Unlicensed Medicines
This course covers Unlicensed Medicines and their manufacturing requirements, handling, storage, and processes required for correct and proper function in this field.
There are serious risks posed by errors, poor product or product component quality, or simply not paying attention to the correct documentary procedures involved in Unlicensed Medicines.
As always, patient safety is the ultimate goal and it cannot be stressed enough that robust Quality Management Systems and Procedures (including processes for meta data and hard copy documentation, procurement, customer care, QC, QA and production staff) is an absolute must.
Unlicensed Medicines is a large and involved topic. This course is designed to instil GDP awareness into all members of staff in order to attain the required degree of compliance competence. (See the EU GDP Guidelines 2013/C 343/01 chapter 2 section 4 for further reading).
The learning objectives of our Good Distribution Practice (GDP) Awareness course are:
• Understanding the best practices and processes for safe handling and storage of unlicensed medicines.
• Understand the importance of key QMS processes and it’s impact on patient safety.
• Be aware of personal accountability and impact on good manufacturing processes.
• To understant compliancy requirements of Senior Management
You will also learn about:
• Licensing Requirements
• Manufacturing Cleanroom requirements
• Key QMS processes
• Quality Metrics (trending data)
• On or Off-site QC Testing
• Conformity and Analysis Certification
• What to look for in Counterfeit and Falsified Meds
• Warehouse Processes, including Goods In and Despatch
• Secondary Packaging
Click the button below for supporting documentation about GDP if you wish to continue your learning journey.
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Help and Support
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Ratings and Reviews
Rajesh Matthew
Very useful
Clean rooms are important.