Introduction
Active Pharmaceutical Ingredients (APIs) are the essential components of pharmaceutical products responsible for the intended therapeutic effect.They form the backbone of pharmaceutical formulation and their quality directly impacts the safety and efficacy of the medicines which directly impacts public health. The National Agency for Food and Drug Administration and control (NAFDAC) has recognised the need to encourage, build capacity and strengthen the regulators and local manufacturers with all that’s required to explore this critical area in the healthcare system thereby improving access to safe, effective and affordable medicines This training program aims to provide comprehensive knowledge and practical skills on various aspects governing APIs.
Training Objectives
- Equip participants with a thorough understanding of the regulatory framework for APIs, encompassing development, manufacturing, and quality assurance.
- Deepen knowledge of key topics including Dossier Review, Raw Materials, Intermediates, API and Impurities, Packaging, Analytical Method Validation, and Stability Monitoring.
- Empower participants to navigate the complexities of API regulations and guidelines effectively.
- Foster the ability to contribute to the development and maintenance of high-quality pharmaceutical products, ensuring public health and safety.
Target Audience
- Regulatory professionals in the National Regulatory Authority (NRA).
- Quality assurance personnel involved in API manufacturing.
- Scientists and researchers developing new APIs in the academia.
- Regulatory affairs personnel interacting with regulatory agencies.
- Regulators from NRA’s within the West African region.
Training Content
- Topic 1: Introduction to API Regulations
- Global Regulatory Landscape for APIs (ICH Q guidelines, WHO guidelines)
- Regulatory Authorities and their Roles
- Overview of the API Development Process
- Topic 2: Dossier Preparation and Review
- Common Technical Document (CTD) for APIs
- Essential Elements of an API Dossier
- Strategies for Effective Dossier Preparation and Review
- Topic 3: Quality Management of APIs
- Good Manufacturing Practices (GMP) for APIs (ICH Q7)
- Quality Control (QC) Testing of APIs
- Impurity Profiling and Management
- Packaging and Labelling Requirements
- Topic 4: Analytical Methods and Stability
- Validation of Analytical Methods for APIs
- Stability Testing Programs and Data Analysis
- Control Strategies for Maintaining API Quality
Training Methodology
The training will be a hybrid training with in-person participants and online participants utilizing a blend of interactive learning methods, including;
- Presentations by subject matter experts
- Case studies and workshops to apply acquired knowledge.
- Q&A sessions to address specific participant queries.
Expected Outcomes
Participants who complete the training will be able to:
- Apply their knowledge of API regulations and guidelines to their professional roles.
- Effectively navigates the regulatory requirements for API development, manufacturing, and quality control.
- Contribute to the development of high-quality APIs that ensure patient safety and public health.
- Provide effective guidance to regulatory requirments for API’s and compliance to required standards.
