Online Good Manufacturing Practice training course
Gain an appreciation of the main requirements of Good Manufacturing Practice in an hour with this online GMP training course approved by the Royal Society of Chemistry Make a BookingCourse DetailsOnline GMP Training Course
This GMP online course is aimed at new starters and existing staff as part of their induction and/or ongoing GMP training. The Royal Society of Chemistry (RSC) Approved GMP online course provides a detailed overview of why we have GMP and what GMP is in three CORE chapters with ADDITIONAL chapters covering specific GMP requirements for different parts of the site. Versions available include:
- GMP for Manufacturing Personnel
- GMP for Packaging Personnel
- GMP for Warehousing Personnel
- GMP for Laboratory Personnel
- GMP for Engineering Personnel
- GMP for QA Personnel
A recent analysis of over 500 delegates completing the end of course survey showed that over 45% found the course “extremely valuable” as an introduction/refresher to GMP and it’s importance in their job. With a further 40% finding it “valuable”.
Key features of the online GMP course range include:
Access Anytime Anywhere
Using the internet, access the course via any computer, tablet or iPhone (or equivalent) anytime anywhere.
Bitesize learning
Fit your learning into a busy schedule. Most Chapters take between 15 to 25 minutes to undertake. Stop your learning anytime and resume where you left off.
Value for money
Whether there is a large group to be trained or just a few individuals it is very cost effective with prices starting at £95 per learner with substantial discounts available for multi-learner or internal systems purchases.
Certificate with RSC Approved Training logo
Every learner who completes the course can download a Certificate with our logo and the RSC Approved Training logo (only for courses that include the Core Chapters)
Role-specific training
You only need to undertake the Chapters that are relevant to your role.
Materials always up-to-date
Materials kept current and up-to-date as legislation changes.
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 purchased for use on your own internal systems. See an overview in the video opposite/below:
Make A Booking – Individual and groups of up to 10 people
Choose which version of our GMP Courses is right for you. All you need is an internet connection and any computer, tablet or iPhone (or equivalent) to access. You will be set up with access to the UK course by default. If you would prefer the non-UK course then send us an email once you have made your online booking.
Standard Versions
The standard versions consist of the 3 ‘Core’ Chapters plus a Chapter relating to your role. Click on the tabs below to make a booking,
Engineering Personnel
3 Core Chapters plus Chapter 8 as detailed in the section below. Duration: Around 60 minutes. Cost per learner £95 plus VAT
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Laboratory Personnel
3 Core Chapters plus Chapter 7 as detailed in the section below. Duration: Around 60 minutes. Cost per learner £95 plus VAT
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Manufacturing Personnel
3 Core Chapters plus Chapter 5 as detailed in the section below. Duration: Around 60 minutes. Cost per learner £95 plus VAT
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Packaging Personnel
3 Core Chapters plus Chapter 6 as detailed in the section below. Duration: Around 60 minutes. Cost per learner £95 plus VAT
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QA Personnel
3 Core Chapters plus Chapter 9 as detailed in the section below. Duration: Around 60 minutes. Cost per learner £95 plus VAT
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Warehouse Personnel
3 Core Chapters plus Chapter 4 as detailed in the section below. Duration: Around 60 minutes. Cost per learner £95 plus VAT
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Custom Versions
Custom versions are available. With the exception of the Single Chapter option, these consist of the 3 ‘Core’ Chapters plus additional Chapters of your choice. relating to your role. After you have booked please contact us to let us know your selection. Click on the tabs below to make a booking,
GMP Core plus 2 Chapters
Duration: Around 75 minutes Cost per learner £120 plus VAT
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GMP Core plus 3 Chapters
Duration: Around 90 minutes Cost per learner £145 plus VAT
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GMP Core plus 4 Chapters
Duration: Around 115 minutes Cost per learner £170 plus VAT
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GMP Core plus 5 Chapters
Duration: Around 130 minutes Cost per learner £195 plus VAT
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GMP Core plus 6 Chapters
Duration: Around 150 minutes Cost per learner £220 plus VAT
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GMP Single Chapter
You can purchase just a single Chapter from the list below BUT please note the RSC have only approved the versions that include the Core Chapters. So, the Certificate will not feature the RSC logo. Cost per learner £45 plus VAT
Click here to book
What is involved?
