Docket Management
Docket: 02D-0509 - Intl Conference on Harmonisation/M4 Common Technical Documents
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Dr. Susan Mondabaugh Date/Time 2003-02-28 16:37:42
Organization Hurley Consulting Associates Ltd.
Category Company

Comments for FDA General
Questions
1. General Comments Section 2.2 of the guidance document discusses pagination and segregation of documents within the Quality Module. The following comments are submitted for consideration: We agree that individual documents should be numbered internally within that document. However, in a paper-based submission, the addition of a unique header or footer to each document that identifies its subject matter may not be possible or practical for older “legacy” documents or certain other documents such as specifications, certificates of analysis, analytical methods, and master batch records that are included in the submission. Section 2.3 of the guidance document discusses formatting of table of contents of documents within the Quality Module. The following comments are submitted for consideration: We agree with the concept of maintaining a high level table of contents for the Module 3 table of contents (3.1), and the concept of providing detailed table of contents within other documents contained in Module 3 that would not appear in 3.1. We also agree and understand having more than one page number, such as at the document level and the module level on documents can lead to confusion for reviewers, particularly when companies adopt their own unique pagination system. However, for a paper-based submission, not including either volume page numbers or Module page numbers with reliance on tabs to locate information may make locating information within the Module difficult or tedious for reviewers. Additionally, tabs can sometimes be easily torn or damaged, which renders their utlity as a navigation tool for the module useless. Therefore, it is suggested that FDA provide a standardized numbering system for modules for paper-based submissions.




EC -1