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This 3 day course systematically builds up the knowledge of delegates over three intensive days. It covers the regulations and guidelines associated with GMPs and the expectations of the MHRA and FDA. Topics examined include incoming materials, including control of suppliers of APIs, excipients and packaging materials. Other sessions examine manufacturing, packaging, premises, equipment, engineering activities, quality systems and laboratory practices. The course is highly interactive and also features several real-life case studies.

Classroom courses

Please note, the advertised venue may need to be changed, if the required number of delegates is not met. In this situation, the course will be converted to an Online Virtual course and all delegates notified accordingly. The decision regarding the venue will be made at least 4 weeks before the course is due to run.

The course covers the following topics:

Day 1

• Why do we have GMP.
• UK legislation and licensing
• Human and veterinary medicines regulations
• Relationship to EC directives
• Pharmaceutical quality system
• Role of MHRA
• How to use the orange guide

Day 2

• GMP in the USA
• Key people and training
• Control of Incoming materials
• Overview and principles of ICH Q9
• Change management
• Premises and equipment
• Pharmaceutical supply chain
• GMP audit points in production
• GMP audit points in packaging
• Deviations and investigations

Day 3

• GMP, QC and GQCLP
• Calculations, results and OOS
• GMP and documentation
• Validation and qualification
• Auditing and self-inspections
• Contracting out
• Complaints and recall

Prerequisites

This course is aimed at key personnel working in management, QA, QC, production, engineering and clinical trials, who wish to have a broader and more extensive appreciation of pharmaceutical good manufacturing practices.