|Non-ECA Members:||EUR 1690,--|
|ECA Members:||EUR 1490,--|
|EU GMP Inspectorates:||EUR 845,--|
|APIC Members (does not include ECA membership):||EUR 1590,--|
(All prices excl. VAT)
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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
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 in operation since 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) Audits performed at appropriate intervals at the sites carrying out 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 or a contract laboratory acting on behalf of the 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.
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.
Regulatory Requirements for Sampling Procedures