GMP for Quality Control for Pharmaceuticals

This introductory course provides a basic understanding of Good Manufacturing Practice for Quality Control Laboratories in the pharmaceutical industry. You’ll learn about the role and responsibilities of the QC organisation at a manufacturing site and you will get a broad understanding of work procedures, authorities’ expectations, and best practices within the QC area.

The course includes a high-level overview on the applicable regulations in the EU and US. Enhance your skills to ensure your pharmaceutical products meet the quality requirements to ensure safe and efficient products for patients.

This training has been developed by the experts at GBA Key2Compliance. The films are animated and designed to enhance understanding and perception of the presented concepts and are presented by an AI-generated speaker.

The training is divided into 2 modules: a general presentation and short exam. After the successful completion of both modules, you will receive your Certificate of Completion.

Content

• Key concepts and requirements for GMP Laboratories including Raw material lab, Microbiological lab and In Process and Final Container Labs.
• Introduction to QC relevant regulations and guidelines in EU and US, including EudraLex, CFR, ICH, and Pharmacopoeias.
• Requirements and common practices when conducting analytical measurements including sampling and testing, risk-based work methods, handling of chemicals, reagents and standards, as well as purpose and handling of reference and retention samples.
• Validation of analytical methods and qualification and maintenance of instruments.
• Assuring data integrity through robust documentation and reporting practices as well as management of Out of Specification (OOS) and Out of Trend (OOT) results and CAPA management.

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