Select the tabs below to find out all the details you need to know to make a booking and start the course:
Course cost
The individual price for access to the three CORE chapters and one ADDITIONAL chapter is £95. Extra additional chapters are charged at £25 each. See below to purchase.
However delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company’s national VAT number when booking. VAT will not be charged for any delegates coming from outside the EU.
What's included in cost
- Access to the course via our online Academy for a 2-month period from their registration as a delegate. You will need to pay again to complete the course once this access perios has lapsed.
- A certificate with an RSC Approved Training logo (except for Single Chapter course purchases). No certificate is issued if the course is not completed in full.
- Administrative support to ensure access to the course. We reserve the right to charge for additional administration requests.
Payment
Payment can be made by cheque, electronic transfer, credit or debit card. Course registration will follow soon after payment has been received.
If you plan to pay by credit card then you should first look at this helpful information.
Based Outside the UK?
If so, be sure to pick the ‘Tax Exempt’ options in the payment method list when you are making a booking. If you are based in the EU then you must also enter your VAT number to qualify to be exempt from VAT.
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.
Free Taster Courses
To try a free taster of these courses to see if they work for you visit this page.
Larger groups
For larger groups groups of 10 or above who wish to take the course using our platform there are discounts available which increase depending on numbers. Alternatively you may wish to license our courseware to run on your own internal system. See below for more details on either option:
It is very easy and straightforward to set up your users on our system, no matter whether the group comprises just 10 people or several hundred. The largest roll-out we have handled is for over 500 learners, but there is no technical limit on the group size.
We just need the learners’ name, email address and course choice – sent to us in an Excel file and hours later your team can be undertaking their course.
Alternatively, you can purchase a number of licenses and either you, your admin personnel or your learners can add themselves to the system.
Whichever works best for you.
Once your learners are on our system you or your own internal admin personnel can very easily monitor their progress and produce the reports needed for compliance reporting.
Please contact us for further information.
If you are interested in licensing the course materials for use on your own Learning Management Systems (LMS) then please contact us to discuss options.
Versions include:
- SCORM 1.2
- SCORM2004
- AICC
- Tin Can API
- cmi5
GMP Online Course contents
Typically delegates do all three CORE chapters and any ADDITIONAL chapters that are relevant to their role. For example, a person working in the Packaging department will undertake Chapters 1 to 3 and Chapter 6. The duration of each chapter lasts approximately 10 – 15 minutes. The standard 4 chapter course should last about an hour.
CORE Chapters
The CORE chapters shown below are available either as
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.
- Welcome to the course.
- The pharmaceutical industry.
- Medicines and what they do.
- Different types of medicines.
- Laws
- Protection of the end-user (the patient).
- The main challenge when it comes to making medicines.
- The importance of trust.
- Historical problems with medicines.
- The impact of people handling medicines on product quality and the end user.
- Chapter summary.
- Assessment. 10 random questions will be selected.
Duration: 10 – 15 minutes
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.
- The importance of the safety, efficacy and quality of medicines.
- Good Manufacturing Practice and Good Distribution Practice.
- Working to the highest possible standards.
- The role of Good Manufacturing Practice.
- Licences and authorisations for those who manufacture and handle medicines.
- The Regulatory Authority and Regulatory Inspections.
- Manufacturing Authorisations.
- Why is GMP important?
- The Golden Rules of GMP.
- Chapter summary.
Assessment – 10 random questions will be selected
Chapter 3 The Good Manufacturing Practice guidelines
The main contents and requirements of the 9 chapters of EU GMP are explained and why these are
important. Reference is also made to the additional requirements in the Annexes of EU GMP.
- The role of GMP in the medicine’s supply chain.
- Maintaining product of the right quality.
- Control over falsified medicinal products.
- The structure of EU GMP.
- EU GMP Chapter 1 – Pharmaceutical Quality System.
- EU GMP Chapter 2 – Personnel.
- EU GMP Chapter 3 – Premises and Equipment.
- EU GMP Chapter 4 – Documentation.
- EU GMP Chapter 5 – Production.
- EU GMP Chapter 6 – Quality Control.
