Active Substances and Excipients
This Active Substances (AS) and Excipients training course provides a unique insight into the regulatory expectations for producing chemically synthesized and biological/biotech ASs. It also covers global AS supply chain management, vendor quality assurance and practical guidance on auditing AS facilities. We summarise key steps for identifying and removing impurities, including updated considerations around potential nitrosamine formation. The course also includes visits to Active Substance manufacturing facilities to see how requirements are applied in real operations.
This course fulfils the requirements of the Qualified Person Study Guide and is designed not only to help you pass a viva but to prepare you for your future career.
This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development.
Course Content
For chemically synthesized and biological/biotech APIs, the course includes:
- Common process steps and their impact on final drug substance quality
- EU and US regulatory requirements
- Comparison and contrast of AS facilities
- How GMP is applied across production, from starting materials to packaging and distribution
- Vendor assurance and supply chain management, including facility auditing
Course Outline
- Active Pharmaceutical Ingredients
- The regulations
- EU and US regulations and guidelines
- Active Substance master files and certificates of suitability
- Key GMP guidance – EudraLex Volume IV Parts 2 and 4 and Annex 2
- Manufacturing processes and quality
- Key issues for synthesis, purification, impurity control and packaging
- Supply issues for dosage form manufacturers
- Supplier selection and audit
- Supply chain integrity
- Technical/quality agreements
- Certificates of analysis
- Bulk Biologicals and Biotech Products
- What constitutes a biological or biotech product
- EU and US regulatory aspects
- Essential characteristics of biologicals
- Premises and facilities
- Quality aspects
- Control of starting materials
- Control of cultivation, harvest and purification
- Reducing viral contamination risk
- QC strategy for biopharmaceuticals
- Excipients
- Regulatory environment
- GMP guidances and codes
Course Tutors
David Waddington – Over 30 years’ pharmaceutical experience in global quality roles. A Qualified Person under permanent provisions with broad QA and manufacturing expertise across solids, liquids, sterile products, food supplements and natural products.
Neil Wayman – Senior quality professional with 30+ years’ experience as both QP and RP in API, solid dose and sterile injectable manufacture, with extensive quality systems, inspection and supply chain assurance experience.
Ian Pardo – Experienced QP with senior roles in sterile, biologic and ATMP manufacturing. Expertise includes PQS, validation, supplier auditing, supply chain setup and remediation of investigational and licensed sites.
Discounts
Multiple delegate discounts are available on this course. Please contact us at [email protected] for further information. NHS staff will receive an automatic discount when registering with an NHS email address.
Learning Outcomes
As AS supply chains become ever more diverse and cost pressures more acute, the pharma manager needs a keen appreciation of risk factors, design, control and monitoring of AS sources. This course allows delegates to differentiate between natural variation and risk across a range of AS processes, indicating the most appropriate and proportionate actions to take to mitigate any areas of concern.
You will be provided with an overview of the EU and US regulatory framework surrounding active substance and excipient manufacturing process and be given practical guidance on the key responsibilities of the Qualified Person when approving a GMP declaration.
You will also learn:
- How to meet EU and US Regulatory requirements and GMP guidance
- The major differences between chemical synthesis and bioprocesses; and contrasting both against drug product formulation
- How to manage change of AS source
- How to audit and provide QA oversight of excipients and Active Substances
- The course will also allow you to make informed decisions when faced with a range of GMP non-conformances during AS production.
Our detailed educational material grows into a lifelong reference library.
Who Should Attend
The Aspiring Qualified Person
- Our training is generally considered the best available and our QPs are held in high regard in the industry.
- As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries including Ireland, the Netherlands, Austria, Hungary and Malta.
- You are more likely to become a QP with us than with any other training provider.
The Pharmaceutical Technical Professional
- Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control.
- Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.
Need help choosing?
Our training advisors can help you find the perfect match.