Roundtable discussion on proposed Manufacturing Classification System
Friday 2 October 2015
E11, 1.5 hours
Organised by the FIP Industrial Pharmacy Section and the FIP SIG on Formulation Design and Pharmaceutical Technology
Development of new pharmaceutical products and the manufacturing processes needed to produce them is a complex, expensive and risky activity. In recent years, several initiatives have been introduced as a result of cooperation between the pharmaceutical industry and regulatory authorities, with the aim of simplifying the process and reducing risk. Examples include Quality by Design (QbD) and the Biopharmaceutics Classification System (BCS). There is now a proposal, originally developed by the Academy of Pharmaceutical Sciences (APSGB), to introduce a Manufacturing Classification System (MCS) to help define the properties which would make specific manufacturing processes most suitable for a particular product. An initial proposal has been published (Pharm Dev Technol, DOI: 10.3109/10837450.2014.954728, August 2014) and is open for discussion with the intention of developing a more detailed document that would eventually form the basis of an agreement with regulatory agencies.
At the conclusion of the session, participants will be able to:
- Describe the advantages and disadvantages of an MCS.
- Identify the steps to establish an MCS and gain acceptance within the industry.
- Describe the potential uses of an MCS in the development of new products.
- Outline the characteristics of drugs and formulations that should be considered when selecting a manufacturing process.
Chairs: Linda Hakes (FIP IPS, Germany) and Giovanni Pauletti (FIP SIG on Formulation Design and Pharmaceutical Technology, USA)