Active Ingredients and Excipients
This 3-day Qualified Person (QP) Pharmaceutical Quality Systems training course provides trainee Qualified Persons and other pharmaceutical quality professionals with a thorough knowledge and understanding of the main requirements for suppliers of Active Pharmaceutical Ingredients (APIs) and other chemicals (excipients), used in the manufacturing of pharmaceutical products. The course meets all of the requirements of the UK Study Guide for trainee QP’s.
It is essential that any pharmaceutical quality professional has a detailed appreciation of the GMP and regulatory requirements for suppliers of starting materials and the whole supply chain. This three-day course covers the key regulatory guidance for suppliers of chemicals, as well as some the main techniques used to produce such materials. It is based on and includes all of the requirements of the latest UK: Qualified Person Study Guide for trainee QPs. The course is primarily aimed at trainee QPs, but will also be of great benefit to any new Quality Manager or Purchasing Manager, or anyone involved in the supply of incoming materials, who needs a greater appreciation of the importance of the quality of starting materials.
By the end of this module, you will have a comprehensive knowledge of the GMP requirements for the manufacture and supply of active ingredients and excipients.
Dates available to book
This course is available for in-house presentation, either on-site or virtually. Please contact us for further details.
Key Topics Covered
- The main key steps in the manufacture of active substances and excipients
- The main key steps in the manufacture of biological products
- GMP requirements for the manufacture of active substances and excipients
- The use of certificates of suitability
- Control of impurities, degradation products and infectious agents
- The use of solvents, catalysts and process aids
- Avoidance of contamination
- Process validation requirements
- Audit and QP declaration requirements
Who will the course benefit?
This course is aimed at trainee QPs as well and anyone working in, or moving into, more senior roles with the Quality and Supply Departments. It is ideally suited to Quality Assurance personnel who need to have a greater understanding of the importance of purchasing incoming materials of the right quality and all of the associated issues of the supply chain involved in delivering these materials to the site of manufacture of the finish pharmaceutical product.
Course Content
How much do you really need to know about the ingredients of a medicine?
As a QP, you may not need to be a synthetic chemist or molecular biologist, but there is still plenty you need to know about what goes into your product. After all – Garbage in = Garbage out
Regulatory requirements for API and Excipients including
– Registration of activities
– Licensing in product dossiers
– GMP / GDP for human and veterinary products
Key synthesis routes for chemical and biological entities
Control measures for impurities, degradation products
Process validation for APIs
This course is run in partnership with QP Quandary. You can book from this website or from their website.
If you are interested in booking, click on BOOK NOW above.
Course Cost
The cost of the Qualified Person (QP) Analysis and Testing training course is £2,100, plus VAT. Course will be charged in GB pounds.
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Inspired Pharma Training Ltd,
5 Westbrook Court, Sharrow Vale Road,
Sheffield, S11 8YZ, United Kingdom.



