Speakers
Reduced Sampling / Reduced Testing
Emerich Grassinger
Aenova Group - Haupt Pharma Wülfing GmbH, Germany
Dr Matthias Heuermann
NRW Centre for Health (LZG.NRW), Germany
Dr Gerald Kindermann
F. Hoffmann-La Roche, Switzerland
Dr Michael Möhlen
Valneva Austria GmbH, Austria
Dr Bernd Renger
Bernd Renger Consulting, Germany
Dr Martin Wesch
Wesch & Buchenroth, Law Office, Germany
Quality of Inhalation Drug Products
Dr Carol Barbour
Intertek Melbourn, Melbourn, UK
Dr Manfred Fischer
SkyePharma, Muttenz, Switzerland
Dr Armin Hauk
Intertek Life Science, Switzerland
Dr Rudi Müller-Walz
SkyePharma, Muttenz, Switzerland
Derek Solomon
Intertek Melbourn, Melbourn, UK
Objectives
Reduced Sampling / Reduced Testing
The aim of this course is to demonstrate the process of the qualification of starting materials (APIs and excipients) and packaging materials (primary and secondary) and to define the prerequisites for implementing a system for reduced sampling and reduced testing for these products. This system has to be in compliance with the actual GMP requirements in Europe and in the US, though. Case Studies will show how to define and optimise sampling and testing procedures and you will discuss further details in a parallel session with 3 workshops.
Quality of Inhalation Drug Products
This GMP Education Course on Inhalation Drug Products aims at providing delegates with a sound understanding and best practices in the development and analytical quality control of Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products. The course provides a comprehensive overview of the regulatory requirements in Europe and U.S. (Ph.Eur., USP, FDA, and EM(E)A) and shows how all these requirements can be put into practice.
Background
Reduced Sampling / Reduced Testing
Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the necessary tests are conducted on the incoming goods and that the materials are released only after their quality was judged as satisfactory.
According to the revised Chapter 5 – Production – of the EU GMP Guide to come into force on 1 March 2015, the selection, qualification, approval and maintenance of suppliers has to be documented and the level of control has to be proportionate to the potential risks posed by the individual materials. Manufacturers of medicinal products are responsible for testing the starting and packaging materials as described in the marketing authorisation dossier. However, it is explicitly accepted to outsource these testing activities, if the following requirements are fulfilled:
a) Distribution controls (transport, wholesaling, storage and delivery) to ensure the maintenance of the quality characteristics of the starting materials
b) Regularly performed audits at the sites carrying the testing
c) A certificate of analysis signed by a designated person with appropriate qualifications and experience
d) Significant experience in dealing with the starting
material manufacturer (“history of compliance”)
e) Full analyses that are performed regularly by the
medicinal product manufacturer to compare the results with the supplier’s certificate of analysis.
It is the aim of this GMP Education Course to show how these requirements can be put into practice.
Other focus areas of this course are the regulatory requirements for sampling, the design and qualification of sampling areas and the handling of varying specifications in the different pharmacopoeias for identical APIs and excipients used for finished drug products dedicated for the markets in Europe, in the US, and in Japan.
Must different tests be conducted according to EP, USP, and JP, respectively?
The course programme will be completed by a lawyer’s presentation about the legal and contractual liability of suppliers for defect products.
Quality of Inhalation Drug Products
The market for inhalation drug products has become increasingly important and at the same time the number of
requirements from regulatory authorities has increased.
Key guidance documents and relevant pharmacopoeial General Chapters are:
FDA Draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI),
EM(E)A: Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products,
Ph.Eur. 2.9.18, Preparations for Inhalation (Inhalanda),
USP <601> Aerosols, Nasal Sprays, Metered Dose Inhalers, and Dry Powder Inhalers.
Pharmaceutical development based on Quality by Design (QbD) principles is key to achieve inhalation drug products of high reproducible performance. Extensive characterisation of the drug substance and drug product batches is necessary to qualify an inhalation drug product for its intended use - the delivery of the drug substance into the lungs.
Challenging issues in the development and control of inhalation drug products are:
Physical characterisation of starting materials
Control of extractables and leachables
Reproducibility of the delivered dose
Constant particle size distribution throughout
shelf-life
Patient friendly performance characteristics of the drug product
The objective of this course is to cover all aspects of development and analytical testing of Inhalation Products with a focus on practical examples.
Workshops are an essential part of the course in order to encourage the exchange of experience and to allow interactive and in depth discussion of the subject.
Target Group
Reduced Sampling / Reduced Testing
This GMP Education Course is directed at all those employees from quality control units in the pharmaceutical industry (including heads of quality control and laboratory managers) who are competent or responsible for sampling, testing and release of starting materials (APIs and excipients) and packaging materials (primary and secondary). This course is also of interest to personnel from quality assurance and to those employees from API, excipient or packaging material suppliers who want to inform themselves about the requirements of the pharmaceutical industry on the testing of these materials.
Quality of Inhalation Drug Products
This course is dedicated to scientists and managers in the pharmaceutical industry working in
Quality control
Quality assurance
Analytical development
Formulation and process development
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