Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products, particularly in the manufacture of sterile medicinal products. Major changes have recently been made to the EU GMP guideline covering manufacture of sterile medicinal products (Annex 1).
This webinar is designed for staff who are new to working in sterile manufacturing or who wish to learn about the recent Annex 1 revisions. It will discuss what controls and documentation must be in place to ensure product quality and patient safety for both aseptically prepared and terminally sterilized products.
- GMP regulation of sterile products
- Why are sterile products different?
- Background to the Annex 1 guideline
- Importance of product, equipment and people flow
- Room classifications and particulate monitoring
- Sterilization methods for materials and equipment
- Contamination by operators: the importance of gowning
- Water systems
- Media fills
- Staff involved with manufacture of sterile medicinal products to be marketed in EU
- Quality Assurance Departments
- Manufacturing Departments
- Regulatory Affairs Departments
- Research and Development Departments
- GMP/GDP Compliance Departments
- Contract Manufacturing Organizations