PharmaLab Congress 2016
   

Microbial Safety of Raw Materials and Excipients

9 November 2016


Objectives:

This conference is designed to provide you information of the pharmacopoeial requirements, possible issues with special substances, microbiological challenges and necessary tests during life cycle.

During this Conference we discuss:

  • International regulatory requirements
  • What should be tested
  • Skip lot testing
  • Specific pitfalls e.g. toxicity issues, inhomogenous distribution of contaminants
  • Storing and retesting

Background:

The quality of raw materials and excipients is one of the important factors for a suitable final product. With the implementation of the EU Directive 2001/83/EC into national law, all active pharmaceutical ingredients and the yet-to-be-defined Certain Excipients used in pharmaceutical manufacturing must be produced in compliance with current Good Manufacturing Practice (cGMP). As the current regulation is limited the legal enforceability is and will remain difficult. There is no Commission Directive on GMP for certain excipients for the time being and the preparation of such a Directive will not be continued as originally foreseen in Article 46(f) of Directive 2001/83/EC. However a series of recent incidents with tragic consequences for public health showed excipients of substandard quality to be involved and presents a global challenge for both the producer and user of pharmaceutical excipients. Against the background of the current situation the need of compulsory quality standards for manufacture and distribution of pharmaceutical excipients is quite obvious.

Target Audience:

  • Employees and senior staff of manufacturers of raw materials and excipients
  • QA/QC micribiological laboratory staff
  • Contract Laboratories
  • Production and purchase departments

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