This half-day workshop is mainly dedicated to those professionals from the Pharmaceutical Industry involved with the formulation, filling and lyophilization operations. Topics, starting from the plant design to the validation of each of critical operation related to the production of a lyophilized drug will be described. The workshop will give the opportunity to discuss practical examples on how to fulfil the current GMP.
Topics
1. Introduction:
- What is the Good Manufacturing Practices (GMP)?
- What are the reasons for GMP?
- What is a sterile product?
- How to get a sterile product?
- An overview of the regulations and guides.
2. Plant design:
- Components flow (Critical, Supporting and Separation Clean Areas).
- Clean room characteristics.
- Some topics about air filtration.
- Points to consider designing a clean room facility for the production of a lyophilized product?
- Multiproduct facilities including the lyophilization process.
- Example of a real case. Conflicts found during the facility design
3. Personnel:
- Code of conduct into a clean room.
- Training, qualification and monitoring of the manufacturing personnel. Additional training for personnel involved to the lyophilization process.
- Training and qualification of the laboratory personnel.
- Training and qualification of supervision personnel. Recommended ways to get an effective supervision.
4. Components and Container/Closure Systems:
- Water for Injection. Obtaining methods. FDA and EMEA's point of view.
- Components Sterilization.
- Sterile filtration of pharmaceutical solutions and its validation. FDA and EMEA's point of view.
- Container/Closure system. Specificity for lyophilized products.
5. Environmental Monitoring:
- Monitoring program.
- Monitoring methods.
- Microbiological and particle monitoring. Particular case for a freeze dryer.
6. Simulation for aseptic processes, including the lyophilization step.
- Points to include during the study.
- Frequency, number, duration and size of runs.
- Environmental conditions.
- Media. Incubation and examination of media-filled units.
- Interpretation of test results.
7. Freeze dryer equipment and process.
- Loading operation.
- Cleaning operation. Design and validation.
- Sterilization process and its validation.
- Process design and validation. Impact of the formulation and their thermal properties. Some common problems found during the lyophilization process.
8. Final review.