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Module 2: Good Manufacturing Practices (GMP) and Good Documentation Practices
WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization”.The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. GMP is aimed primarily at diminishing the risk inherent in any pharmaceutical production. Such risks are essentially of two types: cross-contamination (in particular, with unexpected contaminants) and mix-ups (for example, false labeling).
Module Objectives: By the end of the course, delegates shall
• Have an awareness of the basic requirements of GMP
• Be aware of the ten golden principles of GMP
• Understand the roles and responsibilities associated with GMP
• Be able to contribute to and maintain quality documentation
• Understand the requirements of GMP in the QC laboratory context
• Understand the need for quality systems and quality assurance activities
Learning Outcomes: Delegates will be able to
• Implement their role within GMP with confidence and knowledge of the principle requirements
• Contribute effectively to the GMP quality system and their organisation’s compliance
• Know where to seek further information within the published rules and guidance, WHO, FDA, ICH Guidance and other relevant publications, as well as via the internet
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Module 3: Good Laboratory Practices (GLP)
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Module 1: Types of Quality Tools and Total Quality Management
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Module 4: ISO 9000, ISO 14000, ICH GCP and Schedule Y
This module helps to create a basic understanding of a set of international standards such as:
ISO 9000 which is a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system
ISO 14000 a set of standards which specify requirements for establishing an environmental management policy, determining environmental impacts of products or services, planning environmental objectives, implementing programs to meet objectives, and conducting corrective action and management review.
To gain fundamental knowledge of Good Clinical Practice (GCP), an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
To get a preliminary idea on Schedule Y which describes the details of application process for conducting clinical trials; responsibilities of the investigators in India.
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Module 5: Cleanroom Technology
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Final Test
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