilization that uses high-pressure steam to kill microorganisms.

• Ethylene oxide gas is used for sterilizing heat-sensitive medical equipment.

• UV radiation is used for sterilizing surfaces and air in hospitals and ...read more

Quality assurance is the process of ensuring that products or services meet the desired level of quality.

• It involves creating and implementing quality control procedures

• It ensures that products or services meet customer expectations

• It involves continuous monitoring and improvement of processes

• Examples include conducting inspections, testing products, and analyzing data

• It is important for maintaining customer satisfaction and brand reputation

Validation is the process of ensuring that a product or service meets the requirements and specifications of the customer.

• Validation is done to ensure that the product or service meets the intended use and performs as expected.

• It involves testing and verifying the product or service against the requirements and specifications.

• Validation is important in industries such as pharmaceuticals, medical devices, and food and beverage.

• Examples of validation include equipment validatio...read more

Change control is a process to manage changes in a controlled and systematic manner.

• It involves documenting and reviewing proposed changes

• Assessing the impact of changes on quality, safety, and efficacy

• Implementing changes in a controlled manner

• Ensuring that changes are communicated to relevant stakeholders

• Examples include changes to manufacturing processes, equipment, or specifications

Line clearance procedure is a process followed in pharmaceutical manufacturing to ensure that equipment and areas are free from any previous product or contamination before starting a new production.

• Line clearance procedure is performed to prevent cross-contamination and ensure product quality.

• It involves a series of checks and documentation to verify that the equipment, area, and materials are ready for use.

• Line clearance is typically conducted by the IPQA (In-Process Qualit...read more

There are three types of line clearance: equipment line clearance, product line clearance, and area line clearance.

• Equipment line clearance involves ensuring that all equipment used in a production line is properly cleaned and free from any previous product or material.

• Product line clearance involves verifying that the previous product has been completely removed from the production line before starting a new product.

• Area line clearance involves ensuring that the production a...read more

Parenterals are sterile dosage forms that are administered through injection or infusion.

• Parenterals bypass the digestive system and are directly injected into the bloodstream.

• They include solutions, suspensions, emulsions, and powders for reconstitution.

• Parenterals require strict aseptic manufacturing and handling procedures to prevent contamination.

• Examples include insulin, vaccines, antibiotics, and chemotherapy drugs.

A medicine is a substance used to treat, cure, or prevent diseases or medical conditions.

• Medicines are typically formulated as tablets, capsules, liquids, or injections.

• They can be prescribed by healthcare professionals or available over-the-counter.

• Medicines can target specific symptoms or address underlying causes of diseases.

• Examples of medicines include antibiotics, painkillers, antihistamines, and vaccines.