GMPs and QA oversight for packaging operations
- GMP requirements in the packaging unit
- Important Guidelines and standards
- QA Systems relevant for packaging operations
- Frequent inspection findings
General GMP requirements for Packaging Operations / Key Compliance Challenges for Packaging Operations
- Handling and storage of packaging materials
- Stability issues
- Material storage, returned goods, quarantine
- Line Clearance
- Documentation practice
- Practical GMP aspects
- Good and bad practice
Packaging facilities & premises
- Requirements for the technical building equipment
- Zone Concepts for primary and secondary packaging
- Air-Lock concepts
GMP Design Aspects for Packaging Lines
- Design criteria for blister machines, cartoners, labelers
- Differences to aseptic filling / packaging
- What is critical?
- What to write in an URS?
Case Study: Serialization and Aggregation– How we implemented, what worked and what didn’t
- Areas to be addressed: IT system – carton – processes
- Challenges in the implementation phase
- Equipment qualification/ process validation
- Packaging material management
- Impact on the Supply Chain
- Handling of Failures / Deviations / Complaints
- Workshop on Qualification and Validation
- Equipment qualification
- Process validation
- Critical issues which have to be tested
- How to test?
- Workshop on Packaging
- Secondary Packaging (including Medical Devices)
Interactive Session on Packaging of highly Potent Products / Q&A Dynamic session on packaging (tips & problems)
- Cross Contamination – how to avoid it:
- 1 – dedicated vs multi product facility
- 2 – production planning
- 3 – cleaning procedures
- 4 – people movement
Case Study: Quality and Compliance systems in the packaging plant
In this case study the different systems in place in a packaging plant of Boehringer Ingelheim GmbH & Co. KG at Ingelheim site are presented, e.g.
Hygiene and Zone Concepts
- Material flow
- Line clearance procedure
- IPCs in the packaging process
- Documentation and control
- Handling of variable printing data
How to minimize risk in Sterile Packaging
- What can go wrong in sterile packaging?
- How to minimize these incidents applying QRM principles.
- Aseptic filling and terminal sterilization:
- Microbiological quality of the primary packaging components
- Media Fill
- Container Closure Integrity (CCI)
The application of GxP in packaging supply
- Relevant ISO standards
- Introduction to British “GMP for Packaging Materials”: PS 9000:2016
Reducing risk through supplier auditing
- How much GMP must a supplier have?
- Practical audit aspects: what to examine?
- Qualification of suppliers