7-8 March 2018
Maren Göpfert, Boehringer Ingelheim Pharma
David Abraham, QRS & Project Leader in the development of the PS 9000:2016
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 about 30nbsp;% of recalls of tablet products during the last 5 years were caused by label mix-ups, incorrect packaging or incorrect products insert. The number of field alerts tripled between 2009 and 2012. 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 will be applied from 9th of February 2019 onwards except for some member states with an existing Verification System. Packaging lines will have to be equipped with systems for printing and reading two dimensional codes (2D-Codes) and these systems will 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 for packaging equipment
- Requirements for the technical building equipment
- Zone Concepts for primary and secondary packaging
- Air-Lock concepts
- 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 to implement in Packaging and Supply Chain?
Case Study: Quality and Compliance systems in the packaging plant
- 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
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.
Packaging of highly potent products in a GMP environment
- Hygiene and Zone Concepts
- Material flow
- Line clearance procedure
- IPCs in the packaging process
- Documentation and control
- Handling of variable printing data
Special requirements for the packaging (filling) of sterile products
- Avoidance of cross contamination
- What has to be considered for packaging of (solid) highly potent medicines (primary+secondary)
The application of GxP in packaging supply
- The two manufacturing modes for sterile products: aseptic filling and terminal sterilization
- The physical characteristics of the primary packaging components and their physico-chemical attributes (the challenge of departiculated & depyrogenated packaging materials
- The microbiological quality of the primary packaging components
- Integrity of the product: importance of the resistance of primary packaging components; importance of the integrity testing
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
Workshop on Qualification and Validation
Workshop on Packaging
- Equipment qualification
- Process validation
- Critical issues which have to be tested
- How to test?
- Secondary Packaging (including Medical Devices)