Avoiding non-Compliance in Packaging Operations

Avoiding non-Compliance in Packaging Operations

Berlin, Germany

Course No 16839


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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
QA Systems
Hygiene and Cleaning
Qualification / Validation

Technological aspects
Facility and Zone Concepts
Design of packaging equipment

Packaging materials
Handling, storage and mix-ups

Special topics:
Serialisation & Authentication
Highly Potent Products

Target Group

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


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
  • Testing
  • 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
  • Hygiene
  • HVAC
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
Workshops & Interactive Session

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

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