Pharmaceutical Quality Assurance MCQ With Answers

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.

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.

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.

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.

Installation Qualification (IQ) is one of the four main phases of qualification for equipment and accessories in regulated industries such as pharmaceuticals, biotechnology, and medical devices. During the IQ phase, the physical dimensions of the equipment and accessories are verified to ensure that they meet the specifications and requirements set forth in the design documents. This includes checking the size, shape, and positioning of the equipment, as well as verifying that all required accessories are present and functional.

A bubble airlock is designed to maintain a pressure differential between two areas with different pressure levels. It typically has a lower pressure inside the airlock chamber and higher pressures on both the entry and exit sides. This configuration prevents contaminants from entering the cleaner area (with higher pressure) and helps maintain the integrity of the controlled environment.

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.

In the context of calibration, validation is used to confirm that the calibration process and the calibrated equipment or processes are performing as intended.

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  Equipment: Validation ensures that the measuring equipment is providing accurate and reliable results within the specified tolerances after calibration.

  
  


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  Processes: Validation confirms that the calibrated processes are producing consistent and predictable outcomes that meet the required quality standards.

  
  

In essence, validation is a critical step in the calibration process to ensure the overall accuracy and reliability of measurements and processes.

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.

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.