Who will the course benefit?
We offer a series of online modules that are used for GMP compliance training, or as part of a GMP induction programme to introduce new starters to Good Manufacturing Practice. These modules can also be used as part of on-going GMP refresher training for existing personnel. In addition, the courseware can be customised, if required, for your site or company. And, can be licensed for use on your own internal systems.
CORE Chapters
The CORE chapters shown below are available either as a UK or non-UK version. The UK version has references to the UK’s Regulatory Authority (the MHRA) and their “Orange Guide”, whereas the non-UK version does not.
Chapter 1: An introduction to the pharmaceutical industry
This chapter provides an overview of the pharmaceutical industry and the need to regulate medicine manufacture and supply.
Chapter 2: An introduction to Good Manufacturing Practice
This chapter introduces the concept of Manufacturing Authorisations for sites and Marketing Authorisations for medicines and the need for Good Manufacturing Practice at sites making pharmaceuticals.
Chapter 3: The Good Manufacturing Practice guidelines
The main contents and requirements of the 9 chapters of European Union GMP (EU GMP) are explained and why these are important. Reference is also made to the additional requirements in the Annexes of EU GMP.
ADDITIONAL Chapters:
These are specific for different parts of the site, and typically a delegate will also take one of these, depending on which area they work in.
Chapter 4: GMP in the Warehouse
This chapter covers the key GMP requirements for the warehouse and is designed for people working in good-in or despatch.
Chapter 5: GMP in Manufacturing
This chapter covers the key GMP requirements for manufacturing and is designed for people working in manufacturing areas.
Chapter 6: GMP in Packaging
This chapter covers the key GMP requirements for packaging and is designed for people working in packaging.
Chapter 7: GMP in the Laboratory
This chapter covers the key GMP requirements for the Quality Control laboratory and is designed for people working in the laboratory.
Chapter 8: GMP for Engineering personnel
This chapter covers the key GMP requirements for people working in the Engineering function.
Chapter 9: GMP for QA personnel
This chapter covers the key GMP requirements for people working in the Quality Assurance function.
Assessment and certificates:
Each chapter has a series of randomly selected assessment quiz questions at the end of each one. An 80% pass mark is expected. Guidance is provided if a delegate gets an answer wrong. After successful completion of the course, a certificate is available for download by the delegate.
ONLINE: Available Anytime Anywhere using a desktop pc, laptop, tablet and most smartphones.
Organisations purchasing multiple copies of this course are able to appoint team administrators to oversee the programme, monitor progress of their team and print certificates for training records.
For more details visit our website using the link on this page.
Access to the internet is the only requirement.
Additional infoONLINE: Available Anytime Anywhere using a desktop pc, laptop, tablet and most smartphones.
Online
1 hours
£95.00 GBP (plus VAT)
Use the options below to search through the growing list of chemical sciences training courses that have been approved by the Royal Society of Chemistry.
Courses are approved for CPD purposes only; approval does not imply they will fulfill any regulatory requirements.