26-27 February 2019
David Abraham, QRS & Project Leader in the development of the PS 9000:2016
Maren Göpfert, Boehringer Ingelheim Pharma
Dr Afshin Hosseiny, ECA & former Director of Quality Assurance, GSK
Dr Jean-Denis Mallet, NNE Pharmaplan, France
This GMP training course aims at easily explaining the GMP requirements for packaging of medicinal products. This includes requirements for premises and equipment but also for QA operations like documentation, line clearance, validation etc.
Packaging of medicinal products, blistering as well as cartoning for example, plays a crucial role in the quality and safety of a medicine. Deficiencies of primary packaging may alter the efficacy or stability of a product; failures in secondary packaging may do harm to patients even worse when products or the folding boxes are mixed up. Therefore, packaging is defined as (the last) pharmaceutical manufacturing step and one of the most critical ones. It is not surprising that the biggest part of recalls is caused by failures during packaging. The FDA reported that more than 30% of recalls of tablet products during the last 5 years were caused by label mix-ups, incorrect packaging or incorrect products insert. On the other hand, despite the high criticality of the packaging process, the packaging plants are required to cut the costs and raise their efficiency.
Another challenge for the packaging units is the new EU Directive, requiring safety features and authentication measures in order to raise the hurdle for drug counterfeiters. As a consequence of the “COMMISSION DELEGATED REGULATION (EU) 2016/161”, the rules apply from 9th of February 2019 onwards except for some member states with an existing Verification System. Packaging lines have to be equipped with systems for printing and reading two dimensional codes (2D-Codes) and these systems have to be linked to the materials management system. Companies already shipping serialized products have been reporting from technical hurdles which should not be underestimated. Most companies without experience in this field will need external help. But technical expertise could become rare in the near future.
There are numerous requirements which have to be fulfilled in the packaging plant. During this GMP course we will focus on:
Compliance & QA requirements
Hygiene and Cleaning
Qualification / Validation
Facility and Zone Concepts
Design of packaging equipment
Handling, storage and mix-ups
Serialisation & Authentication
Highly Potent Products
Staff from QA and production engaged in packaging operations is the target group of this course as well as suppliers for equipment and packaging material used for packaging of medicinal products
ProgrammeGMPs and QA oversight for packaging operations
General GMP requirements for Packaging Operations / Key Compliance Challenges for Packaging Operations
- GMP requirements in the packaging unit
- Important Guidelines and standards
- QA Systems relevant for packaging operations
- Frequent inspection findings
Packaging facilities & premises
- Handling and storage of packaging materials
- Stability issues
- Material storage, returned goods, quarantine
- Line Clearance
- Documentation practice
- Practical GMP aspects
- Good and bad practice
GMP Design Aspects for Packaging Lines
- Requirements for the technical building equipment
- Zone Concepts for primary and secondary packaging
- Air-Lock concepts
Case Study: Serialization and Aggregation - How we implemented, what worked and what didn’t
- Design criteria for blister machines, cartoners, labelers
- Differences to aseptic filling / packaging
- What is critical?
- What to write in an URS?
Workshops & Interactive Session
Workshop on Qualification and Validation
- 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
Workshop on Packaging
- Equipment qualification
- Process validation
- Critical issues which have to be tested
- How to test?
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.
How to minimize risk in Sterile Packaging
- Hygiene and Zone Concepts
- Material flow
- Line clearance procedure
- IPCs in the packaging process
- Documentation and control
- Handling of variable printing data
The application of GxP in packaging supply
- 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)
Reducing risk through supplier auditing
- Relevant ISO standards
- Introduction to British “GMP for Packaging Materials”: PS 9000:2016
- How much GMP must a supplier have?
- Practical audit aspects: what to examine?
- Qualification of suppliers