Summary
The specifications applied to drug products and raw materials used in the production of medicines are important elements in safeguarding patient safety and ensuring drug product efficacy. Regulators will expect to see proposed specifications in a drug product marketing application that control important quality attributes within suitable limits. The purpose of this course is to help applicants to decide which attributes to control in written specifications and how to approach setting appropriate values for each parameter, both at release and over the shelf life of the product. Topics include current regulatory guidance, including upcoming changes, using risk assessments to control attributes such as residual solvents and elemental impurities, specifications for selected novel dosage forms, justifying new impurities in generic drug products, and the control of genotoxic impurities. An important element to consider in the control of pharmaceutical materials is the suitability of the test methods used for each quality attribute. Recent USP and ICH guidance suggests that regulators will focus on this area in the coming years, and this important topic is covered in the course. Each day will include a workshop that will reinforce the learning points.
Learning Objectives
- Current regulatory expectations
- How to set meaningful specifications for raw materials and drug products
- Using the principles of quality risk management for impurity control
- Avoiding common errors and omissions
Key Topics
- Regulatory guidance
- Specifications (ICH Q6A)
- Impurities (ICH Q3 family of guidance documents)
- Genotoxic impurities (ICH M7)
- Risk assessments for residual solvents, elemental impurities and extractables
- Excipient specifications
- Control of drug substance vs. drug product
- In-process specifications and parametric release
- Release vs. shelf life specifications
- Specifications for specific dosage form types
- Oral liquids/solids
- Parenteral drug products
- Topical drug products
- Inhalation drug products
- Liposomes
- Justifying new impurities in generic drug products
- Test method suitability
- A risk-based approach to the control of genotoxic impurities
Who should attend?
Analytical Development Scientists, Pharmaceutical Development Scientists, Quality Control Personnel, Quality Assurance Professionals, Regulatory Affairs Specialists, Project Managers, Process Development Scientists, Consultants
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainer
