Here are my top 10 reasons why a company would want to be associated with a recognized and well respected organization dedicated to patient safety by ensuring that the components of drug products are safe and of sufficient quality to ensure they function properly in the drug product.
William Dale Carter
Past Chairman, IPEC-Americas
Head of Quality - Silicas
1. Input into the development and writing of guidance for excipients via committees made up of a balanced group of both excipient users and makers.
2. Updates on regulations from around the world through IPEC-Americas
3. Direct interaction with regulatory individuals from your suppliers/customers.
4. Networking opportunities with other pharma companies to get perspective on how the industry is addressing common challenges such as supplier’s not allowing on-site inspections or the lack of a reliable supplier of a USP grade component.
5. A forum to educate global policy makers (US FDA, USP, global regulators and trade associations) through committee participation
6. Access to other working groups and USP stakeholder forums as an IPEC member.
7. Opportunity to contribute to IPEC Conference agendas to solicit public comment for topics of interest to your company.
8. Input into the global harmonization process for compendial monographs, including selection of candidates for harmonization as well as feedback on early drafts. Most up to date information from Compendial Review Committee (CRC) on monographs in the harmonization program.
9. Discussion on future publications for the Pharmacopeia Forum to keep abreast of changes to the USP.
10. Ability to comment on regulation or USP activities through a recognized and well respected organization dedicated to safe excipients.