- EU GMP Chapter 7 – Outsourced Activities.
- EU GMP Chapter 8 – Complaints, Quality Defects and Product Recalls.
- EU GMP Chapter 9 – Self-inspection.
- The Annexes of EU GMP.
- Assessment – 10 random questions will be selected.
Duration: 15 – 20 minutes
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.
To try a free taster of these courses to see if they are of interest visit this page.
Chapter 4 GMP in the Warehouse
This chapter covers the key GMP requirements for the warehouse and is designed for people working in this area.
- The role of the warehouse.
- The facility.
- Incoming materials.
- Identification.
- Sampling.
- Storage.
- Issue to Production.
- Dispensing.
- Finished product.
- Dispatch.
- Rejected and returned materials.
- People.
- Chapter summary.
- Assessment – 10 random questions will be selected.
Duration: 10 – 15 minutes
Chapter 5 GMP in Manufacturing
This chapter covers the key GMP requirements for manufacturing and is designed for people working in this area.
- The role of manufacturing.
- Correct raw materials.
- Equipment and area.
- Procedures.
- Instructions and records.
- Use of equipment.
- Validation and change control.
- General rules.
- Sampling and In-Process Control.
- Reporting problems.
- Cleaning.
- Clothing.
- People and hygiene.
- Chapter summary.
- Assessment – 10 random questions will be selected.
Duration: 10 – 15 minutes
Chapter 6 GMP in Packaging
This chapter covers the key GMP requirements for packaging and is designed for people working in this area.
- The role of packaging.
- Types of packaging.
- Incoming materials.
- Equipment and area.
- Line set-up.
- Segregation.
- Procedures.
- Instructions and records.
- In-Process Control.
- QC Samples.
- Sensors and rejects.
- Reconciliation.
- Line clearance.
- People and hygiene.
- Chapter summary.
- Assessment – 10 random questions will be selected.
Duration: 10 – 15 minutes
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 this area.
- The role of Quality Control.
- QC sampling.
- Sampling requirements.
- Samples.
- Testing.
- Results.
- Approval of results.
- Identification of laboratory chemicals.
- Data Integrity and data within equipment.
- Reference samples.
- General rules of the laboratory.
- Chapter summary.
- Assessment – 10 random questions will be selected.
Duration: 10 – 15 minutes
Chapter 8 GMP for Engineers
This chapter covers the key GMP requirements for Engineering personnel.
- The role of Engineers.
- The whole facility.
- The facility.
- Equipment.
- Other requirements.
- Engineering responsibilities.
- The Engineering department.
- Control of equipment.
- Maintenance.
- Spare parts.
- Calibration.
- Before you start.
- As you work.
- When you have finished.
- Documents and records.
- Chapter summary.
- Assessment – 10 random questions will be selected.
Duration: 15 – 20 minutes
Chapter 9 GMP for QA personnel
This chapter covers the key GMP requirements for QA personnel.
- The need for a QA system.
- Key personnel.
- Lack of real guidance on QA.
- The Quality Department.
- What should QA do?
- Common roles for QA.
- Validation.
- Documentation.
- Keeping records.
- Training.
- Supplier approval and external audits.
- Change Control.
- Complaints.
- Investigations and Route Cause Analysis.
- CAPAs.
- Risk assessments.
- Internal audits.
- Review of batch records.
- Analysis of data.
- Product Quality Review.
- Management Review.
- Improvements.
- ICH Q9 and Q10.
- Chapter summary.
- Assessment – 10 random questions will be selected
Duration: 20 – 30 minutes
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We help people in Pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for inhouse delivery at a client site.
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Forthcoming Public Courses
All of our public courses are being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together.
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21 Advanced Good Manufacturing Practice
28 Good Manufacturing Practice
October
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16 Advanced Good Manufacturing Practice
December
Online courses available anytime anywhere
Good Distribution Practice (GDP)
Good Manufacturing Practice (GMP)
Pharma Quality Management Systems module
QP Medicinal Chemistry & Therapeutics module
QP Quality Management Systems module
Each course typically consists of 10-20 minute chapters of content followed by a quiz based assessment. The QP courses feature tutor assessment too. The learning is accessed over the internet using desktop computers, laptops, tablets and even smartphones.
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