If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: email@example.com
Buket Hekiman Bayraktar, PharmaVision San. ve Tic. A.S.
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 30% 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. These measures will have to become active by 2016/2017 the latest. Packaging lines will have to be equipped with systems for printing and reading 2D-
Barcodes 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.
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
Packaging facilities & premises
Requirements for the technical building equipment
Zone Concepts for primary and secondary packaging
Handling of Packaging Materials
Handling and storage of packaging materials
Compliance for Packaging Operations
Material storage, returned goods, quarantine
Practical GMP aspects
Good and bad practice
GMP Design for packaging equipment
Design criteria for blister machines, cartoners, labelers
Differences to aseptic filling / packaging
What is critical?
What to write in an URS?
Product Serialization and Authentication - 6 Years of experience: how to cope with country specific requirements and implementation of new technology?
Authentication & Serialisation – basic information
Scope and main characteristics of Track & Trace
System in Turkey
General aspects on required equipment for Serialization and Authentication
Regulatory aspects and timeline for implementation in phases
Impact of Serialization and Authentication on production processes
Qualification and Validation
Critical issues which have to be tested
How to test?
Case Study: Track & Trace Application with focus on Quality and Compliance
Implementation at PharmaVision, a pure CMO
Frequently faced problems & Facts as of 2016
Management assessment: Challenges & Proposed solutions
Packaging of highly potent products in a GMP environment
Avoidance of cross contamination
What has to be considered for packaging of (solid) highly potent medicines (primary + secondary)
Special requirements for the packaging (filling) of sterile products
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
Audit of packaging material suppliers
Relevant ISO standards
How much GMP must a supplier have?
Practical audit aspects: what to examine?
Qualification of suppliers