The Excipient Control Working Group of PQRI * is seeking information from Excipient Manufacturers, Excipient Distributors, and Pharmaceutical Companies regarding their practices to reduce redundant testing of excipient attributes for complying with the requirements of multiple pharmacopoeias (namely, USP-NF, Ph.Eur., and JP). This information will be used to help establish recommendations for global harmonization of excipient specifications and to determine the appropriate control procedures needed for demonstration of global compendial compliance. Additionally, this questionnaire will collect information on the types of non-compendial physical and chemical testing done by excipient users, if any, on the batches of an excipient they receive from one or more excipient manufacturers (or suppliers), to determine its suitability for the processing of their drug product batches, and also for deriving the functionality of the excipient in the drug product. This effort will provide benefits for all parties involved, as well as the FDA.
PQRI will publish the results and analyses of the responses received in connection with this survey on its website, as well in other widely circulated pharmaceutical journals and periodicals.
Deadline for submission of the survey responses is October 12, 2005.
INSTRUCTIONS FOR COMPLETING THE SURVEY:
To access the Excipient Control Survey Questionnaire please click the following link, or copy and paste into your search engine:
https://www.surveysage.com/SR/OpenSrvy.asp?nOpen=1728&nAC=7049963
IT IS ESTIMATED THAT THIS QUESTIONNAIRE WILL TAKE APPROXIMATELY 30 MINUTES TO COMPLETE. (Should you not complete the survey in your first sign on and wish to go back to finish at a later time, you may do so by using the password given you upon your initial sign on.)
If more than one supply chain function applies to one company, separate responses are requested from the following three functions:
Excipient manufacturer; and/or Excipient distributor; and/or Excipient user
Please answer all questions that are relevant to the excipients you manufacture, distribute, or use. This information will be collected confidentially, and the respondent will not be identified. However, all of your responses will be available to the Excipient Working Group, including our statistician who will be analyzing the results. The data is for research purposes only. It is important to receive data from as many excipient manufacturers, excipient distributors and excipient users as possible to enhance the relevance of survey findings. Therefore, PQRI encourages your participation in this survey.
If multiple people within your organization may be involved in the development or implementation of your excipient control practices, or you utilize different approaches at different locations, please forward this questionnaire to the appropriate people who can provide detailed information that may be useful to PQRI. More than one response from a particular company is acceptable.
TROUBLESHOOTING:
In case of difficulty or problems with completing the on-line form, or for troubleshooting, access, or performance issues with the survey please contact:
Stacey D'Amico, Senior Associate(sdamico@valtera.com)
Phone:847-472-5729
Fax:847-640-8830
*The Excipient Control Working Group (XWG) is a group established under the auspices of the Drug Product Technical Committee (DPTC) of the Product Quality Research Institute (PQRI) to examine issues surrounding pharmaceutical excipient controls. The Working Group consists of members from the pharmaceutical industry (innovator and generic manufacturers, excipient suppliers, USP, and the FDA). The composition of the group and information concerning the XWG and PQRI are available at the questionnaire website, and additional information can be found at PQRI’s website (www.pqri.org).