“EXCiPACT™ and PS 9000 : ‘The Latest in GMP Standards and Certification’ for Pharmaceutical Excipients And Packaging Materials”

The Pharmaceutical Quality Group (PQG), launched its updated PS 9000 packaging materials standard (PS 9000:2011) last September. Whilst this Standard reflects requirements of ISO 9001:2008 and ISO 15378:2006, and may be utilized for certification purposes, organizations cannot claim conformity unless their quality management systems conform to all the requirements of ISO 9001:2008 and/or ISO 15378:2006, although certification assessments can be carried out Simultaneously.

Also IPEC Federation will launch EXCiPACT on 25 January 2012. This will provide GMP and GDP Annexes for ISO 9001:2000 for manufacturers and distributors of excipients. This new standard is widely supported by the European and American Regulators, as a way of introducing GMP standardisation into to the manufacturing and distribution of excipients.

The implementation of the revised PS 9000:2011 and EXCiPACT is a huge step forward in bringing a standardised and understanding approach to Printed Packaging materials and Excipients GMP Compliance and would take India straight into the very latest in GMP standards.

At this Workshop, Allan Whiston is representing both EXCiPACT and the PQG to introduce us to the EXCiPACT scheme and the PS 9000 Standard Certification Scheme. In addition, Allan was a member of several committees who developed the EXCiPACT Scheme, including the team who developed the GDP annex for ISO 9000:2008. In addition, drawing from her considerable experiences with Indian Manufacturers of Excipients and packaging materials, Ms. Perviz adds the practical flavour to the workshops; how Indian companies can bridge the gap between the existing scenario and meeting the requirements of these new standards in manufacturing.

“Development of Medical Writing Skills: Writing for Regulatory Documents”

In this authoring-skills workshop, participants will be introduced to the concept of quality standards, document design tools, and scientific writing techniques that help ensure clinical manuscripts and regulatory submission documents are message-focused, clear and precise, and easy to use for the reader. Participants will learn to identify what is done well in exhibit documents as well as find and discuss how communication weaknesses can be minimized or eliminated.

Since the last 17 years, Gregory Cuppan has worked with over 60 pharmaceutical companies, both large and small, in the US, Europe, and Japan, and has been helping teams and companies plan and articulate document development strategies and find ways to bring team intelligence to the final written products. Apart from Scientific Writing Skills, Mr. Cuppan expertise also includes knowledge of technical communication, information design, communication technology, and organizational communication. From the Indian perspective, Devjani Dasgupta will address practical issues faced in the Indian context and how to resolve them.