Pharmaceutical Quality Assurance MCQ With Answers

Explanation
QA stands for Quality Assurance and QC stands for Quality Control. Quality Assurance refers to the systematic process of ensuring that a product or service meets specified requirements and standards. It involves the development and implementation of processes and procedures to prevent defects and errors. Quality Control, on the other hand, is the process of inspecting, testing, and evaluating a product or service to ensure that it meets the desired quality standards. It involves monitoring and measuring the quality of outputs and taking corrective actions when necessary.

Explanation
The objective of the ISO-9000 family of Quality management is to ensure customer satisfaction. This means that the standards and guidelines set by ISO-9000 aim to help organizations meet customer expectations and deliver products or services that meet their needs and requirements. By implementing a quality management system based on ISO-9000, organizations can improve their processes, enhance customer satisfaction, and ultimately increase their competitiveness in the market.

Explanation
P-D-C-A stands for Plan-Do-Check-Act. This is a four-step management method used for continuous improvement in various processes. It involves planning the desired outcome, implementing the plan, checking the results against the objectives, and taking necessary corrective actions to improve the process. This cycle is repeated to ensure ongoing improvement and efficiency in organizations.

Explanation
Validation in calibration refers to the process of ensuring that a particular process or equipment meets the specified requirements and standards. It involves verifying and documenting that the measurements or results obtained from the process or equipment are accurate and reliable. Therefore, the correct answer is "Processes" as validation is primarily associated with validating the accuracy and reliability of processes rather than equipment.

Explanation
The physical dimension of equipment and accessories is a characteristic that is assessed during the design qualification (DQ) process. DQ involves evaluating and verifying that the design of the equipment and accessories meet the specified requirements and standards. This includes assessing factors such as dimensions, materials used, and overall design features. Installation qualification (IQ) focuses on verifying that the equipment is installed correctly, operational qualification (OQ) ensures that the equipment operates within specified parameters, and performance qualification (PQ) tests the equipment's performance under normal operating conditions. However, none of these qualifications specifically address the physical dimension of equipment and accessories, making DQ the correct answer.

Explanation
The correct answer is Grade C. Grade C is the appropriate environment for filling products for terminal sterilization. This grade provides a controlled and clean area with limited microbial contamination. It ensures that the products are protected from contamination during the filling process, reducing the risk of any potential microbial growth. Grades A and B are typically used for more critical operations, while Grade D is a less controlled environment.

Explanation
A sink airlock refers to a situation where there is low pressure inside the airlock and high pressure on both outer sides. This creates a pressure differential that causes air or fluid to flow from the high-pressure areas to the low-pressure area, similar to how water flows down a sink drain. This term is commonly used in the context of fluid dynamics and can occur in various systems, such as pipelines or ventilation systems.

Explanation
The leakage test is not a QC test for parenteral containers because it is not specifically related to the quality control of the containers themselves. The purpose of a leakage test is to ensure that the container is properly sealed and does not leak any contents. While this is an important test for ensuring the integrity of the product, it is not directly related to the quality of the container itself. The other tests mentioned, such as the sterility test, clarity test, and pyrogen test, are all specifically designed to assess the quality and safety of the parenteral containers.

Explanation
ISO-14000 is the correct answer because it is a set of international standards that provide guidelines for organizations to establish and maintain an effective environmental management system. These standards help organizations identify and control their environmental impact, comply with regulations, and continually improve their environmental performance. ISO-14000 covers various aspects of environmental management, including environmental policy, planning, implementation, operation, performance evaluation, and corrective actions. It is designed to help organizations minimize their negative impact on the environment and promote sustainable practices.

Explanation
Q1E stands for the guideline on Evaluation of Stability Data. This guideline provides recommendations on the evaluation of stability data for pharmaceutical products. It outlines the principles and procedures for conducting stability studies and determining the shelf life of drugs. The guideline helps ensure that pharmaceutical products remain safe and effective throughout their shelf life.