Tag: quality risk management

Understanding ICH Guidelines Q11 for the Development and Manufacture of Drug Substance

“Explore the essential aspects of ICH Guidelines Q11 for the development and manufacture of drug substances. Our FAQs provide valuable insights into the scope, principles, and industry adoption of ICH Q11, guiding pharmaceutical professionals and stakeholders towards global regulatory compliance and excellence in drug substance quality.”

Understanding ICH Guidelines Q9: A Comprehensive Overview

Explore the comprehensive guide to ICH Q9, the “Quality Risk Management” guideline by the International Council for Harmonisation. Learn about its core principles, significance in the pharmaceutical industry, and how it empowers organizations to ensure product quality and patient safety. Stay informed on risk assessment, control, and review to navigate the complexities of drug development and manufacturing with confidence.

Possible Questions for Quality Assurance and Quality Control Interview in the Pharmaceutical Industry

Preparing for a quality assurance or quality control interview in the pharmaceutical industry requires a comprehensive understanding of the principles, techniques, and regulations involved. This article provides a comprehensive list of possible interview questions to help you prepare effectively and confidently. It covers topics such as the importance of QA and QC, key differences between them, regulatory compliance, documentation and recordkeeping, standard operating procedures, quality control techniques, compliance with regulatory agencies, managing non-conformances and corrective actions, ensuring product quality and safety, and continuous improvement initiatives. By studying these topics and familiarizing yourself with the FAQs provided, you will be well-equipped to showcase your knowledge and skills during your interview.