Description
The Pharmaceutical Industry is currently facing a challenging environment in which to operate. As a consequence, rationalisation of manufacturing operations is a significant activity for many companies as it targets cost savings and operational efficiency. This focus will continue for the foreseeable future as the industry continues to re-structure.
Transferring the manufacture of APIs, registered Intermediates, IMPs and Drug Products to different sites whilst ensuring continuity of supply poses significant and complex regulatory, GMP and logistics challenges. This is especially challenging when conducted across diverse global markets with different regulatory requirements and times scales.
In particular, companies are increasingly transferring production to manufacturing centres in emerging markets such as India and China.
This seminar will provide you with an overview of the regulatory, production, quality, logistics and project management considerations required for the efficient and effective transfer of both API and Drug Products between manufacturing sites. It will also provide advice on the co-ordination of these activities with name changes, packaging and formulation rationalisation.
The seminar is intended to provide an overview of the practical problems and pitfalls associated with global manufacturing site transfers with an additional focus on production transfers to India and China. Case Studies will focus on major manufacturing rationalisation projects recently undertaken by industry. This seminar does not cover Biologicals or Vaccines, although the general principles are common for such supply.
